CAM 701101

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Category:Surgery   Last Reviewed:July 2019
Department(s):Medical Affairs   Next Review:July 2020
Original Date:June 2010    

Description:
Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. For patients who have failed conservative therapy, established surgical approaches may be indicated. This evidence review addresses minimally invasive surgical procedures for the treatment of OSA. They include laser-assisted uvuloplasty, tongue base suspension, radiofrequency volumetric reduction of palatal tissues and base of tongue, palatal stiffening procedures, and hypoglossal nerve stimulation. This evidence review does not address conventional surgical procedures such as uvulopalatopharyngoplasty, hyoid suspension, surgical modification of the tongue, maxillofacial surgery, or adenotonsillectomy.

For individuals who have OSA who receive laser-assisted uvulopalatoplasty, the evidence includes a single randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The trial indicates reductions in snoring, but limited efficacy on the Apnea/Hypopnea Index (AHI) or symptoms in patients with mild-to-moderate OSA. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive a radiofrequency volumetric reduction of palatal tissues and base of tongue, the evidence includes 2 sham-controlled randomized trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Single-stage radiofrequency to palatal tissues did not improve outcomes compared with sham. Multiple sessions of radiofrequency to the palate and base of tongue did not significantly (statistically or clinically) improve AHI, and the improvement in functional outcomes was not clinically significant. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive palatal stiffening procedures, the evidence includes two sham-controlled randomized trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The 2 RCTs differed in their inclusion criteria, with the study that excluded patients with Friedman tongue position of IV and palate of 3.5 cm or longer reporting greater improvement in AHI (45% success) and snoring (change of -4.7 on a 10-point visual analog scale) than the second trial. Additional study is needed to corroborate the results of the more successful trial and, if successful, define the appropriate selection criteria. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive tongue base suspension, the evidence includes a feasibility RCT with 17 patients. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT compared tongue suspension plus uvulopalatopharyngoplasty with tongue advancement plus uvulopalatopharyngoplasty and showed success rates of 50% to 57% for both procedures. RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to uvulopalatopharyngoplasty improves the net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive hypoglossal nerve stimulation, the evidence includes two nonrandomized studies with historical controls and prospective single-arm studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Hypoglossal nerve stimulation has shown success rates for about two-thirds of a subset of patients who met selection criteria that included AHI, body mass index, and favorable pattern of palatal collapse. These results were maintained out to five years in the pivotal single-arm study. Clinical input supplements and informs the interpretation of the published evidence. Clinical input indicates that HNS leads to a meaningful improvement in health outcomes in appropriately selected adult patients with a favorable pattern of non-concentric palatal collapse. The alternative treatment for this anatomical endotype is maxillo-mandibular advancement (MMA), which is associated with greater morbidity and lower patient acceptance than HNS. The improvement in AHI with HNS, as shown in the STAR trial, is similar to the improvement in AHI following MMA.  Clinical input also supports that HNS results in a meaningful improvement in health outcomes in appropriately selected adolescents with OSA and Down’s syndrome who have difficulty in using CPAP. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria which are based on information from clinical study populations and clinical expert opinion.

  • Age ≥ 22 years in adults or adolescents with Down’s syndrome age 10 to 21; AND 
  • Diagnosed moderate to severe OSA (with less than 25% central apneas); AND
  • CPAP failure or inability to tolerate CPAP; AND
  • Body mass index ≤ 32 kg/min adults; AND
  • Favorable pattern of palatal collapse 

Background
Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep. The hallmark symptom of OSA is excessive daytime sleepiness, and the typical clinical sign of OSA is snoring, which can abruptly cease and be followed by gasping associated with a brief arousal from sleep. The snoring resumes when the patient falls back to sleep, and the cycle of snoring/apnea/arousal may be repeated as frequently as every minute throughout the night. Sleep fragmentation associated with the repeated arousal during sleep can impair daytime activity. For example, adults with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles (ie, cars, trucks, heavy equipment). OSA in children may result in neurocognitive impairment and behavioral problems. In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxia, alveolar hypoventilation, hypercapnia, and acidosis. This, in turn, can cause systemic hypertension, cardiac arrhythmias, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to overwhelming sleepiness.

Regulatory Status
The regulatory status of minimally invasive surgical interventions is shown in Table 1.

Table 1. Minimally Invasive Surgical Interventions for Obstructive Sleep Apnea

Interventions

Devices (predicate or prior name)

Manufacturer (previouslyowner)

Indication

PMA/ 510(k)

Year

FDA Product Code

LAUP

Various

 

 

 

 

 

Radiofrequency ablation

Somnoplasty®

 

Simple snoring and for the base of the tongue for OSA

K982717

1998

GEI

Palatal Implant

Pillar® Palatal Implant

Pillar Palatal (Restore Medical/ Medtronic)

Stiffening the soft palate which may reduce the severity of snoring and incidence of airway obstructions in patients with mild-to-moderate OSA

K040417

2004

LRK

Tongue base suspension

AIRvance® (Repose)

Medtronic

OSA and/or snoring. The AlRvance TM Bone Screw System is also suitable for the performance of a hyoid suspension

K122391

1999

LRK

 

Encore™ (PRELUDE III)

Siesta Medical

Treatment of mild or moderate OSA and/or snoring

K111179

2011

ORY

Hypoglossal nerve stimulation

Inspire II Upper Airway Stimulation

Inspire Medical Systems

“a subset of patients with moderate to severe obstructive sleep apnea”

(AHI ≥20 and ≤65) in adults ≥22 years who have failed (AHI >15 despite CPAP usage) or cannot tolerate (<4 h use per night for ≥5 nights per week) CPAP and do not have complete concentric collapse at the soft palate level. Failure includes unwillingness to use CPAP.

P130008

2014

MNQ

 

aura6000®

ImThera Medical

 

IDE

2014

 

AHI: Apnea/Hypopnea Index; CPAP: continuous positive airway pressure; IDE: investigational device exemption; LAUP: Laser-assisted uvulopalatoplasty; OSA: obstructive sleep apnea.

Related Policies
20118 Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome

Policy:
Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) may be considered MEDICALLY NECESSARY for the treatment of clinically significant obstructive sleep apnea (OSA) syndrome in appropriately select adults who have failed an adequate trial of continuous positive airway pressure (CPAP) or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those patients who have:

  • Apnea/Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of 15 or more events per hour, or
  • AHI or RDI of 5 or more events and 14 or less events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), may be considered MEDICALLY NECESSARY in appropriately selected adults with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have failed an adequate trial of CPAP or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those patients who have:

  • AHI or RDI of 15 or more events per hour, or
  • AHI or RDI of 5 or more events and 14 or less events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

Adenotonsillectomy may be considered MEDICALLY NECESSARY in pediatric patients with clinically significant OSA and hypertrophic tonsils. Clinically significant OSA is defined as those pediatric patients who have:

  • AHI or RDI of at least 5 per hour, or
  • AHI or RDI of at least 1.5 per hour in a patient with excessive daytime sleepiness, behavioral problems, or hyperactivity.

Hypoglossal nerve stimulation may be considered medically necessary in adults with OSA under the following conditions:

  •  Age ≥ 22 years; AND
  •  AHI ≥ 20 with less than 25% central apneas; AND
  • CPAP failure (residual AHI ≥ 20 or failure to use CPAP ≥ 4 hr per night for ≥ 5 nights per week) or inability to tolerate CPAP; AND
  • Body mass index ≤ 32 kg/m2; AND
  • Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (see Policy Guidelines). 

Hypoglossal nerve stimulation may be considered medically necessary in adolescents or young adults with Down syndrome and OSA under the following conditions:

  • Age 10 to 21 years; AND
  • AHI >10 and <50 with less than 25% central apneas after prior adenotonsillectomy; AND
  • Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device; AND
  • Body mass index ≤ 95th percentile for age; AND
  • Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (See Policy Guidelines). 

Surgical treatment of OSA that does not meet the criteria above would be considered not medically necessary.

The following minimally invasive surgical procedures are considered INVESTIGATIONAL for the sole or adjunctive treatment of OSA or upper airway resistance syndrome:

  • Laser-assisted palatoplasty or radiofrequency volumetric tissue reduction of the palatal tissues
  • Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues
  • Palatal stiffening procedures including, but not limited to, cautery-assisted palatal stiffening operation, injection of a sclerosing agent, and the implantation of palatal implants
  • Tongue base suspension
  • All other minimally invasive surgical procedures not described above.

Implantable hypoglossal nerve stimulators are considered INVESTIGATIONAL for all indications other than listed above.

All interventions, including laser-assisted palatoplasty, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered NOT MEDICALLY NECESSARY for the treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical condition.

Policy Guidelines
Clinically significant obstructive sleep apnea (OSA) is defined as those adult patients who have either of these:

  • Apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 15 events per hour
  • AHI or RDI greater than or equal to five events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke

The AHI is the total number events (apnea or hypopnea) per hour of recorded sleep. The RDI is the total number events (apnea or hypopnea) per hour of recording time. An obstructive apnea is defined as at least a 10-second cessation of respiration associated with ongoing ventilatory effort. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4 percent oxygen desaturation.

The presentation of OSA in pediatric patients may differ from that of adults. OSA in pediatric patients is defined as those who have either of these:

  • AHI or RDI of at leasfive per hour
  • AHI or RDI of at least 1.5 per hour in a patient with excessive daytime sleepiness, behavioral problems or hyperactivity

Clinically significant upper airway resistance syndrome (UARS) is defined as greater than 10 EEG arousals per hour. The presence of abnormally negative intrathoracic pressures (i.e., more negative than 10 cm) in conjunction with the EEG arousals supports the diagnosis. The measurement of intrathoracic pressures requires the use of an esophageal manometer as an adjunct to a polysomnogram. Objective evidence of hypopharyngeal obstruction is documented by either fiberoptic endoscopy or cephalometric radiographs.

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may only be assessed on the basis of their medical necessity. This consideration would apply to radiofrequency volumetric tissue reduction.

Rationale
This review was informed by TEC Assessments on the surgical management and radiofrequency volumetric tissue reduction for obstructive sleep apnea (OSA).1,2

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function -- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Obstructive Sleep Apnea
Clinical Context and Therapy Purpose
OSA is associated with a heterogeneous group of anatomic variants producing obstruction. The normal pharyngeal narrowing may be accentuated by anatomic factors, such as a short, fat “bull” neck, elongated palate and uvula, and large tonsillar pillars with redundant lateral pharyngeal wall mucosa. In addition, OSA is associated with obesity. OSA may also be associated with craniofacial abnormalities, including micrognathia, retrognathia, or maxillary hypoplasia. Obstruction anywhere along the upper airway can result in apnea. The severity and type of obstruction may be described with the Friedman staging system.3, Nonsurgical treatment for OSA or upper airway resistance syndrome includes continuous positive airway pressure (CPAP) or mandibular repositioning devices, which are addressed in evidence review 2.01.18. Patients who fail conservative therapy may be evaluated for surgical treatment of OSA.

Traditional surgeries for OSA or upper airway resistance syndrome include uvulopalatopharyngoplasty (UPPP) and a variety of maxillofacial surgeries such as mandibular-maxillary advancement. UPPP involves surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula. The amount of tissue removed is individualized for each patient, as determined by the potential space and width of the tonsillar pillar mucosa between the 2 palatal arches. UPPP enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Patients who have minimal hypoglossal obstruction have greater success with UPPP. Patients who fail UPPP may be candidates for additional procedures, depending on the site of obstruction. Additional procedures include hyoid suspensions, maxillary and mandibular osteotomies, or modification of the tongue. Drug-induced sleep endoscopy and/or cephalometric measurements have been used as methods to identify hypopharyngeal obstruction in these patients. The first-line treatment in children is usually adenotonsillectomy. Minimally invasive surgical approaches are being evaluated for OSA in adults.

The question addressed in this evidence review is: Do the surgical interventions addressed in this evidence review improve the net health outcome in patients with OSA?

The following PICOTS were used to select literature to inform this review.

Patients
The population of interest includes patients with OSA who have failed or are intolerant of positive airway pressure.Definitions of terms for OSA are shown in Table 2. Indications for the various procedures are described in Table 3 and in the Regulatory Status section.

Table 2. Definitions of Terms for Obstructive Sleep Apnea

Interventions

Devices

Description

Key Features

Indications

LAUP

Various

Superficial palatal tissues are sequentially reshaped over 3 to 7 sessions using a carbon dioxide laser

  • Part of the uvula and associated soft-palate tissues are reshaped
  • Does not alter tonsils or lateral pharyngeal wall tissues
  • Tissue ablation can be titrated

Snoring with or without OSA

RF volumetric reduction of palatal tissues and base of tongue

Somnoplasty

 

Radiofrequency is used to produce thermal lesions within the tissues

  • Similar to LAUP
  • Can include soft palate and base of tongue

Simple snoring and base of tongue OSA

Palatal Implant

Pillar Palatal Implant

Braided polyester filaments that are implanted submucosally in the soft palate

Up to 5 implants may be used

Snoring

Tongue base suspension

AIRvance Encore

A suture is passed through the tongue and fixated with a screw to the inner side of the mandible, below the tooth roots

The aim of the suspension is to make it less likely for the base of the tongue to prolapse during sleep

Snoring and/or OSA

Hypoglossal nerve stimulation (HNS)

Inspire II Upper Airway Stimulation

Stimulation of the hypoglossal nerve which contracts the tongue and some palatal tissue

The device includes an implanted stimulator and a sensor implanted in the ribs to detect respiration.

A subset of patients with moderate-to-severe OSA who have failed or cannot tolerate CPAP (see Regulatory Status section)

CPAP: positive airway pressure; LAUP: laser-assisted uvulopalatoplasty; OSA: obstructive sleep apnea; RF: radiofrequency.

Comparators
The following therapies and practices are currently being used to treat OSA:

For patients with mild OSA who are intolerant of CPAP, the comparator would be oral appliances (see Evidence Review 2.01.18 on diagnosis and medical management of OSA) or an established upper airway surgical procedure.

For patients with moderate-to-severe OSA who have failed CPAP or are intolerant of CPAP, the comparator would be maxillofacial surgeries that may include UPPP, hyoid suspensions, maxillary and mandibular osteotomies, and modification of the tongue. UPPP alone has limited efficacy.4, UPPP may be modified or combined with a tongue base procedure such as uvulopalatopharyngoglossoplasty, depending on the location of the obstruction. UPPP variants would not be the most appropriate comparator for HNS, since the procedures address different sources of obstruction.

Established surgical procedures are associated withadverse events such as dysphagia. In addition, the surgical procedures are irreversible should an adverse event occur. Therefore, an improvement in effectiveness and/or a decrease in adverse events compared with standard surgical procedures would be the most important outcomes.

Outcomes
The outcomes of interest are a decrease in Apnea/Hypopnea Index (AHI) and Oxygen Desaturation Index on polysomnography (PSG) and improvement in a measure of sleepiness such as the Epworth Sleepiness Scale (ESS) or Functional Outcomes of Sleep Questionnaire (FOSQ) (see Table 4).

Table 4. Health Outcome Measures Relevant to OSA

Outcome

Measure (Units)

Description

Clinically Meaningful Difference (If Known)

Change in AHI

AHI

Mean change in AHI from baseline to post-treatment

Change from severe to moderate or mild OSA

AHI Success

Percentage of patients achieving success.

Studies may use different definitions of success; the most common definition of AHI success is the Sher criteria

Sher criteria is a decrease in AHI ≥50% and an AHI <20

Alternative measures of success may be AHI <15, <10, or <5

Oxygen Desaturation Index

Oxygen levels in blood during sleep

The number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points

More than 5 events per hour

Snoring

10-point visual analog score

Filled out by the bed partner to assess snoring intensity or frequency

There is no standard for a good outcome. Studies have used 50% decrease in VAS5, or final VAS of <5 or <36,

Epworth Sleepiness Score (ESS)

Scale from 0 to 24

The ESS is a short self-administered questionnaire that asks patients how likely they are to fall asleep in 8 different situations such as watching TV, sitting quietly in a car, or sitting and talking to someone

An ESS of ≥10 is considered excessively sleepy

Functional Outcomes of Sleep Questionnaire

30 questions

Disease-specific quality of life questionnaire that evaluates functional status related to excessive sleepiness

A score of ≥18 is the threshold for normal sleep-related functioning, and a change of ≥2 points is considered to be a clinically meaningful improvement

AHI: Apnea/Hypopnea Index; VAS: visual analog score.

Timing
The effect of surgical treatment of OSA should be observed on follow-up PSG that would be performed from weeks to months after the surgery. Longer term follow-up over 2 years is also needed to determine whether the effects of the procedure are durable or change over time.

Setting
Referral for a surgical procedure would be given by a primary care physician or sleep specialist following a laboratory PSG or home sleep study and home trial of CPAP.

Laser-Assisted Uvulopalatoplasty
LAUP is proposed as a treatment of snoring with or without associated OSA. LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, which raises its own issues of safety and, in particular, effectiveness.

One RCT (Ferguson et al (2003)) on LAUP has been identified.7, This trial compared LAUP with no treatment, finding treatment success (AHI <10) to be similar between LAUP (24%) and no treatment controls (17%) (see Tables 5 and 6). The primary benefit of LAUP was on snoring as rated by the bed partner. Subjective improvements in ESS and quality of life were not greater in the LAUP group in this nonblinded study (see Tables 7 and 8). Adverse events of the treatment included moderate-to-severe pain and bleeding in the first week and difficulty swallowing at follow-up.

Table 5. Summary of Key Randomized Controlled Trial Characteristics

Study

Countries

Sites

Participants

Interventions1

 

 

 

 

Active

Comparator

Ferguson et al (2003)7,

Canada

1

46 patients with mild-to-moderate symptomatic OSA (AHI of 10 to 25) and loud snoring

21 patients treated with LAUP every 1-2 mo1

25 patients received no treatment

AHI: Apnea/Hypopnea Index; LAUP: laser-assisted uvulopalatoplasty.

1The LAUP procedure was repeated at 1- to 2-month intervals until either the snoring was significantly reduced, no more tissue could safely be removed, or the patient refused further procedures. There was a mean of 2.4 procedures (range, 1-4).

Table 6. Summary of Key Randomized Controlled Trial Results

Study

Treatment Success (AHI <10)

Change in Snoring (10- point VAS)

Change in ESS

Change in SAQLI Quality of Life

Moderate-to-Severe Pain in First Week

Bleeding in First Week

Difficulty Swallowing at Follow-up

Ferguson et al (2003)7,

 

 

 

 

 

 

N

45

45

45

45

45

45

45

LAUP

24%

-4.4

-1.4

+0.4

81%

19%

19%

No treatment

17%

-0.4

+0.8

+0.2

 

 

 

p

NR

<0.001

NS

NS

 

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
AHI: Apnea/Hypopnea Index; OSA: obstructive sleep apnea.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 8. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Ferguson et al (2003)7,

 

1.-3. No blinding

 

 

 

4. Comparison of primary outcome not reported

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Laser-Assisted Uvulopalatoplasty
A single RCT has been identified on LAUP for the treatment of mild-to-moderate OSA. LAUP improved snoring as reported by the bed partner, but did not improve treatment success in terms of AHI when compared with no treatment controls. Patients in this nonblinded study did not report an improvement in ESS or quality of life after LAUP.

Radiofrequency Volumetric Reduction of Palatal Tissues and Base of Tongue
RF is used to produce thermal lesions within the tissues rather than using a laser to ablate the tissue surface. In some situations, RF of the soft palate and base of tongue are performed together as a multilevel procedure.

The analysis of RF volumetric tissue reduction was informed by a TEC Assessment (2000) that evaluated 4 primary studies on palatal radiofrequency ablation (RFA) and 1 study on tongue base RFA.2, All studies were nonrandomized.

Randomized Controlled Trials
Two RCTs have subsequently been identified on RF volumetric reduction of the palate and tongue. One of the trials (Back et al [2009]) gave a single RF treatment to palatal tissues and found no statistical difference in scores on the AHI, VAS for snoring, ESS, or FOSQ between RF and sham (see Tables 9-11).8, The second trial (Woodson et al [2003]), provided a mean of 4.8 sessions of RF to the tongue and palate.9, This trial found a statistically significant improvement from baseline to posttreatment for ESS and FOSQ. However, the improvement in the FOSQ score (1.2; standard deviation, 1.6) was below the threshold of 2.0 for clinical significance and the final mean score in ESS was 9.8, just below the threshold for excessive sleepiness. AHI decreased by 4.5 events per hour, which was not statistically or clinically significant. The statistical significance of between-group differences was not reported (see Table 12).

Table 9. Summary of Key Randomized Controlled Trial Characteristics

Study

Countries

Sites

Participants

Interventions

 

 

 

 

Active

Comparator

Black et al (2009)8,

Finland

1

32 patients with symptomatic mild OSA and habitual snoring with only velopharyngeal obstruction

Single-stage RF to palatal tissues

Sham control with local anesthetic and multiple insertions of an applicator needle without the RF

Woodson et al (2003)9,

U.S.

2

90 patients with symptomatic mild-to-moderate OSA, randomized to RF, sham, or CPAP

30 subjects received up to 7 sessions (mean, 4.8) of RF to tongue base and palate

30 subjects received sham procedure to tongue for 3 sessions, including local anesthetic and multiple insertions of an applicator needle without the RF

CPAP: continuous positive airway pressure; OSA: obstructive sleep apnea; RF: radiofrequency.

Table 10. Summary of Key Randomized Controlled Trial Results

Study

AHI

Snoring

ESS

Function

Adverse Events

 

Median (Range)

Snoring Median (Range)

Median (Range)

Compound End Point Scorea Median (Range)

 

Black et al (2009)8,

 

 

 

 

N

32

30

32

32

32

RF

13.0 (2.0-26.0)

5.0 (2.0-8.0)

7.0 (0-20.0)

6 (3-9)

 

Sham

11.0 (1.0-29.0)

6.0 (3.0-8.0)

5.0 (2.0-15.0)

7 (4-10)

 

p

0.628

0.064

0.941

0.746

No significant differences after 6 d

 

Change Score (SD)

 

Change Score (SD)

FOSQ Score (SD)

 

Woodson et al (2003)9,

 

 

 

 

N

52

 

54

54

54

RF

-4.5 (13.8)

 

-2.1 (3.9)b

1.2 (1.6)b

 

Sham

-1.8 (11.5)

 

-1.0 (3.1)

0.4 (2.0)

 

Effect size

0.34

 

0.50

0.66

No significant differences after 1 wk 

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Scale (maximum of 24); FOSQ: Functional Outcomes of Sleep Questionnaire; MCS: Mental Component Summary score; PCS: Physical Component Summary score; SD: standard deviation; SF-36: 36-Item Short-Form Health Survey.
a The compound end point scored added points derived from AHI, ESS, SF-36 PCS, and SF-36 MCS;
b p=0.005 for baseline to posttreatment.

Tables 11 and 12 display notable gaps identified in each study.

Table 11. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Black et al (2009)8,

4. Included patients with mild OSA and snoring

4. Single treatment with RFA

 

 

 

Woodson et al (2003)9,

 

 

 

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
OSA: obstructive sleep apnea; RFA: radiofrequency ablation.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 12. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Black et al (2009)8,

 

2. Surgeons also performed follow-up assessments

 

 

 

.

Woodson et al (2003)9,

 

 

 

 

 

3. Comparative treatment effects not reported

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Radiofrequency Volumetric Reduction of Palatal Tissues and Base of Tongue
The evidence on RF volume reduction includes 2 randomized trials, both sham-controlled. Single-stage RF to palatal tissues did not improve outcomes compared with sham. Multiple sessions of RF to the palate and base of tongue did not significantly (statistically or clinically) improve AHI, while the improvement in functional outcomes did not achieve a level of clinical significance.

Palatal Stiffening Procedures
Palatal stiffening procedures include insertion of palatal implants, injection of a sclerosing agent (snoreplasty), or a cautery-assisted palatal stiffening operation. Snoreplasty and cautery-assisted palatal stiffening operation are intended for snoring, and are not discussed here. Palatal implants are cylindrically shaped devices that are implanted in the soft palate.

Randomized Controlled Trials
Two double-blind, sham-controlled randomized trials with over 50 patients have evaluated the efficacy of palatal implants to improve snoring and OSA (see Table 13). AHI success by the Sher criteria ranged from 26% to 45% at 3-month follow-up. AHI success was observed in 0% to 10% of the sham control patients (see Table 14). In 1 study (Steward et al [2008]), the statistical significance of AHI success was marginal and there was no statistical difference in snoring or change in ESS between the 2 groups.10, In the study by Friedman et al (2008), there was greater success in AHI (45% vs 0%, p<0.001), improvement in snoring (-4.7 vs -0.7 on a 10-point VAS, p<0.001), and improvement in ESS (-2.4 vs -0.5, p<0.001) with palatal implants compared with sham controls.5, Patient selection criteria were different in the 2 studies. In the trial by Friedman et al (2008), patients with a Friedman tongue position of IV and palate of 3.5 cm or longer were excluded, whereas, in the trial by Steward et al (2008), selection criteria included patients with primarily retropalatal pharyngeal obstruction.

Table 13. Summary of Key Randomized Controlled Trial Characteristics

Study

Countries

Sites

Participants

Interventions

 

 

 

 

Active

Comparator

Steward et al (2008)10,

U.S.

3

100 patients with mild-to-moderate OSA (AHI ≥5 and ≤40), and primarily retropalatal pharyngeal obstruction, BMI ≤32 kg/m2

50 received the office-based insertion of 3 palatal implants

50 received the sham procedure

Friedman et al (2008)5,

U.S.

1

62 patients with mild-to-moderate OSA (AHI ≥5 and ≤40), soft palate ≥2 cm and <3.5 cm, Friedman tongue position I, II, or III, BMI ≤32 kg/m2

31 received the office-based insertion of 3 palatal implants

31 received the sham procedure

AHI: Apnea/Hypopnea Index, BMI: body mass index; OSA: obstructive sleep apnea.

Table 14. Summary of Key Randomized Controlled Trial Results

Study

AHI Success (Sher criteria)

Snoring (10- point VAS)

Change in ESS (95% CI) or (SD)

Change in FOSQ Score (95% CI)

Foreign Body Sensation/Extrusion

Steward et al (2008)10,

 

 

 

 

 

N

97

43

96

98

100

Palatal implants

26%

6.7

-1.8 (-0.8 to -2.9)

1.43 (0.84 to 2.03)

18%/4 extruded

Sham control

10%

7.0

-1.5 (-.04 to -2.5)

0.6 (0.01 to 1.20)

2%

p

0.04

0.052

NS

0.05

 

Friedman et al (2008)5.

 

Change in VAS

 

 

 

N

55

62

62

 

 

Palatal implants (SD)

44.8%

-4.7 (2.1)

-2.4 (2.2)

 

2 extruded

Sham control (SD)

0%

-0.7 (0.9)

-0.5 (1.5)

 

 

MD (95% CI)

 

4.0 (3.2 to 4.9)

1.9 (1.0 to 2.9)

 

 

p

<0.001

< 0.001

<0.001

 

 

Summary: Range

26%-44.8%

 

 

 

 

CI: confidence interval; ESS: Epworth Sleepiness Score; MD: mean difference; NS: not significant; RCT: randomized controlled trial; RR: relative risk; SD: standard deviation; VAS: visual analog scale.

Case Series
Uncontrolled series have provided longer follow-up data on patients treated with palatal implants. Using criteria of 50% improvement in AHI and final AHI of less than 10 events hour, Neruntarat et al (2011) reported a success rate of 52% at a minimum of 24 months (see Tables 15 and 16). Compared with nonresponders, responders had lower body mass index, lower baseline AHI and a lower percentage of patients with a modified Mallampati classification of III or IV (obscured visualization of the soft palate by the tongue). Tables 17 and 18 summarize the limitations of the studies described above.

Table 15. Summary of Key Case Series Characteristics

Study

Country

Participants

Follow-Up

Neruntarat et al (2011)11,

Thailand

92 patients with mild-to-moderate symptomatic OSA and palate >2 cm

Minimum 24 mo

OSA: obstructive sleep apnea.

Table 16. Summary of Key Case Series Results 

Study

N

AHI (SD)

Snoring (SD) (10-point VAS)

ESS (SD)

Implant Extrusion

Neruntarat et al (2011)11,

92

 

 

 

 

Baseline

 

21.7 (6.8)

8.2 (1.2)

12.3 (2.6)

 

29 months

 

10.8 (4.8)

3.8 (2.3)

7.9 (1.8)

7 (7.6%)

p

 

<0.001

<0.001

<0.001

 

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Score; SD: standard deviation; VAS: visual analog scale.

Table 17. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Neruntarat et al (2011) 11,

 

 

2. No comparator

 

 

Steward et al (2008)10,

 

 

 

 

1, 2. 3 mo

Friedman et al (2008)5

 

 

 

 

1, 2. 3 mo

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms. 

Table 18. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Neruntarat et al (2011)11,

1.Retrospective

1.None (case series)

 

 

 

 

Steward et al (2008)10,

 

 

 

 

 

 

Friedman et al (2008)5

 

 

 

 

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Palatal Stiffening Procedures
Two sham-controlled trials have assessed palatal implants for the treatment of snoring and OSA. The studies differed in the inclusion criteria, with the study that excluded patients with Friedman tongue position of IV and palate of 3.5 cm or longer reporting greater improvement in AHI (45% success) and snoring (change of -4.7 on a 10-point VAS) than the second trial.

Tongue BaSE Suspension
In this procedure, the base of the tongue is suspended with a suture that is passed through the tongue and fixated with a screw to the inner side of the mandible, below the tooth roots. The aim of the suspension is to make it less likely for the base of the tongue to prolapse during sleep.

One preliminary RCT with 17 patients was identified that compared UPPP plus tongue suspension with UPPP plus tongue advancement (see Table 19).12, Success rates using the Sher criteria ranged from 50% to 57% (see Table 20). Both treatments improved snoring and reduced ESS to below 10. The major limitations of the trial were the number of subjects (n=17) in this feasibility study and the lack of blinding (see Tables 21 and 22). In addition, there was no follow-up after 16 weeks.

Table 19. Summary of Key Randomized Controlled Trial Characteristics

Study

Countries

Sites

Participants

Interventions

 

 

 

 

Active

Comparator

Thomas et al (2003)12,

U.S.

1

17 patients with moderate-to-severe OSA who failed conservative treatment

  • UPPP with tongue suspension
  • Mean AHI=46 (n=9)
  • UPPP with tongue advancement
  • Mean AHI=37.4 (n=8)

AHI: Apnea/Hypopnea Index; OSA: obstructive sleep apnea; UPPP:uvulopalatopharyngoplasty.

Table 20. Summary of Key Randomized Controlled Trial Results 

Study

AHI Success 
(Sher Criteria)

Snoring (SD)

ESS (SD)

Pain, Speech, Swallowing

Thomas et al (2003)12,

 

 

 

 

N

11

17

17

17

UPPP plus tongue suspension

57%

3.3 (2.1)a

4.1 (3.4)b

 

UPPP plus tongue advancement

50%

5.0 (0.6)c

5.4 (3.5)d

No significant differences between groups

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Score; SD: standard deviation; UPPP:uvulopalatopharyngoplasty.
a
 Baseline to posttreatment p=0.02.

b Baseline to posttreatment p=0.007.
c Baseline to posttreatment p=0.04.
d Baseline to posttreatmentp=0.004.

Table 21. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Thomas et al (2003)12,

 

 

 

 

1, 2. Follow-up was to 16 wk

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 22. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Thomas et al (2003)12,

3. Allocation concealment unclear

1.-3. Not blinded

 

 

1. Feasibility study

4. Comparative treatment effects not calculated

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Tongue Base Suspension
One feasibility study with 17 patients was identified on tongue suspension. This study compared tongue suspension plus UPPP with tongue advancement plus UPPP and reported 50% to 57% success rates for the 2 procedures. RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to UPPP improves the net health outcome.

Hypoglossal Nerve Stimulation
Stimulation of the hypoglossal nerve causes tongue protrusion and stiffening of the anterior pharyngeal wall, potentially decreasing apneic events. For patients with moderate-to-severe sleep apnea who have failed or are intolerant of CPAP, the alternative would be an established surgical procedure, as described above.

Comparative Studies
No RCTs have been identified on HNS. Comparative evidence consists of 2 studies that compared HNS with historical controls treated with UPPP or a variant of UPPP (expansion sphincter pharyngoplasty, see Table 23). AHI success by the Sher criteria ranged from 87% to 100% in the HNS group compared with 40% to 64% in the UPPP group (see Table 24). Posttreatment ESS was below 10 in both groups. It is not clear from these studies whether the patients in the historical control group were similar to the subset of patients in the HNS group, particularly in regards to the pattern of palatal collapse and from patients who did not return for postoperative PSG (see Tables 25 and 26). UPPP may not be the most appropriate comparator for HNS, because UPPP is less effective for patients with obstruction arising primarily from the tongue base (the primary target for HNS).

Table 23. Summary of Observational Comparative Study Characteristics

Study

Study Type

Country

Dates

Participants

HNS

Traditional Surgery

Follow-Up

Shah et al (2018)13,

Retrospective series with historical controls

U.S.

  • HNS 2015- 2016
  • UPPP 2003-2012

40 OSA patients with AHI >20 and <65, BMI ≤32 kg mg/m2, failed CPAP, favorable pattern of palatal collapsea

35% had previously had surgery for OSA

UPPP 50% of patients had additional surgical procedures

2-13 mo

Huntley et al (2018)14,

Retrospective series with historical controls

U.S.

  • HNS 2014- 2016
  • Modified UPPP 2011-2016

Retrospective review included treated patients who had a postoperative PSG

75 patients age 61.67 y with a favorable pattern of palatal collapse

33 patients age 43.48 y treated by ESP

To post-operative PSG

BMI: body mass index; CPAP: continuous positive airway pressure; ESP: expansion sphincter pharyngoplasty; HNS: hypoglossal nerve stimulation; OSA: obstructive sleep apnea; PSG: polysomnography; UPPP: uvulopalatopharyngoplasty.
A favorable pattern of palatal collapse is not concentric retropalatal obstruction on drug-induced sleep endoscopy.

Table 24. Summary of Key Observational Comparative Study Results

Study

Baseline AHI (SD)

Posttreatment AHI (SD)

AHI Success (%) Sher Criteria

Baseline ESS (SD)

Posttreatment ESS (SD)

Shah et al (2018)13,

 

 

 

 

 

HNS

38.9 (12.5)

4.5 (4.8)b

20 (100%)

13 (4.7)

8 (5.0)b

UPPP

40.3 (12.4)

28.8 (25.4)a

8 (40%)

11 (4.9)

7 (3.4)b

Huntley et al (2018)14,

 

 

 

 

 

HNS

36.8 (20.7)

7.3 (11.2)

86.7

11.2 (4.2)

5.4 (3.4)

ESP

26.7 (20.3)

13.5 (19.0)

63.6

10.7 (4.5)

7.0 (6.0)

p

0.003

0.003

0.008

0.565

NS

AHI: Apnea/Hypopnea Index; ESP: expansion sphincter pharyngoplasty; HNS: hypoglossal nerve stimulation; NS: not significant; Sher criteria: 50% decrease in AHI and final AHI <20; SD; standard deviation; UPPP: uvulopalatopharyngoplasty.
a Baseline vs posttreatment p<0.05.
b Baseline vs posttreatment p<0.001.

Table 25. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Shah et al (2018)13,

 

 

2. UPPP may not be preferred treatment for patients with primarily lingual obstruction

 

 

Huntley et al (2018)14,

4. Study populations not comparable

 

1. Not clearly defined, few ESP patients had follow-up PSG

 

 

Steffen et al (2018)15,

 

 

2.No comparator

 

 

STAR trial16-21,

 

 

2.No comparator

 

 

AHI: Apnea/Hypopnea Index; ESP: expansion sphincter pharyngoplasty; HNS: hypoglossal nerve stimulation; NS: not significant; Sher criteria: 50% decrease in AHI and final AHI <20; SD; standard deviation; UPPP: uvulopalatopharyngoplasty.
a Baseline vs posttreatment p<0.05.
b Baseline vs posttreatment p<0.001.

Table 25. Relevance Gaps 

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Shah et al (2018)13,

 

 

2. UPPP may not be preferred treatment for patients with primarily lingual obstruction

 

 

Huntley et al (2018)14,

4. Study populations not comparable

 

1. Not clearly defined, few ESP patients had follow-up PSG

 

 

Steffen et al (2018)15,

 

 

2.No comparator

 

 

STAR trial16 -21,

 

 

2.No comparator

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
ESP: expansion sphincter pharyngoplasty; PSG: polysomnography; STAR: Stimulation Therapy for Apnea Reduction; UPPP: uvulopalatopharyngoplasty.
Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 26. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingd

Data Completenesse

Powerd

Statisticalf

Shah et al (2018)13,

1. Not randomized (retrospective)

4. Inadequate control for selection bias

1.-3. No blinding

 

 

 

4. Comparative treatment effects not calculated

 

Huntley et al (2018)14,

1. Not randomized (retrospective)

1.-3. No blinding

 

 

 

 

Steffen et al (2018)15,

1. Not randomized

1.-3. No blinding

 

 

 

 

STAR trial16-21,

1. Not randomized

1.-3. No blinding

 

 

 

 

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
STAR: Stimulation Therapy for Apnea Reduction.
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Single-Arm Studies
Results of prospective single-arm studies show success rates in 66% to 68% of patients who had moderate-to-severe sleep apnea and a favorable pattern of palatal collapse (see Tables 27 and 28). Mean AHI was 31 to 32 at baseline, decreasing to 14 to 15 at 12 months. ESS scores decreased to 6.5 to 7.0. All improvements were maintained through 5 years of follow-up. Discomfort due to the electrical stimulation and tongue abrasion were initially common, but were decreased when stimulation levels were reduced (see Table 29).

Table 27. Summary of Prospective Single-Arm Study Characteristics

Study

Country

Participants

Treatment Delivery

Follow-Up

STAR trial16-21,

EU, U.S.

126 patients with AHI >20 and <50, BMI ≤32 kg/m2, failed CPAP, favorable pattern of palatal collapsea

Stimulation parameters titrated with full PSG

5 y

Postmarket studies: Heiser et al (2017)22,

Steffen et al (2018)15,

3 sites in Germany

60 patients with AHI ≥15 and ≤65 on home sleep study, BMI ≤35 kg/m2, failed CPAP; favorable pattern of palatal collapsea

 

12 mo

AHI: apnea/hypopnea index; BMI: body mass index; CPAP: continuous positive airway pressure; STAR: Stimulation Therapy for Apnea Reduction.
A favorable pattern of palatal collapse is non-concentric retropalatal obstruction on drug-induced sleep endoscopy. 

Table 28. Summary ofProspective Single-Arm Study Results

Study

N

Percent of Patients With AHI Success (Sher criteria)

Mean AHI Score (SD)

Mean ODI Score (SD)

FOSQ Score (SD)

ESS Score (SD)

STAR trial16-21,

 

 

 

 

 

 

Baseline

126

 

32.0 (11.8)

28.9 (12.0)

14.3 (3.2)

11.6 (5.0)

12 months

124

66%

15.3 (16.1)d

13.9 (15.7)d

17.3 (2.9)d

7.0 (4.2)d

3 years

116a

65%

14.2 (15.9)

9.1 (11.7)

17.4 (3.5)b

7.0 (5.0)b

5 years

97c

63%

12.4 (16.3)

9.9 (14.5)

18.0 (2.2)

6.9 (4.7)

Postmarket studies: Heiser et al (2017)22,

Steffen et al (2018)15,

 

 

 

 

 

 

Baseline

60

 

31.2 (13.2)

27.6 (16.4)

13.7 (3.6)

12.8 (5.3)

12 months

56f

68%

13.8 (14.8)e

13.7 (14.9)e

17.5 (3)e

6.5 (4.5)e

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Scale; FOSQ: Functional Outcomes of Sleep Questionnaire; ODI: Oxygen Desaturation Index; PSG: polysomnography; SD: standard deviation; STAR: Stimulation Therapy for Apnea Reduction.
Ninety-eight participants agreed to undergo PSG at 36 months, of the 17 participants who did not undergo PSG at 36 months, 54% were nonresponders and their PSG results at 12 or 18 months were carried forward.
The change from baseline was significant at p<0.001.
Seventy-one participants agreed to a PSG.
f Four patients lost to follow-up were analyzed as treatment failures.
d p<0.001.
e p< 0.05.

Table 29. Device-Related Adverse Events From Prospective Single-Arm Studies

Study

N

Discomfort due to Electrical Stimulationa

Tongue Abrasion

Dry Mouth

Mechanical Pain From Device

Internal Device Usability

External Device Usability

STAR trial21,

 

 

 

 

 

 

 

0 to 12 months

126

81

28

10

7

12

11

12 to 24 months

124

23

12

5

2

8

11

24 to 36 months

116

26

4

2

3

1

8

36 to 48 months

97

7

3

0

1

3

9

> 48 months

 

5

3

3

1

1

6

Participants with event, n of 126 (%)

 

76 (60.3)

34 (27.0)

19 (15.1)

14 (11.1)

21 (16.7)

33 (26.2)

STAR: Stimulation Therapy for Apnea Reduction.
Stimulation levels were adjusted to reduce discomfort

Section Summary: Hypoglossal Nerve Stimulation
The evidence on HNS for the treatment of OSA includes nonrandomized studies with historical controls and prospective single-arm studies. For patients with moderate-to-severe OSA who had failed conservative therapy (CPAP) and had a favorable pattern of palatal collapse, about two-thirds met the study definition of success. Results observed at the 12-month follow-up were maintained at 5 years in the pivotal study. Clinical input supplements and informs the interpretation of the published evidence. Clinical input indicates that HNS leads to a meaningful improvement in health outcomes in appropriately selected adult patients with a favorable pattern of non-concentric palatal collapse. The alternative treatment for this anatomical endotype is maxillo-mandibular advancement (MMA), which is associated with greater morbidity and lower patient acceptance than HNS. The improvement in AHI with HNS, as shown in the STAR trial, is similar to the improvement in AHI following MMA.  Clinical input also supports that HNS results in a meaningful improvement in health outcomes in appropriately selected adolescents with OSA and Down’s syndrome who have difficulty in using CPAP. Further details from clinical input are included in the Clinical Input section later in the review and the Appendix.

Summary of Evidence
The following conclusions are based on a review of the evidence, including, but not limited to, published evidence and clinical expert opinion, via BCBSA’s Clinical Input Process.

For individuals who have OSA who receive laser-assisted uvulopalatoplasty, the evidence includes a single randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The trial indicates reductions in snoring, but limited efficacy on the Apnea/Hypopnea Index (AHI) or symptoms in patients with mild-to-moderate OSA. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive a radiofrequency volumetric reduction of palatal tissues and base of tongue, the evidence includes 2 sham-controlled randomized trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Single-stage radiofrequency to palatal tissues did not improve outcomes compared with sham. Multiple sessions of radiofrequency to the palate and base of tongue did not significantly (statistically or clinically) improve AHI, and the improvement in functional outcomes was not clinically significant. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive palatal stiffening procedures, the evidence includes two sham-controlled randomized trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The 2 RCTs differed in their inclusion criteria, with the study that excluded patients with Friedman tongue position of IV and palate of 3.5 cm or longer reporting greater improvement in AHI (45% success) and snoring (change of -4.7 on a 10-point visual analog scale) than the second trial. Additional study is needed to corroborate the results of the more successful trial and, if successful, define the appropriate selection criteria. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive tongue base suspension, the evidence includes a feasibility RCT with 17 patients. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT compared tongue suspension plus uvulopalatopharyngoplasty with tongue advancement plus uvulopalatopharyngoplasty and showed success rates of 50% to 57% for both procedures. RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to uvulopalatopharyngoplasty improves the net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive hypoglossal nerve stimulation, the evidence includes two nonrandomized studies with historical controls and prospective single-arm studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Hypoglossal nerve stimulation has shown success rates for about two-thirds of a subset of patients who met selection criteria that included AHI, body mass index, and favorable pattern of palatal collapse. These results were maintained out to five years in the pivotal single-arm study. Clinical input supplements and informs the interpretation of the published evidence. Clinical input indicates that HNS leads to a meaningful improvement in health outcomes in appropriately selected adult patients with a favorable pattern of non-concentric palatal collapse. The alternative treatment for this anatomical endotype is maxillo-mandibular advancement (MMA), which is associated with greater morbidity and lower patient acceptance than HNS. The improvement in AHI with HNS, as shown in the STAR trial, is similar to the improvement in AHI following MMA.  Clinical input also supports that HNS results in a meaningful improvement in health outcomes in appropriately selected adolescents with OSA and Down’s syndrome who have difficulty in using CPAP. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome for patients meeting the following selection criteria which are based on information from clinical study populations and clinical expert opinion.

  • Age ≥ 22 years in adults or adolescents with Down’s syndrome age 10 to 21; AND
  • Diagnosed moderate to severe OSA (with less than 25% central apneas); AND
  • CPAP failure or inability to tolerate CPAP; AND
  • Body mass index ≤ 35 kg/min adults; AND
  • Favorable pattern of palatal collapse

Clinical Input
Objective
In 2018, clinical input was sought to help determine whether the use of hypoglossal nerve stimulation for individuals with obstructive sleep apnea would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice.

Respondents
Clinical input was provided by the following specialty societies and physician members identified by a specialty society or clinical health system:

  • American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS)
  • Anonymous, MD, Otolaryngology, identified by American Academy of Pediatrics (AAP)a

a Indicates that conflicts of interest related to the topic where clinical input is being sought were identified by this respondent.

Clinical input provided by the specialty society at an aggregate level is attributed to the specialty society. Clinical input provided by a physician member designated by a specialty society or health system is attributed to the individual physician and is not a statement from the specialty society or health system. Specialty society and physician respondents participating in the Evidence Street® clinical input process provide review, input, and feedback on topics being evaluated by Evidence Street. However, participation in the clinical input process by a specialty society and/or physician member designated by a specialty society or health system does not imply an endorsement or explicit agreement with the Evidence Opinion published by BCBSA or any Blue Plan.

Clinical Input Responses 
** Indicates that conflicts of interest related to the topic where clinical input is being sought were identified by this respondent.

Additional Comments

  • “The only HNS to achieve FDA approval achieved this status in 2014. Since that time, thousands of patients have undergone treatment of this device and dozens of publications have shown clinically meaningful benefit in both polysomnographic (PSG) parameters and quality of life indices. There is no question that this technology is no longer investigational and has the potential to benefit patients unable to tolerate conservative therapy and mitigate health risks associated with obstructive sleep apnea (OSA).

The current CMS indications for HNS include adult patients (greater than 22 years old), with moderate to severe OSA (AHI between 15-65), whose central apnea index is less than 25% the overall AHI, with BMI less than 32, who have been unable to tolerate conservative therapy with positive pressure ventilation, and have specific anatomic findings on sedated endoscopy. The Stimulation Therapy for Apnea Reduction trial (STAR) was published in 2014 in the New England Journal of Medicine. This study, and its follow up publications, showed significant improvement in PSG indices of apnea hypopnea index (AHI) and oxygen desaturation nadir (nadir) along with quality of life improvement after one year of use. The findings were confirmed with the withdrawal cohort of the original STAR trail and have shown lasting benefit through five years of use with follow up publication.

It is becoming increasingly well recognized that OSA does not represent a single phenotype or more accurately stated, endotype. Anatomic endotypes certainly exist with sub-populations of patients with craniofacial abnormalities, obesity, soft tissue hypertrophy and/or redundancy treated appropriately with conventional surgery. However, we are now understanding that ineffective upper airway dilator muscles (genioglossus muscle supplied by the hypoglossal nerve) are a key contributor to OSA pathogenesis (Subramani et al, Anesth Analg 2017; 124:179-91, PMID - 27861433). This requires a treatment targeted to that pathology.” (AAO-HNS)

  • “There is now a substantial body of evidence that describes the safety and efficacy of hypoglossal nerve stimulator in adults with moderate to severe sleep apnea that have failed CPAP. Most recently 5 year follow-up data was published demonstrating sustained improvement in PSG parameters such as AHI, QOL measures, and daytime sleepiness following hypoglossal nerve stimulator utilization. The criteria for adults with OSA that would benefit from hypoglossal nerve stimulation have been well established and include: 1) 22 years of age and older; 2) Diagnosed OSA with an AHI range of 15-65 per hour (Less 25% Central Apneas); 3) CPAP failure or inability to tolerate CPAP treatment; 4) Appropriate airway anatomy on Drug Induced Sleep Endoscopy; 5) BMI < 32. (Woodson BT, Strohl KP, Soose RJ, et al. Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes. Otolaryngol Head Neck Surg. Jul 2018;159(1):194-202. PMID: 29582703)” (Anonymous, Otolaryngology, identified by AAP)
  • “Recent data has also emerged on the efficacy and safety of hypoglossal nerve simulator therapy in children with Down Syndrome that have persistent severe OSA following T&A. The inclusion criteria for these children is as follows: 1) Adolescents with Down syndrome age 10 to 21 years with prior T&A; 2) BMI < 95th percentile; 3) Severe OSA with AHI between 10 and 50 (< 25% central events); 4) Unable to tolerate CPAP or tracheostomy dependent at night; 5) need for future head MRI. Children with Down Syndrome that have persistent OSA after adenotonsillectomy are very difficult to treat. They often are unable to tolerate cpap and outside of a tracheostomy there were limited options available to cure their obstruction outside of the hypoglossal nerve stimulator. (Diercks GR, Wentland C, Keamy D, et al. Hypoglossal Nerve Stimulation in Adolescents With Down Syndrome and Obstructive Sleep Apnea. JAMA Otolaryngol Head Neck Surg. Nov 2 2017. PMID: 29098288)” (Anonymous, Otolaryngology, identified by AAP)

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2018 Input
In response to requests, clinical input on moderate-to-severe and mild obstructive sleep apnea was received from 2 respondents, including 1 specialty society-level response and physicians with academic medical center affiliation, while this policy was under review in 2018.

Based on the evidence and independent clinical input, the clinical input supports that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice:

  • Use of hypoglossal nerve stimulation for individuals with moderate-to-severe obstructive sleep apnea who have failed an adequate trial of (or are unable to tolerate) continuous positive airway pressure.

Based on the evidence and independent clinical input, the clinical input does not support that the following indication provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice:

  • Use of hypoglossal nerve stimulation for individuals with mild obstructive sleep apnea who have failed an adequate trial of (or are unable to tolerate) continuous positive airway pressure.

Practice Guidelines and Position Statements
American Academy of Sleep Medicine
The American Academy of Sleep Medicine (2010) published practice parameters for surgical modifications of the upper airway for obstructive sleep apnea (OSA).4, The AASM practice parameters were based on a systematic review of the evidence that foundthe published literature was comprised primarily of case series, with few controlled trials and varying approaches to preoperative evaluation and postoperative follow-up.23, Using the change in Apnea/Hypopnea Index as the primary measure of efficacy, substantial and consistent reductions were observed following mandibular-maxillary advancement, and adverse events were uncommonly reported. Outcomes following pharyngeal surgeries were less consistent, and adverse events were more commonly reported. The review found that outcomes of studies with newer pharyngeal techniques and multilevel procedures, performed in small numbers of patients, appear promising. The practice parameters noted the lack of rigorous data evaluating surgical modifications of the upper airway, resulting in a recommendation of “option” (uncertain clinical use) for mandibular-maxillary advancement, uvulopalatopharyngoplasty as a sole procedure, or multilevel or stepwise surgery if patients failed uvulopalatopharyngoplasty as a sole treatment. Use of radiofrequency ablation was recommended as an “option” for patients with mild-to-moderate OSA who cannot tolerate or are unwilling to adhere to continuous positive airway pressure (CPAP), or in whom oral appliances have been found ineffective or undesirable. Palatal implants were recommended as an “option” for patients with mild OSA who failed medical therapy. Laser-assisted uvulopalatoplasty was not recommended as a routine treatment for OSA (standard). The practice parameters recommended as “standard” the need to determine the presence and severity of OSA before initiating surgical therapy, discussion of success rates, complications, and alternative treatments with the patient, and a postoperative follow-up evaluation, which includes a clinical evaluation and an objective measure of the presence and severity of sleep-disordered breathing and oxygen saturation. However, little guidance was available in the medical literature to recommend any particular monitoring strategy. The optimal interval and duration of this follow-up were also not clear from the available literature.

American Academy of Pediatrics
The American Academy of Pediatrics (2012) published a clinical practice guideline on the diagnosis and management of childhood OSA.24, The Academy indicated that if a child has OSA, a clinical examination consistent with adenotonsillar hypertrophy, and does not have a contraindication to surgery, the clinician should recommend adenotonsillectomy as first-line treatment. The Academy recommended that patients should be referred for CPAP management if symptoms/signs or objective evidence of OAS persist after adenotonsillectomy or if adenotonsillectomy is not performed. Weight loss was recommended in addition to other therapy if a child or adolescent with OSA is overweight or obese.

American Academy of Otolaryngology - Head and Neck Surgery
The American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS; 2014) has arevised position statement on surgical management of OSA.25, Procedures AAO-HNS supported as effective and not considered investigational when part of a comprehensive approach in the medical and surgical management of adults with OSA include:

  • tracheotomy,
  • nasal and pharyngeal airway surgery,
  • tonsillectomy and adenoidectomy,
  • palatal advancement,
  • uvulopalatopharyngoplasty,
  • uvulopalatoplasty (including laser-assisted and other techniques),
  • genioglossal advancement,
  • hyoid myotomy,
  • midline glossectomy,
  • tongue suspension,
  • maxillary and mandibular advancement.

In a position statement, AAO-HNS (2016) supported hypoglossal nerve stimulation as an effective second-line treatment of moderate-to-severe OSA in patients who are intolerant or unable to achieve benefit with CPAP.26, AAO-HNS noted that not all patients are candidates for upper airway stimulation therapy and require a number of assessments to ensure proper patient selection.

American Society for Metabolic and Bariatric Surgery
The American Society for Metabolic and Bariatric Surgery (2012) published guidelines on the perioperative management of OSA.27, The guideline indicated that OSA is strongly associated with obesity, with the incidence of OSA in the morbidly obese population reported as between 38% and 88%. The Society recommended bariatric surgery as the initial treatment of choice for OSA in this population, as opposed to surgical procedures directed at the mandible or tissues of the palate.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 30.

Table 30. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

 

 

 

NCT02344108a

A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea

50

Sep 2020

NCT02907398a

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

2,500

Sep 2019

NCT03359096

Cardiovascular Endpoints for Obstructive Sleep Apnea With Twelfth Nerve Stimulation (CARDIOSA-12): A Randomized, Sham-Controlled, Double-Blinded, Crossover Trial

80

Jun 2020

NCT02413970a

Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001

127

Dec 2021

NCT02263859a

ImThera Medical Targeted Hypoglossal Neurostimulation Study #3 (THN3)

141

Dec 2022

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References:

  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Surgical management of sleep apnea. TEC Assessments. 1995;Volume 10:Tab 32.
  2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Radiofrequency volumetric tissue reduction for sleep-related breathing disorders. TEC Assessments. 2000; Volume 15:Tab 15.
  3. Friedman M, Salapatas AM, Bonzelaar LB. Updated Friedman Staging System for Obstructive Sleep Apnea. Adv Otorhinolaryngol. 2017;80:41-48. PMID 28738388
  4. Aurora RN, Casey KR, Kristo D, et al. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. Oct 1 2010;33(10):1408-1413. PMID 21061864
  5. Friedman M, Schalch P, Lin HC, et al. Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. Feb 2008;138(2):209-216. PMID 18241718
  6. Lee LA, Yu JF, Lo YL, et al. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial. PLoS One. May 2014;9(5):e97186. PMID 24816691
  7. Ferguson KA, Heighway K, Ruby RR. A randomized trial of laser-assisted uvulopalatoplasty in the treatment of mild obstructive sleep apnea. Am J Respir Crit Care Med. Jan 1 2003;167(1):15-19. PMID 12502473
  8. Back LJ, Liukko T, Rantanen I, et al. Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single-stage procedure: A randomized single-blinded placebo-controlled trial. Laryngoscope. Aug 2009;119(8):1621-1627. PMID 19504550
  9. Woodson BT, Steward DL, Weaver EM, et al. A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. Jun 2003;128(6):848-861. PMID 12825037
  10. Steward DL, Huntley TC, Woodson BT, et al. Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study. Otolaryngol Head Neck Surg. Oct 2008;139(4):506-510. PMID 18922335
  11. Neruntarat C. Long-term results of palatal implants for obstructive sleep apnea. Eur Arch Otorhinolaryngol. Jul 2011;268(7):1077-1080. PMID 21298386
  12. Thomas AJ, Chavoya M, Terris DJ. Preliminary findings from a prospective, randomized trial of two tongue-base surgeries for sleep-disordered breathing. Otolaryngol Head Neck Surg. Nov 2003;129(5):539-546. PMID 14595277 
  13. Shah J, Russell JO, Waters T, et al. Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience. Am J Otolaryngol. May - Jun 2018;39(3):266-270. PMID 29540289
  14. Huntley C, Chou DW, Doghramji K, et al. Comparing upper airway stimulation to expansion sphincter pharyngoplasty: a single university experience. Ann Otol Rhinol Laryngol. Jun 2018;127(6):379-383. PMID 29707958
  15. Steffen A, Sommer JU, Hofauer B, et al. Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. Laryngoscope. Feb 2018;128(2):509-515. PMID 28561345
  16. Strollo PJ, Jr., Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. Jan 9 2014;370(2):139-149. PMID 24401051
  17. Strollo PJ, Jr., Gillespie MB, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep. Oct 1 2015;38(10):1593-1598. PMID 26158895
  18. Woodson BT, Soose RJ, Gillespie MB, et al. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR Trial. Otolaryngol Head Neck Surg. Jan 2016;154(1):181-188. PMID 26577774
  19. Soose RJ, Woodson BT, Gillespie MB, et al. Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. J Clin Sleep Med. Jan 2016;12(1):43-48. PMID 26235158
  20. Gillespie MB, Soose RJ, Woodson BT, et al. Upper airway stimulation for obstructive sleep apnea: patient-reported outcomes after 48 months of follow-up. Otolaryngol Head Neck Surg. Apr 2017;156(4):765-771. PMID 28194999
  21. Woodson BT, Strohl KP, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: 5-year outcomes. Otolaryngol Head Neck Surg. Mar 1 2018:194599818762383. PMID 29582703
  22. Heiser C, Maurer JT, Hofauer B, et al. Outcomes of upper airway stimulation for obstructive sleep apnea in a multicenter German postmarket study. Otolaryngol Head Neck Surg. Feb 2017;156(2):378-384. PMID 28025918
  23. Caples SM, Rowley JA, Prinsell JR, et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: a systematic review and meta-analysis. Sleep. Oct 1 2010;33(10):1396-1407. PMID 21061863
  24. Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. Sep 2012;130(3):e714-755. PMID 22926176
  25. American Academy of Otolaryngology - Head and Neck Surgery. Surgical Management of Obstructive Sleep Apnea. 2014; http://www.entnet.org/Practice/policySurgicalMgmtApnea.cfm. Accessed May 22, 2018.
  26. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (OSA). 2016; http://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa. Accessed May 22, 2018.
  27. Clinical Issues Committee, American Society for Metabolic & Bariatric Surgery. Peri-operative management of obstructive sleep apnea. 2012; https://asmbs.org/resources/peri-operative-management-of-obstructive-sleep-apnea. Accessed May 22, 2018.
  28. Centers for Medicare & Medicaid Services. Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2). 2008; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=204 Accessed November 6, 2018.

Coding Section

Codes Number Description
 CPT

21199 

Osteotomy, mandible, segmental; with genioglossus advancement 

 

41512 

Tongue base suspension, permanent suture technique 

 

41530 

Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session 

 

42145 

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty) 

 

42299 

Unlisted procedure, palate, uvula 

 

42820-42821 

Tonsillectomy and adenoidectomy, code range 

 

42825-42826 

Tonsillectomy, primary or secondary, code range 

 

42830-42831 

Adenoidectomy, primary, code range 

 

42835-42836 

Adenoidectomy, secondary, code range

 

64568 

Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator  

 

0466T 

Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator (List separately in addition to code for primary procedure) (new code 1/1/17)  

 

0467T 

Revision or replacement of chest wall respiratory sensor electrode or electrode array, including connection to existing pulse generator (new code 1/1/17)  

 

0468T 

Removal of chest wall respiratory sensor electrode or electrode array (new code 1/1/17) 

HCPCS

S2080 

Laser-assisted uvulopalatoplasty (LAUP) 

ICD-9 Procedure 

27.64 

Insertion of palatal implant

 

27.69 

Palatoplasty 

 

27.73 

Repair of uvula 

 

29.4 

Pharyngoplasty 

ICD-9 Diagnosis 

327.23 

Obstructive sleep apnea (organic sleep apnea)

 

780.51 

Sleep apnea (with insomnia) 

 

780.53 

Sleep apnea (with hypersomnia) 

 

780.57 

Sleep apnea, unspecified type 

ICD-10-CM (effective 10/01/15

G47.30-G47.39 

Sleep apnea code range 

ICD-10-PCS (effective 10/01/15

 

ICD-10-PCS codes are only used for inpatient services. 

  0CQ20ZZ, 0CQ23ZZ, 0CQ2XZZ

Surgical, mouth & throat, repair, hard palate, code by approach (open, percutaneous, external) 

 

0CQ30ZZ, 0CQ33ZZ, 0CQ3XZZ 

Surgical, mouth & throat, repair, soft palate, code by approach (open, percutaneous, external) 

 

0CQN0ZZ, 0CQN3ZZ, 0CQNXZZ 

Surgical, mouth & throat, repair, uvula, code by approach (open, percutaneous, external) 

 

0CQM0ZZ, 0CQM3ZZ, CQM4ZZ, 0CQM7ZZ, 0CQM8ZZ 

Surgical, mouth & throat, repair, pharynx, code by approach (open, percutaneous, percutaneous endoscopic, via natural or artificial opening, via natural or artificial opening) 

 

0CR207Z, 0CR20JZ, 0CR20KZ 

Surgical, mouth & throat, replacement, hard palate, open, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute) 

 

0CR237Z, 0CR23JZ, 0CR23KZ 

Surgical, mouth & throat, replacement, hard palate, percutaneous, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CR2X7Z, 0CR2XJZ, 0CR2XKZ 

Surgical, mouth & throat, replacement, hard palate, external, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute) 

 

0CR307Z, 0CR30JZ, 0CR30KZ 

Surgical, mouth & throat, replacement, soft palate, open, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CR337Z, 0CR33JZ, 0CR33KZ 

Surgical, mouth & throat, replacement, soft palate, percutaneous, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CR3X7Z, 0CR3XJZ, 0CR3XKZ 

Surgical, mouth & throat, replacement, soft palate, external, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CRM07Z, 0CRM0JZ, 0CRM0KZ 

Surgical, mouth & throat, replacement, pharynx, open, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute) 

 

0CRM7JZ, 0CRM8JZ  

Surgical, mouth & throat, replacement, pharynx, synthetic substitute, code by approach (via natural or artificial opening or via natural or artificial opening endoscopic  

 

0CS20ZZ, 0CS2XZZ 

Surgical, mouth & throat, reposition, hard palate, no device, code by approach (open, external) 

 

0CS30ZZ 

Surgical, mouth & throat, reposition, soft palate, open, no device
 

0CU207Z, 0CU20JZ, 0CU20KZ 

Surgical, mouth & throat, supplement, hard palate, open, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CU237Z, 0CU23JZ, 0CU23KZ 

Surgical, mouth & throat, supplement, hard palate, percutaneous, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CU2X7Z, 0CU2XJZ, 0CU2XKZ 

Surgical, mouth & throat, supplement, hard palate, external, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)  

 

0CU307Z, 0CU30JZ, 0CU30KZ

Surgical, mouth & throat, supplement, soft palate, open, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute)

 

0CU337Z, 0CU33JZ, 0CU33KZ 

Surgical, mouth & throat, supplement, soft palate, percutaneous, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute) 

 

0CU3X7Z, 0CU3XJZ, 0CU3XKZ 

Surgical, mouth & throat, supplement, soft palate, external, code by device (autologous tissue substitute, synthetic substitute, nonautologous tissue substitute) 

 

0CUM0JZ, 0CUM7JZ, 0CUM8JZ 

Surgical, mouth & throat, supplement, pharynx, synthetic substitute, code by approach (open, via natural or artificial opening or via natural or artificial opening endoscopic  

 

09QN0ZZ 

Medical & surgical ear, nose, sinus, repair nasopharynx open 

 

09QN3ZZ, 09QN4ZZ, 09QN7ZZ, 09QN8ZZ 

Surgical, ear, nose & sinus, repair, nasopharynx, code by approach (percutaneous, percutaneous endoscopic, via natural or artificial opening, via natural or artificial opening endoscopic)  

 

09RN0JZ 

Surgical, ear, nose & sinus, replacement nasopharynx, open, autologous tissue substitute 

 

09RN7JZ, 09RN8JZ 

Surgical, ear, nose & sinus, replacement nasopharynx, synthetic substitute, code by approach (via natural or artificial opening, via natural or artificial opening endoscopic) 

 

09UN0JZ, 09UN7JZ, 09UN8JZ 

Medical & surgical ear, nose, sinus, supplement nasopharynx, synthetic substitute, code by approach (open, via natural or artificial opening, via natural or artificial opening endoscopic) 

Type of Service 

Surgery   
Place of Service  Inpatient   

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

07/01/2019 

Annual review, no change to policy intent. All needed updating was performed during the interim review done in March 2019. 

03/18/2019 

Interim review, updating policy to allow some medical necessity criteria for hypoglossal nerve stimulation, which was previously considered investigational for all indications. Also updating description, background, rationale, references and regulatory status. 

07/17/2018 

Annual review, no change to policy intent. Updating rationale and references. 

07/13/2017 

Annual review, no change to policy intent. Policy verbiage updated in the medically necessary statement to include the variants of palatopharyngoplasty. Also updating background, description, rationale, references and coding. 

09/27/2016 

Updated the word guideline to policy when applicable. No change to policy intent. 

07/01/2016 

Annual review, no change in policy intent. 

07/27/2015 

Annual review, no change to policy intent. Updated background, description, regulatory status, rationale and references. Added coding. 

10/07/2014 

Updated investigational verbiage related to hypoglossal stimulators. Intent unchanged. New verbiage: Hypoglossal nerve nerurostimulation (e.g, the Apnex Hypoglossal Nerve Stimulation (HGNS) system, the auro6000 Neutostimulation System, ImThera's Targeted Hypoglossal Neurostimulation Therapy and Inspire® II System for Upper Airway Stimulation (UAS Therapy) investigational for the treatment of all indications, including, but not limited to, the treatment of OSA.  

07/21/2014

Annual review. Updated policy verbiage to include: "Implantable hypoglossal nerve stimulators are considered investigational for all indications, including, but not limited to, the treatment of OSA." Also updated regulatory status, rationale and references. Added related policies.

06/25/2014

 Annual review. No changes made.


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