Medical Policy

Policy Num:     07.001.022
Policy Name:  Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome
Policy ID:         [07.001.022]   [Ac / B / M+ / P+]    [7.01.101]

Last Review:       August 15, 2024
Next Review:       August 20, 2025
 

Related Policies:

  02.005.006- Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Summary

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 individuals 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 (HNS). This evidence review does not address conventional surgical procedures such as uvulopalatopharyngoplasty (UPPP), hyoid suspension, surgical modification of the tongue, maxillofacial surgery, or adenotonsillectomy.

Summary of Evidence

For individuals who have obstructive sleep apnea (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 that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive radiofrequency volumetric reduction of palatal tissues and base of tongue, the evidence includes 2 sham-controlled randomized trials and a prospective, single-arm cohort study. 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 prospective cohort study included 56 patients with mild-to-moderate OSA who received 3 sessions of office-based multilevel RFA. Results demonstrated improvement in AHI and Oxygen Desaturation Index (ODI) at the 6-month follow up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive palatal stiffening procedures, the evidence includes 2 sham-controlled randomized trials and several case series. 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 studies are needed to corroborate the results of the more successful trial and, if successful, define the appropriate selection criteria. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 UPPP with tongue advancement plus uvulopalatopharyngoplasty (UPPP) and showed success rates of 50% to 57% for both procedures. Additional RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to UPPP improves the net health outcome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive hypoglossal nerve stimulation, the evidence includes a systematic reviews, 21RCTs, nonrandomized prospective studies, nonrandomized studies with historical controls, and prospective single-arm studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A double-blind, multicenter RCT of 89 adults with moderate-to-severe OSA who did not tolerate continuous positive airway pressure (CPAP) found significant short-term improvement in AHI, Epworth Sleepiness Score (ESS), and quality of life measures with hypoglossal nerve stimulation (HNS) compared to sham stimulation. The study was limited by a short duration of follow-up and lack of diversity among included participants. Another RCT including 138 patients with moderate-to-severe OSA who did not tolerate CPAP compared outcomes for patients who received HNS therapy at 1 or 4 months after implant for the treatment and control groups, respectively. Results demonstrated significant short-term improvement in AHI and ODI when comparing HNS to no HNS at month 4. However, after 11 months of active therapy, the difference between the treatment and control groups was not statistically significant for AHI, but remained significant for ODI in favor of the treatment group. This trial was also limited by a lack of diverse individuals, as well as a lack of a true control group for long-term outcomes. Hypoglossal nerve stimulation has shown success rates for about two-thirds of a subset of patients who met selection criteria that included AHI, BMI, and favorable pattern of palatal collapse across nonrandomized trials. These results were maintained out to 5 years in the pivotal single-arm study. The single prospective comparative study of patients who received HNS versus patients who were denied insurance coverage for the procedure has a high potential for performance bias. For children and adolescents with OSA and Down Syndrome who are unable to tolerate CPAP, the evidence includes a systematic review and a prospective study of 42 individuals. The systematic review investigated HNS in adolescents with Down Syndrome and OSA, and demonstrated significant improvement in AHI and OSA-18 survey scores after HNS. The study of 42 individuals with Down Syndrome and OSA found a success rate of 73.2% with 4 device extrusions corrected with replacement surgery. Limitations of the current evidence base preclude determination of who is most likely to benefit from this invasive procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

2018 Input

Clinical input was sought to help determine whether the use of hypoglossal nerve stimulation for individuals with OSA would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 2 respondents, including 1 specialty society-level response and physicians with academic medical center affiliation.

For individuals who have OSA who receive HNS, clinical input supports this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in subgroups of appropriately selected patients. One subgroup includes 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 Stimulation Therapy for Apnea Reduction (STAR) trial, is similar to the improvement in AHI following MMA. Another subgroup includes appropriately selected adolescents with OSA and Down's syndrome who have difficulty using CPAP. The following patient selection criteria 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/m2 in adults; AND

• Favorable pattern of palatal collapse

Further details from clinical input are included in Appendix 2.

Objective

The objective of this evidence review is to determine whether the use of minimally invasive surgical procedures improve the net health outcome for patients being treated for obstructive sleep apnea.

Policy Statements

Palatopharyngoplasty (eg, 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 individuals who have:

• Apnea/Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of 15 or more events per hour, or

• AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or 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 individuals who have:

• AHI or RDI of 15 or more events per hour, or

• AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Adenotonsillectomy may be considered medically necessary in pediatric individuals with clinically significant OSA and hypertrophic tonsils. Clinically significant OSA is defined as those pediatric individuals who have:

• AHI or RDI of at least 5 per hour, or

• AHI or RDI of at least 1.5 per hour in an individual 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 ≥18 years; AND

• AHI ≥15 and ≤100 with ≤25% central apneas; AND

• CPAP failure (residual AHI ≥15 or failure to use CPAP ≥4 hr per night for ≥5 nights per week) or inability to tolerate CPAP; AND

• Body mass index ≤35 kg/m²; AND

• Absence of complete concentric collapse at the soft palate level (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 13 to 18 years ; AND

• AHI >10 and <50 with ≤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

• Absence of complete concentric collapse at the soft palate level (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 investigational for the treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical condition.

Policy Guidelines

Continuous positive airway pressure is the preferred first-line treatment for obstructive sleep apnea for most individuals. A smaller number of individuals may use oral appliances as a first-line treatment (see evidence review 8.01.67). The Apnea/Hypopnea Index is the total number of events (apnea or hypopnea) per hour of recorded sleep. The Respiratory Disturbance Index is the total number of 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% reduction in thoracoabdominal movement or airflow compared with baseline and with at least a 4% oxygen desaturation.

The hypoglossal nerve (cranial nerve XII) innervates the genioglossus muscle. Stimulation of the nerve causes anterior movement and stiffening of the tongue and dilation of the pharynx. Hypoglossal nerve stimulation reduces airway collapsibility and alleviates obstruction at both the level of the soft palate and tongue base.

Drug-induced sleep endoscopy (DISE) replicates sleep with an infusion of propofol. DISE will suggest either a flat, anterior-posterior collapse or complete circumferential oropharyngeal collapse. Concentric collapse decreases the success of hypoglossal nerve stimulation and is an exclusion criterion from the U.S. Food and Drug Administration.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Obstructive Sleep Apnea

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 individuals 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.

There are racial and ethnic health disparities seen for OSA, impacting the prevalence of disease and accessibility to treatment options, particularly affecting children. Black children are 4 to 6 times more likely to have OSA than White children.^1, Among young adults 26 years of age or younger, African American individuals are 88% more likely to have OSA compared to White individuals. Another study found that African American individuals 65 years of age and older were 2.1 times more likely to have severe OSA than White individuals of the same age group. These health disparities may affect accessibility to treatment for OSA and impact health outcomes. One analysis of insurance claims data, including over 500,000 patients with a diagnosis of OSA, found that increased age above the 18- to 29- year range (p<.001) and Black race (p=.020) were independently associated with a decreased likelihood of receiving surgery for sleep apnea.^2, Lee et al (2022) found that Black men had a continuous mortality increase specifically related to OSA over the study period (1999 to 2019; annual percentage change 2.7%; 95% confidence interval, 1.2 to 4.2) compared to any other racial group.^3,

Terminology and diagnostic criteria for OSA are shown in Table 1.

Table 1. Terminology and Definitions for Obstructive Sleep Apnea

AHI: Apnea/Hypopnea Index; APAP:auto-adjusting positive airway pressure; Bi-PAP: Bi-level positive airway pressure; CPAP: continuous positive airway pressure; EEG: electroencephalogram; OSA: obstructive sleep apnea; PAP: positive airway pressure; RDI: Respiratory Disturbance Index;REI: Respiratory Event Index; RERA: respiratory event-related arousal

Regulatory Status

The regulatory status of minimally invasive surgical interventions is shown in Table 2.

Table 2. Minimally Invasive Surgical Interventions for Obstructive Sleep Apnea

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

The expanded indication for hypoglossal nerve stimulation in patients age 18 to 21 was based on patients with Down Syndrome and is contingent on a post-approval study of the Inspire® UAS in this age group. The post-approval study will be a multicenter, single-arm, prospective registry with 60 pediatric patients age 18 to 21. Visits will be scheduled at pre-implant, post-implant, 6 months, and yearly thereafter through 5 years.

Rationale

This evidence review was created in April 2005 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 6, 2024.

This review was informed by TEC Assessments on surgical management and radiofrequency volumetric tissue reduction for obstructive sleep apnea (OSA).^4,

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 1 or more intended clinical use 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.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Obstructive Sleep Apnea

Obstructive sleep apnea (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.^5, 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 8.01.67. 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.

Clinical Context and Therapy Purpose

The purpose of minimally invasive surgery in patients who have OSA is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The population of interest is patients with OSA who have failed or are intolerant of positive airway pressure (PAP). Indications for the various procedures are described in Table 3 and in the Regulatory Status section.

Interventions

The interventions addressed in this review are laser-assisted uvulopalatoplasty (LAUP), radiofrequency (RF) volumetric reduction of palatal tissues and base of tongue, palatal stiffening procedures, tongue base suspension, and hypoglossal nerve stimulation (HNS) (see Table 3).

Table 3. Minimally Invasive Surgical Interventions for Obstructive Sleep Apnea

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 individuals with mild OSA who are intolerant of CPAP, the comparator would be oral appliances (see Evidence Review 8.01.67 on diagnosis and medical management of OSA) or an established upper airway surgical procedure.

For individuals with moderate-to-severe OSA who have failed CPAP or are intolerant of CPAP, the comparator would be conventional surgical procedures such as maxillofacial surgeries that may include UPPP, hyoid suspensions, maxillary and mandibular osteotomies, and modification of the tongue. UPPP may be modified or combined with a tongue base procedure such as UPPP, depending on the location of the obstruction. It is uncertain whether UPPP variants without tongue volume reduction are the most appropriate comparator for HNS, since the procedures may address different sources of obstruction.

Outcomes

Established surgical procedures are associated with adverse 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.

The outcomes measure used to evaluate treatment success 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 Obstructive Sleep Apnea

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Score; FOSQ: Functional Outcomes of Sleep Questionnaire; MCID: minimum clinically import difference; OSA; obstructive sleep apnea; VAS: visual analog score.

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.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Population Reference No. 1

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.^8, 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. 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

AHI: Apnea/Hypopnea Index; LAUP: laser-assisted uvulopalatoplasty; OSA: obstructive sleep apnea.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

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Scale (maximum of 24); LAUP: laser-assisted uvulopalatoplasty; NS: not significant; NR: not reported; SAQLI: Sleep Apnea Quality of Life Index (maximum of 7); VAS: visual analog scale.

Study limitations are described in Tables 7 and 8. The major flaw is the uncertain clinical significance of the outcome measure.

Table 7. Study Relevance Limitations

The study limitations 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.a 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.b 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 Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b 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.

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 that the technology results in an improvement in the net health outcome.

Population Reference No. 2 

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.^9, All studies were nonrandomized.

Review of Evidence

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, visual analog scale (VAS) for snoring, ESS, or FOSQ between RF and sham (see Tables 9 through 11).^10, The second trial (Woodson et al, 2003), provided a mean of 4.8 sessions of RF to the tongue and palate. This trial found a statistically significant improvement from baseline to post-treatment for ESS and FOSQ.^11, However, the improvement in the FOSQ score (1.2; standard deviation [SD], 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 Tables 10 and 12).

Table 9. Summary of Key Randomized Controlled Trial Characteristics

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

Table 10. Summary of Key Randomized Controlled Trial Results

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; RF: radiofrequency; 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;bp=.005 for baseline to post-treatment.

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

Table 11. Study Relevance Limitations

The study limitations 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.a 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.b 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 Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b 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.

Observational Studies

Herman et al (2023) published a prospective, open-label, single-arm, nonrandomized trial that investigated multilevel RFA as an alternative therapy for patients with mild-to-moderate OSA (AHI 10 to 30) with intolerance or inadequate adherence to CPAP.^12, Patients were treated with 3 sessions of office-based RFA to the soft palate and tongue base. Of the 56 patients recruited for the study, 43 completed the protocol. Overall, 22/43 (51%) were considered complete responders with a ≥50% reduction in baseline AHI and an overall AHI <20 at study completion. A statistically significant reduction in mean and median AHI was observed at 6 months follow‐up (p=.001 for both); the mean AHI decreased from 19.7 to 9.86 and the median AHI decreased from 17.8 to 7.5. Likewise, ODI scores were significantly reduced at 6 months follow‐up; the mean ODI score decreased from 12.79 to 8.36 (p=.006) and the median ODI score decreased from 11.65 to 6.23 (p=.008).

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, and a prospective, single-arm cohort study. Single-stage RF to palatal tissues did not improve outcomes compared with sham. Multiple sessions of RF to the palate and base of the tongue did not significantly (statistically or clinically) improve AHI, while the improvement in functional outcomes did not achieve a level of clinical significance. The prospective cohort study included 56 patients with mild-to-moderate OSA who received 3 sessions of office-based multilevel RFA. Results demonstrated improvement in AHI and Oxygen Desaturation Index (ODI) at the 6-month follow up.

Population Reference No. 3 

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 operations are intended for snoring and are not discussed here. Palatal implants are cylindrically shaped devices that are implanted in the soft palate.

Review of Evidence

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.^13, In the study by Friedman et al (2008), there was greater success in AHI (45% vs 0%, p<.001), improvement in snoring (-4.7 vs -0.7 on a 10-point VAS, p<.001), and improvement in ESS (-2.4 vs -0.5, p<.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. 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

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

Table 14. Summary of Key Randomized Controlled Trial Results

AHI: Apnea/Hypopnea Index; CI: confidence interval; ESS: Epworth Sleepiness Score; FOSQ: Functional Outcomes of Sleep Questionnaire; MD: mean difference; NS: not significant; 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).^14, Compared with nonresponders, responders had lower body mass index (BMI), 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 case series and the RCTs described above.

Table 15. Summary of Key Case Series Characteristics

OSA: obstructive sleep apnea.

Table 16. Summary of Key Case Series Results

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

Table 17. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a 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.b 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 Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b 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 and several case series have assessed palatal implants for the treatment of snoring and OSA. The sham-controlled 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.

Population Reference No. 4

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 suspension aims to make it less likely for the base of the tongue to prolapse during sleep.

Review of Evidence

One preliminary RCT with 17 patients was identified that compared UPPP plus tongue suspension with UPPP plus tongue advancement (see Table 19).^15, 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

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

Table 20. Summary of Key Randomized Controlled Trial Results

AHI: Apnea/Hypopnea Index; ESS: Epworth Sleepiness Score; SD: standard deviation; UPPP:uvulopalatopharyngoplasty.a Baseline to post-treatment p=.02. b Baseline to post-treatment p=.007. c Baseline to post-treatment p=.04. d Baseline to post-treatment p=.004. 

Table 21. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a 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.b 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 Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b 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. Additional RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to UPPP improves the net health outcome.

Population Reference No. 5

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.

Review of Evidence

Systematic Reviews

A summary of systematic reviews is included in Tables 23 and 24.

Costantino et al (2020) conducted a systematic review and meta-analysis of 6- to 60-month outcomes following HNS^17, They identified 12 studies with a total of 350 patients with OSA who were treated with the Inspire, ImThera, or Apnex HNS systems. Only the Inspire device has obtained FDA approval as of May 2022, and contributed the largest number of patients to the meta-analysis. In addition to the trials described below by Steffen et al (2015, 2018)^18,19, and Strollo et al (Stimulation Therapy for Apnea Reduction [STAR] Trial, 2014, 2018)^20,21,, several other trials with the Inspire system were included in the meta-analysis. At 6 mo follow-up, the overall change in AHI was -17.74 with an improvement in ESS of -5.36. At 12 mo follow-up, the change in AHI was -17.50 with an improvement in ESS of -5.27. Sixty-month data were provided only by the STAR trial as reported by Woodson et al (2018) and are described below.^22,

Table 23. Meta-analysis Characteristics

OSA: obstructive sleep apnea

Table 24. Meta-analysis Results

AHI: Apnea/Hypopnea Index; CI: confidence interval; ESS: Epworth Sleepiness Score.aSurgical success according to Sher criteria is defined as a 50% recution in AHI and overall AHI <20.

Randomized Controlled Trials

Schwartz et al (2023) published results from the ImThera Medical Targeted Hypoglossal Neurostimulation Study #3 (THN3), which investigated the efficacy and safety of targeted HNS of the proximal hypoglosal nerve in patients with moderate-to-severe OSA (AHI 20-60 events per hour) and a BMI of 35 kg/m² or less.^24, This was a multicenter, randomized trial where all patients (N=138) were implanted with the HNS system (aura6000; ImThera Medical), and randomly assigned 2:1 to HNS device activation at 1 or 4 months after implant for the treatment and control groups, respectively. Efficacy was measured at month 4, as well as after 11 months of therapy (study months 12 and 15 for treatment and control groups, respectively). The study included mostly males (86.2%) and White individuals (91.3%). The results demonstrated that at month 4, the treatment group had significantly better outcomes compared to the control group for AHI and ODI scores. However, after 11 months of active therapy, the difference between the treatment and control groups was not statistically significant for AHI (RR, -7.5; 95% CI, -16 to 1.4) but remained significant for ODI (RR, 10.4; 95% CI, 1.6 to 18.8). The authors noted that the results should only be applied to patients with moderate-to-severe OSA and a BMI of 35 kg/m² or less.

Heiser et al (2021) conducted The Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea (EFFECT) trial, a multicenter, randomized, double-blind, crossover design study in adult patients with moderate-to-severe OSA (defined as AHI >15) who were intolerant to CPAP.^25, All individuals included in the study were White. All patients received implantation of HNS device (Inspire Medical Solutions) at least 6 months prior to enrollment. Baseline AHI before implantation was 32.2 events/h; after implantation, baseline AHI was approximately 8.3 events/h. All participants received therapeutic stimulation during the baseline visit. Patients were then randomized to 1 of 2 treatment groups: HNS-Sham (n=45) or Sham-HNS (n=44). After randomization, the HNS-Sham group received therapeutic stimulation and the Sham-HNS received sham stimulation for 1 week. During the second week, the HNS-Sham group received sham stimulation while the Sham-HNS group received therapeutic stimulation. Changes in AHI over time showed a statistically significant decrease in AHI with stimulation compared to sham stimulation during the baseline, week 1, and week 2 visits. This meant that during week 1 when the HNS-Sham group received stimulation, they had significantly lower AHI; during week 2, when the Sham-HNS group received stimulation, they had significantly lower AHI. Similarly, participants reported a lower ESS with stimulation compared to sham stimulation during all visits. The change of AHI and ESS from baseline to the 1-week and 2-week visits was analyzed between the groups and investigators found no evidence of a carryover effect for AHI or ESS.

Dedhia et al (2024) conducted a double-blind, randomized, crossover study comparing cardiovascular outcomes in patients (N=60) with severe OSA who had an HNS device implanted.^26, Patients were randomized to a 4-week period of active HNS and a 4-week period of sham HNS. The primary endpoint was mean 24-hour systolic blood pressure. In patients with a BMI of 30 kg/2 or more, the decrease in SBP (+0.5 mmHg vs. -0.64 mmHg) and DBP (-0.17 mmHg vs. -0.25 mmHg) measurements were numerically smaller than those who had a lower BMI; however, the clinical importance of this is unclear).

Table 25. Summary of Key RCT Characteristics

AHI: Apnea/Hypopnea Index; CPAP: continuous positive airway pressure; HNS: hypoglossal nerve stimulation; OSA: obstructive sleep apnea; RCT: randomized controlled trial.

Table 26. Summary of Key RCT Results

AHI: Apnea/Hypopnea Index; CI: confidence interval; ESS: Epworth Sleepiness Scale; FOSQ: Functional Outcomes of Sleep Questionnaire; HNS: hypoglossal nerve stimulation; HR: hazard ratio; NNT: number needed to treat; ODI: oxygen desaturation index; OR: odds ratio; RCT: randomized controlled trial; RR: relative risk.

Notable study limitations are described in Tables 27 and 28.

Table 27. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 28. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.d Data Completeness 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); 7. Other.e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Comparative Studies

Study characteristics and results are described in Tables 29 and 30. Limitations in relevance and design and conduct, including comparative studies and 2 single-arm studies, are described in Tables 31 and 32.

Besides the RCT described above, comparative evidence consists of 3 studies that compared HNS with historical controls treated with UPPP or a variant of UPPP (expansion sphincter pharyngoplasty) and a study that compared HNS with transoral robotic surgery. AHI success by the Sher criteria ranged from 87% to 100% in the HNS groups compared with 40% to 64% in the UPPP groups. Post-treatment ESS was below 10 in both groups. It is not clear from some 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.

Several comparative studies have addressed these concerns by only including patients who meet the criteria for HNS in the control group. Yu et al (2019) compared outcomes for patients who met the criteria for both HNS (non-concentric collapse on drug-induced sleep endoscopy) and transoral robotic surgery (retroglossal obstruction).^25, When patients with similar anatomic criteria were compared, HNS led to significantly better improvements in AHI, cure rate (defined as AHI <5), and the percentage of time that oxygen saturation fell below 90%. Huntley et al (2021) selected patients in the control group who met the criteria for HNS (non-concentric collapse on drug-induced sleep endoscopy and BMI criteria) but had been treated at their institutions by single or multi-level palatal and lingual surgery.^26, There was no explanation of why the different treatments were given during the overlap period of 2010 to 2019, but the HNS patients were older and heavier. HNS resulted in a modestly greater decrease in AHI (HNS: -21.4 vs -15.9. p<.001), but not in ESS (HNS: -4.7 vs -5.8, p=.06). More patients in the HNS group achieved success by the Sher criteria (70% vs 48 to 49%) suggesting that there might be a clinical benefit for some patients.

Another report from Adherence and Outcome of Upper Airway Stimulation for OSA International Registry (ADHERE) registry investigators (Mehra et al, 2020) compared outcomes from HNS patients with patients who met the criteria but had been denied insurance coverage.^27, In a post-hoc multivariate analysis, previous use of PAP and prior surgical procedures were predictors of insurance approval. In the group of patients who received HNS, the average use downloaded from the device was 5.6 h/night and 92% of patients had usage greater than 20 h/week. A majority of the comparator group (86%) were not using any therapy at follow-up. The remaining 14% were using PAP, an oral appliance, or underwent OSA surgery. The AHI decreased to 15 events/h (moderate OSA) on the night of the sleep test in patients with HNS, with only a modest improvement in patients who did not receive HNS. The hours of use on the night of the post-operative sleep study were not reported, and the HNS patients may have been more likely to use their device on the test night. In addition, the use of a home sleep test for follow-up may underestimate the AHI. The ESS improved in the HNS group but worsened in the controls. This suggests the possibility of bias in this subjective measure in patients who were denied coverage.

Additional non-comparative reports from the ADHERE registry are described below.

Table 29. Summary of Observational Comparative Study Characteristics

AHI: Apnea/Hypopnea Index; BMI: body mass index; CPAP: continuous positive airway pressure; ESP: expansion sphincter pharyngoplasty; HNS: hypoglossal nerve stimulation; NR: not reported; OSA: obstructive sleep apnea; PSG: polysomnography; TORS: transoral robotic surgery; UPPP: uvulopalatopharyngoplasty.a A favorable pattern of palatal collapse is not concentric retropalatal obstruction on drug-induced sleep endoscopy.

Table 30. Summary of Key Observational Comparative Study Results

AHI: Apnea/Hypopnea Index; ESP: expansion sphincter pharyngoplasty; ESS: Epworth Sleepiness Score; HNS: hypoglossal nerve stimulation; NS: not significant; Sher criteria: 50% decrease in AHI and final AHI <20; SD; standard deviation; SaO2: oxygen saturation; TORS: transoral robotic surgery; UPPP: uvulopalatopharyngoplasty.a Baseline vs post-treatment p<.05.b Baseline vs post-treatment p<.001.

Table 31. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.ESP: expansion sphincter pharyngoplasty; HNS: hypoglossal nerve stimulation; PSG: polysomnography; STAR: Stimulation Therapy for Apnea Reduction; UPPP: uvulopalatopharyngoplasty.a 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.b 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 32. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.STAR: Stimulation Therapy for Apnea Reduction.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b 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

Characteristics and results of single-arm studies are described in Tables 33 to 35. Limitations are mentioned in Tables 31 and 32, above.

Results of prospective single-arm studies show AHI success rates in 66% to 68% of patients who had moderate-to-severe sleep apnea and a favorable pattern of palatal collapse. Mean AHI was 31 to 32 at baseline, decreasing to 14 to 15 at 12 months. ESS scores decreased from 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 35). In the post-market study, a normal ESS score (<10) was obtained in 73% of patients. A FOSQ score of at least 19 was observed in 59% of patients compared to 13% at baseline. At the 12-month follow-up, 8% of bed partners regularly left the room due to snoring, compared to 75% of bed partners at baseline. The average use was 5.6 + 2.1 hours per night. Use was correlated with the subjective outcomes, but not with AHI response. Two- and 3-year follow-up of this study were reported by Steffen et al (2020)^19,, but the percentage of patients at follow-up was only 68% at 2 years and 63% at 3 years, limiting conclusions about the longer-term efficacy of the procedure. A comparison of the populations who had 12-month versus 2- or 3-year results showed several differences between the patients who followed up and those who dropped out, including higher baseline AHI, higher baseline Oxygen Desaturation Index (ODI), and trends towards lower usage per night and a lower responder rate at 12 months.

Table 33. Summary of Prospective Single-Arm Study Characteristics

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

Table 34. Summary of Prospective Single-Arm Study Results

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.a Ninety-eight participants agreed to undergo PSG at 36 months, of the 17 participants who did not undergo PSG at 36 months, 54% were non-responders and their PSG results at 12 or 18 months were carried forward. b The change from baseline was significant at p<.001.c Seventy-one participants agreed to a PSG.d p<.001.e p<.05.f Four patients lost to follow-up were analyzed as treatment failures.

Table 35. Device-Related Adverse Events From Prospective Single-Arm Studies

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

Down Syndrome

Liu et al (2022) published a systematic review investigating HNS in adolescents with Down Syndrome and OSA.^37, A total of 9 studies were included with a follow up period ranging from 2 to 58 months; 6 studies had sample sizes fewer than 10 patients. The largest of the included studies was a prospective cohort study published by Yu et al (2022), which is summarized below. In an analysis that included 104 patients, AHI scores were significantly reduced in patients after HNS (mean AHI reduction, 17.43 events/h; 95% CI, 13.98 to 20.88 events/h; p<.001). Similarly, in an analysis that included 88 patients, OSA-18 survey scores were significantly reduced after HNS (mean OSA-18 reduction, 1.67; 95% CI, 1.27 to 2.08; p<.001).

Yu et al (2022) reported on the safety and effectiveness of HNS in 42 adolescents with Down Syndrome and severe OSA (AHI of 10 events/h or greater).^38, This was a single-group, multicenter, cohort study with a 1-year follow-up that included non-obese (BMI <95%) children and adolescents aged 10 to 21 years who were refractory to adenotonsillectomy and unable to tolerate CPAP. Patients who were included had an AHI between 10 and 50 on baseline PSG; the mean baseline AHI was 23.5 (SD, 9.7). All patients included tolerated HNS without any intraoperative complications. The most common complication was tongue or oral discomfort or pain, which occurred in 5 (11.9%) patients and was temporary, lasting weeks or rarely, months. Four patients (9.5%) had device extrusion resulting in readmissions to replace the extruded device. At 12 months, there was a mean decrease in AHI of 12.9 (SD, 13.2) events per hour (95% CI, -17.0 to -8.7 events/h). At the 12-month PSG, 30 of 41 patients (73.2%) had an AHI of less than 10 events/h, 14/41 patients (34.1%) had an AHI of less than 5 events/h, and 3/41 patients (7.3%) had an AHI of less than 2 events/h. There was also a significant improvement in quality of life outcomes. The mean improvement in the OSA-18 total score was 34.8 (SD, 20.3; 95% CI, -42.1 to -27.5) and the ESS improved by 5.1 (SD, 6.9; 95% CI, -7.4 to -2.8).

Registry

Boon et al (2018) reported results from 301 patients in the multicenter Adherence and Outcome of Upper Airway Stimulation for OSA International Registry (ADHERE).^41, The ADHERE registry included both retrospective and prospectively collected data from the U.S. and Germany between October 2016 and September 2017. Data were collected from PSG prior to implantation and between 2 and 6 months after implantation, or from home sleep tests which were often performed at 6 and 12 months after implantation as part of routine care. Mean AHI decreased from 35.6 (SD, 15.3) to 10.2 (SD, 12.9) post-titration with 48% of patients achieving an AHI of 5 or less. ESS decreased from 11.9 (5.5) to 7.5 (4.7) (p<.001).

Kent et al (2019) pooled data from the ADHERE registry plus data from 3 other studies to evaluate factors predicting success.^42, Over 80% of the 584 patients were men, and most were overweight. Seventy-seven percent of patients achieved treatment success, defined as a decrease in AHI by at least 50% and below 20 events/per hour. AHI decreased to below 5 in 41.8% of patients. Greater efficacy was observed in patients with a higher preoperative AHI, older patient age, and lower BMI. A report of data from the ADHERE registry by Thaler et al (2020) included 640 patients with 6-month follow-up and 382 with 12-month follow-up.^43, AHI was reduced from 35.8 at baseline to 14.2 at 12 months (p<.001), although the number of hours of use during the sleep test was not reported and home sleep studies may underestimate AHI. ESS was reduced from 11.4 at baseline to 7.2 at 12 months (p<.001), and patient satisfaction was high. In a multivariate model, only female sex (OR, 3.634; p=.004) and lower BMI (OR, 0.913; p=.011) were significant predictors of response according to the Sher criteria. In sensitivity analysis, higher baseline AHI was also found to be a negative predictor of success.

Suurna et al (2021) evaluated the impact of BMI on HNS using the ADHERE registry (N=1849).^44, The mean BMI of all patients in the registry was 29.3 kg/m². All patients had a BMI of 35 kg/m² or lower and were categorized as those with BMI of 32 kg/m² or less and those with a BMI greater than 32kg/m² and less than or equal to 35 kg/m². At 12 months, both groups had reduced AHI events/hour compared with baseline, although the mean change was greater in the lower BMI group (-21.4) compared with the higher BMI group (-20.3; mean difference 1.05 with the upper 97.5% CI at 4.5 which fell within the noninferiority margin). The difference in ESS scores between groups was also noninferior.

In a retrospective analysis by Huntley et al (2018) of procedures at 2 academic institutions, patients with a BMI of greater than 32 did not have lower success rates than patients with a BMI less than 32.^45, However, only patients who had palpable cervical landmarks and carried most of their weight in the waist and hips were offered HNS. Therefore, findings from this study are limited to this select group of patients with BMI greater than 32.

Patel et al (2024) conducted a retrospective cohort study at a single academic institution evaluating the effects of BMI on response to HNS.^46, A total of 76 patients with an average age of 61 years and a median BMI of 28.9 kg/m² were identified. Patients with a BMI of 32 to 35 kg/m² had 75% lower odds of a response to HNS (OR, 0.25; 95% CI, 0.07 to 0.90). Further analysis revealed an approximate 17% decrease in odds of being a responder for each 1 unit BMI increase.

Section Summary: Hypoglossal Nerve Stimulation

The evidence on HNS for the treatment of OSA includes systematic reviews, 2 RCTs, nonrandomized prospective studies, nonrandomized studies with historical controls, and prospective single-arm studies. An RCT of 89 adults with moderate-to-severe OSA who did not tolerate CPAP found significant short-term improvement in AHI, ESS, and quality of life measures with HNS compared to sham stimulation. The study was limited by short duration of follow-up and lack of diverse individuals included in the trial. Another RCT including 138 patients with moderate-to-severe OSA who did not tolerate CPAP compared outcomes for patients who received HNS therapy at 1 or 4 months after implant for the treatment and control groups, respectively. Results demonstrated significant short-term improvement in AHI and ODI when comparing HNS to no HNS at month 4. However, after 11 months of active therapy, the difference between the treatment and control groups was not statistically significant for AHI, but remained significant for ODI in favor of the treatment group. This trial was also limited by a lack of diverse individuals, as well as a lack of a true control group for long-term outcomes. In nonrandomized studies, about two-thirds of patients with moderate-to-severe OSA who had failed conservative therapy (CPAP) and had a favorable pattern of palatal collapse met the study definition of success. Results observed at the 12-month follow-up were maintained at 5 years in the pivotal study. A prospective study that compared outcomes in patients who had received HNS to patients who were denied insurance coverage reported significant differences in both objective and subjective measures of OSA. However, there is a high potential for performance bias in this non-blinded study. For children and adolescents with OSA and Down Syndrome who are unable to tolerate CPAP, the evidence includes a systematic review and a prospective study of 42 individuals. The systematic review investigated HNS in adolescents with Down Syndrome and OSA, and demonstrated significant improvement in AHI and OSA-18 after HNS. The study of 42 individuals with Down Syndrome and OSA found a success rate of 73.2% with 4 device extrusions corrected with replacement surgery.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

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

Clinical input was sought to help determine whether the use of hypoglossal nerve stimulation (HNS) for individuals with obstructive sleep apnea (OSA) would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 2 respondents, including 1 specialty society-level response and physicians with academic medical center affiliation.

For individuals who have OSA who receive HNS, clinical input supports that this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in subgroups of appropriately selected patients. One subgroup includes 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 Apnea/Hypopnea Index (AHI) with HNS, as shown in the STAR trial, is similar to the improvement in AHI following MMA. Another subgroup includes appropriately selected adolescents with OSA and Down's syndrome who have difficulty in using continuous positive airway pressure (CPAP). The following patient selection criteria 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/m² in adults; AND

• Favorable pattern of palatal collapse

Further details from clinical input are included in the Appendix.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Sleep Medicine

The American Academy of Sleep Medicine (AASM, 2021) published practice guidelines on when to refer patients for surgical modifications of the upper airway for OSA.^47, These guidelines replaced the 2010 practice parameters for surgical modifications.^48, The AASM guidelines note that positive airway pressure (PAP) is the most efficacious treatment for OSA, but effectiveness can be compromised when patients are unable to adhere to therapy or obtain an adequate benefit, which is when surgical management may be indicated. The AASM guideline recommendations are based on a systematic review and meta-analysis of 274 studies of surgical interventions, including procedures such as uvulopalatopharyngoplasty (UPPP), modified UPPP, MMA, tongue base suspension, and hypoglossal nerve stimulation.^49, The systematic review deemed most included data of low quality, consisting of mostly observational data. The AASM strongly recommends that clinicians discuss referral to a sleep surgeon with adults with OSA and body mass index (BMI) <40 kg/m2 who are intolerant or unaccepting of PAP. Clinically meaningful and beneficial differences in nearly all critical outcomes, including a decrease in excessive sleepiness, improved quality of life (QOL), improved Apnea/Hypopnea Index (AHI) or respiratory disturbance index (RDI), and sleep quality, were demonstrated with surgical management in patients who are intolerant or unaccepting of PAP. The AASM makes a conditional recommendation that clinicians discuss referral to a sleep surgeon with adults with OSA, BMI <40 kg/m2, and persistent inadequate PAP adherence due to pressure-related side effects, as available data (very low-quality), suggests that upper airway surgery has a moderate effect in reducing minimum therapeutic PAP level and increasing PAP adherence. In adults with OSA and obesity (class II/III, BMI >35) who are intolerant or unaccepting of PAP, the AASM strongly recommends discussion of referral to a bariatric surgeon, along with other weight-loss strategies.

American Academy of Pediatrics

The American Academy of Pediatrics (2012) published a clinical practice guideline on the diagnosis and management of childhood OSA.^50, 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 OSA 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 (defined as BMI >95th percentile).

American Academy of Otolaryngology - Head and Neck Surgery

The American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS; 2021) has a position statement on surgical management of OSA.^51, 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:

• tracheostomy,

• nasal and pharyngeal airway surgery,

• tonsillectomy and adenoidectomy,

• palatal advancement,

• UPPP,

• genioglossal advancement,

• hyoid myotomy,

• midline glossectomy,

• tongue suspension,

• maxillary and mandibular advancement.

In a 2021 position statement, AAO-HNS supported hypoglossal nerve stimulation as an effective second-line treatment of moderate-to-severe OSA.^52,

American Society for Metabolic and Bariatric Surgery

The American Society for Metabolic and Bariatric Surgery (2012) published guidelines on the perioperative management of OSA.^53, 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, besides CPAP, as opposed to surgical procedures directed at the mandible or tissues of the palate. The updated 2017 guidelines reaffirmed these recommendations.^54,

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) 2017 guidance concluded that evidence on the safety and efficacy of hypoglossal nerve stimulation is limited in quantity and quality, and the procedure should only be used in the context of a clinical trial.^55,

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

The Centers for Medicare & Medicaid Services (CMS; 2001) published a decision memorandum that addressed how to define moderate-to-severe OSA as a guide for a coverage policy on CPAP.^56, Because surgical approaches are considered when CPAP fails, CMS policy was adapted to this evidence review on the surgical management of OSA. The CMS review of the literature suggested there is a risk of hypertension with an AHI or RDI of at least 15 events per hour, and thus treatment is warranted for patients without any additional signs and symptoms. For patients with an AHI or RDI between 5 and 14 and associated symptoms, CMS concluded that the data from randomized controlled trials have demonstrated improved daytime somnolence and functioning in those treated with CPAP.

There is no national coverage determination for hypoglossal nerve stimulation. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 36.

Table 36. Summary of Key Trials

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

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CODES

Applicable Modifiers

N/A

Policy History