Medical Policy

This document addresses surgical treatments for obstructive sleep apnea (OSA), such as uvulopalatopharyngoplasty (UPPP), hyoid myotomy and jaw realignment surgery, laser surgery, radiofrequency ablation, palatal implants, and other procedures. This document does not address tonsillectomy, adenoidectomy or nasal surgery.

Note: For information related to other technologies utilized in the diagnosis and management of sleep-related disorders, please see:

• DME.00039 Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea
• MED.00002 Selected Sleep Testing Services
• CG-MED-79 Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems
• CG-SURG-30 Tonsillectomy for Children with or without Adenoidectomy
• CG-SURG-36 Adenoidectomy

Note: Please see the following document for the use of nasal surgery to treat snoring and OSA

• CG-SURG-87 Nasal Surgery for the Treatment of Obstructive Sleep Apnea and Snoring

Medically Necessary:

Uvulopalatopharyngoplasty (UPPP):

Uvulopalatopharyngoplasty (UPPP) is considered medically necessary when ALL of the following criteria (A-D below) are met:

1. Documented OSA with apnea hypopnea index (AHI) or respiratory disturbance index (RDI) meeting any of the following:
   1. UPPP as sole procedure with AHI (or RDI) greater than 15 events per hour and less than 40 events per hour,  
      or
   2. UPPP as sole procedure with AHI (or RDI) between 10-15 events per hour and one or more of the conditions listed below:
      1. Hypertension; or
      2. Cardiac arrhythmias predominately during sleep; or
      3. Pulmonary hypertension; or
      4. Documented ischemic heart disease; or
      5. Impaired cognition or mood disorders; or
      6. History of stroke; or
      7. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (for example, during driving, conversation or eating) or sleepiness that interferes with daily activities.
         or
   3. UPPP as part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction, (for example, genioglossal advancement, hyoid myotomy and suspension) with AHI (or RDI) greater than 15 events per hour,
      or
   4. UPPP as part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction, (for example, genioglossal advancement, hyoid myotomy and suspension) with AHI (or RDI) between 10-15 events per hour and one or more of the conditions listed below:
      1. Hypertension; or
      2. Cardiac arrhythmias predominately during sleep; or
      3. Pulmonary hypertension; or
      4. Documented ischemic heart disease; or
      5. Impaired cognition or mood disorders; or
      6. History of stroke; or
      7. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (for example, during driving, conversation or eating) or sleepiness that interferes with daily activities.
         and
2. Have failed treatment with CPAP as demonstrated by any of the following:
   1. Claustrophobia from CPAP; or
   2. Inability to breathe through the nose; or
   3. Pain or discomfort from CPAP; or
   4. User intolerance to CPAP; or
   5. Individuals at high pressures of CPAP (greater than 10 cm H₂O) complaining of pressure discomfort.
      and
3. Fiberoptic endoscopy suggests retro-palatal narrowing is the primary source of airway obstruction if UPPP is the sole procedure or a contributing source of airway obstruction if part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction;
   and
4. The individual is 18 years of age or older, or there is documentation that skeletal growth is complete based on long bone x-ray or serial cephalometrics showing no change in facial bone relationships for at least the last three consecutive months.

Soft Tissue Reconstruction:

Hyoid myotomy and suspension, with or without mandibular osteotomy with genioglossus (tongue) advancement, for the treatment of OSA is considered medically necessary when ALL of the following criteria (A-D below) are met:

1. The treatment of OSA in the individual is medically necessary based on either 1) or 2) below:
   1. AHI or RDI greater than or equal to 15 events per hour;
      or
   2. AHI (or RDI) greater than or equal to 5 events per hour, and less than 15 events per hour with documentation demonstrating any of the following symptoms:
      1. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness scale or inappropriate daytime napping, (for example, during driving, conversation or eating) or sleepiness that interferes with daily activities; or
      2. Impaired cognition or mood disorders; or
      3. Hypertension; or
      4. Ischemic heart disease or history of stroke; or
      5. Cardiac arrhythmias, or
      6. Pulmonary hypertension.
         and
2. The individual has failed treatment with CPAP as demonstrated by any of the following:
   1. Claustrophobia from CPAP; or
   2. Inability to breathe through the nose; or
   3. Pain or discomfort from CPAP; or
   4. User intolerance to CPAP; or
   5. Individuals at high pressures of CPAP (greater than 10 cm H₂O) complaining of pressure discomfort.
      and
3. There are significant soft tissue and/or tongue base abnormalities with airway collapse. (Objective evidence of hypopharyngeal obstruction may be documented by either fiberoptic endoscopy or cephalometric radiographs.);
   and
4. The individual is 18 years of age or older, or there is documentation that skeletal growth is complete based on long bone x-ray or serial cephalometrics showing no change in facial bone relationships for at least the last three consecutive months.

Jaw Realignment Surgery:

Jaw realignment surgery (that is, maxillomandibular advancement) is considered medically necessary when ALL of the following criteria (A-D below) are met:

1. The treatment of OSA in the individual is medically necessary based on either 1) or 2) below:
   1. AHI or RDI greater than or equal to 15 events per hour;
      or
   2. AHI (or RDI) greater than or equal to 5 events per hour, and less than 15 events per hour with documentation demonstrating any of the following symptoms:
      1. Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness scale or inappropriate daytime napping, (for example, during driving, conversation or eating) or sleepiness that interferes with daily activities; or
      2. Impaired cognition or mood disorders; or
      3. Hypertension; or
      4. Ischemic heart disease or history of stroke; or
      5. Cardiac arrhythmias, or
      6. Pulmonary hypertension.
         and
2. The individual has failed treatment with CPAP as demonstrated by any of the following:
   1. Claustrophobia from CPAP; or
   2. Inability to breathe through the nose; or
   3. Pain or discomfort from CPAP; or
   4. User intolerance to CPAP; or
   5. Individuals at high pressures of CPAP (greater than 10 cm H₂O) complaining of pressure discomfort.
      and
3. The individual has failed surgical intervention with any of the following:
   1. UPPP; or
   2. Genioglossus advancement and/or hyoid myotomy with suspension; or
   3. Both of these surgical procedures.
      and
4. The individual is 18 years of age or older, or there is documentation that skeletal growth is complete based on long bone x-ray or serial cephalometrics showing no change in facial bone relationships for at least the last three consecutive months.

Jaw realignment surgery is also considered medically necessary for individuals with a documented severe jaw/facial bony abnormality that contributes to OSA, including, but not limited to, craniofacial abnormalities, micrognathia, retrognathia or small retro-positioned jaw with associated overbite and small mouth.

Note: Individuals undergoing jaw realignment surgery may also undergo orthodontic therapy. Orthodontic therapy (that is, placement of orthodontic brackets and wires) may not be a covered benefit under all member benefit plans.

Not Medically Necessary:

Uvulopalatopharyngoplasty, soft tissue reconstruction, or jaw realignment surgery are considered not medically necessary when the criteria above are not met.

UPPP as a sole procedure with AHI/RDI under 10 events per hour is considered not medically necessary.

Treatment of snoring without OSA is considered not medically necessary including, but not limited to the use of the following treatment methods:

1. UPPP; 
2. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue, including Somnoplasty^® and Coblation^®;
3. Laser-Assisted Uvulopalatoplasty (LAUP);
4. Cautery Assisted Palatal Stiffening Operation (CAPSO) or Palatal Implants.

Investigational and Not Medically Necessary:

The use of palatal implants is considered investigational and not medically necessary including, but not limited to:

1. Injection snoreplasty;
2. The Pillar^™ system.

UPPP is considered investigational and not medically necessary for UARS (upper airway resistance syndrome).

Other surgical treatments for OSA are considered investigational and not medically necessary including, but not limited to, the following:

1. Cautery-assisted Palatal Stiffening Operation (CAPSO);
2. Laser-Assisted Uvulopalatoplasty (LAUP);
3. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue including Somnoplasty and Coblation; 
4. Transpalatal advancement pharyngoplasty;
5. Bone-anchored tongue base suspension systems by permanent suture techniques (which include the AIRvance^™ System [formerly the Repose^® System] and the ENCORE^™ Tongue Suspension System).
6. Hypoglossal nerve stimulation (Inspire^® Upper Airway Stimulation system).

In 2009, the American Academy of Sleep Medicine (AASM), formerly known as the American Sleep Disorders Association, released the Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. This guideline addressed several surgical treatments of OSA, including the following:

• Individuals with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention than with the use of oral appliances (OAs).
• Evaluation for primary surgical treatment can be considered in persons with mild OSA who have severe obstructing anatomy that is surgically correctible, (for example, tonsillar hypertrophy obstructing the pharyngeal airway).
• Although the specifics of sleep apnea surgeries are beyond the scope of this guideline, surgical procedures may be considered as a secondary treatment for OSA when the outcome of positive airway pressure (PAP) therapy is inadequate, such as when the individual is intolerant of PAP, or PAP therapy is unable to eliminate OSA.
• Surgery may also be considered as an adjunct therapy when obstructive anatomy or functional deficiencies compromise other therapies or to improve tolerance of other OSA treatments.
• Maxillary and mandibular advancement (MMA) can improve polysomnography (PSG) parameters comparable to CPAP in the majority of individuals.
• Most other sleep apnea surgeries are rarely curative for OSA but may improve clinical outcomes, (e.g., mortality, cardiovascular risk, motor vehicle accidents, function, quality of life (QOL), and symptoms).
• Laser-assisted uvulopalatoplasty (LAUP) is not recommended for the treatment of obstructive sleep apnea (Epstein, 2009).

In 2010, the AASM published practice parameters for Surgical Modifications of the Upper Airway for OSA in Adults (Aurora, 2010), which were based on a systematic review and meta-analysis of the evidence currently available (Caples, 2010). Authors of the systematic review/meta-analysis reported that the bulk of the published literature consisted of case series, with a few controlled trials. The studies were characterized by considerable heterogeneity, including varying approaches to pre-operative evaluation and postoperative follow-up. Using the change in AHI as the primary measure of efficacy, substantial and consistent reductions were observed following MMA, and adverse events were not commonly reported. Outcomes following pharyngeal surgeries were less consistent, and adverse events were more commonly reported.

The following is excerpted from the AASM practice parameters:

• MMA, UPPP as a sole procedure or multi-level, or stepwise surgery following failed UPPP as a sole treatment - all received a recommendation of “Option” (uncertain clinical use), due to the lack of rigorous data evaluating surgical modifications of the upper airway;
• RFA also received a recommendation of “Option” for individuals with mild to moderate OSA who cannot tolerate or who are unwilling to adhere to CPAP, or in whom oral appliances have been found ineffective or undesirable;
• Palatal implants received a recommendation of “Option” for those with mild OSA who failed medical therapy;
• LAUP was not recommended as a routine treatment for OSA (“Standard”).
• A recommendation of “Standard” was given for the determination of the presence and severity of OSA before initiating surgical therapy, discussion of success rates, complications, and alternative treatments with the individual, 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, although it was noted that little guidance was available in the medical literature to recommend any particular monitoring strategy nor optimal intervals and duration of follow-up (Aurora, 2010).

UPPP

There is widespread agreement in the published studies of UPPP, as to the definition of "success" of the procedure. This is defined as a reduction in pre-operative AHI/RDI or Apnea index (AI) by at least 50% with a post UPPP AHI/RDI of less than 20; or a post UPPP AI less than 10. Using these definitions, a person whose pre-operative AHI/RDI/AI is less than 10 is already (by definition) "cured" of their OSA and is, therefore, not an appropriate candidate for UPPP. Furthermore, there is no published literature that supports the value of UPPP for this group.

There is also recognition in the literature that UPPP, when performed as the sole procedure, is less likely to be a success when severe OSA is present preoperatively. The AASM defines "severe" as an AHI/RDI greater than 30. There is evidence that UPPP, when performed for individuals with an AHI/RDI greater than 40, is unsuccessful in the vast majority of cases (Friedman, 2005; Janson, 1997; Millman, 2000). This may, in part, be related to the presence of unrecognized coexistent hypopharyngeal obstruction in persons with severe OSA that could not be expected to be adequately relieved by UPPP alone, which addresses only velopharyngeal (retropalatal) obstruction. In a retrospective chart review of 134 subjects having undergone UPPP alone, those whose preoperative AHI was greater than 40 failed to have a successful result (defined as a 50% reduction in AHI with postoperative AHI less than 20) in 73.5% cases. That is to say the success rate was only 26.5% (Friedman, 2005).

Soft Tissue Reconstruction

Hyoid myotomy and suspension, and mandibular osteotomy with genioglossus advancement have been demonstrated in multiple case series studies to provide significant relief of symptoms for individuals suffering from OSA where hypopharyngeal (retrolingual) obstruction during sleep is a significant factor. These soft tissue reconstructive procedures have been shown to successfully alter the anatomy of persons with OSA sufficiently to prevent upper airway collapse. Not all individuals are appropriate for this procedure. Careful evaluation of the upper airway anatomy should take place prior to consideration of this procedure. As with UPPP, hyoid myotomy and suspension, and mandibular osteotomy with genioglossus advancement should not be used as first line treatments, and trials of conservative therapies, such as CPAP, should be attempted first. Hyoid myotomy and suspension, and mandibular osteotomy with genioglossus advancement may be performed, along with UPPP, in selected individuals where both velopharyngeal and hypopharyngeal (retrolingual) obstruction during sleep are thought to occur.

Jaw Realignment Surgery

The use of jaw realignment surgery in persons with OSA who are unresponsive to other therapies has been demonstrated to be an effective treatment. While the results of this procedure have been shown to significantly improve the symptoms of OSA, jaw realignment surgery involves extensive jaw reconstruction. Several articles in the peer-reviewed literature have proposed a stepwise approach to OSA therapy that requires the use of other conservative and surgical interventions, mainly CPAP and UPPP, prior to consideration of jaw realignment surgery.

A meta-analysis by Zaghi and colleagues (2016) evaluated the efficacy of maxillomandibular advancement as a treatment of OSA. A total of 45 studies with individual data from 518 participants were included. The primary outcomes were the changes in AHI and RDI following surgery. Following surgery 98.8% (512/518) reported an improvement in AHI and RDI. Mean postoperative changes in AHI and RDI were -47.8 (25.0) and -44.4 (33.0), respectively. The majority of individuals had a history of prior surgery for OSA (197 of 268 [73.5%]). The authors noted “patients with a high residual RDI and AHI after failure of other surgical procedures for sleep apnea are highly likely to benefit from MMA.”

This conservative approach is appropriate in all but the most extenuating circumstances involving severe maxillofacial malformations related to OSA. The literature on this procedure indicates that success varies with the experience of the surgeon and the facility, and care should be taken in their selection.

Radiofrequency Volumetric Tissue Reduction (RFVTR) or Laser-Assisted Uvulopalatoplasty (LAUP)

At this time, there is inadequate evidence in the published medical literature demonstrating the efficacy of radiofrequency (RF) ablation techniques for the treatment of OSA. One particular technique, RFVTR which focuses on the base of the tongue and soft palate and includes two procedures marketed as Somnoplasty and Coblation, has been described in the medical literature. In a multi-institutional study of 56 subjects with OSA treated with radiofrequency tongue base reduction, the mean pre-operative AHI index of 40.5 decreased only to 32.8 after treatment (Woodson 2001). A randomized controlled trial (RCT), involving 90 subjects with mild to moderate OSA, evaluated RFVTR of both tongue and palate in 30 individuals with comparisons to those receiving CPAP or sham radiofrequency treatment. Results showed that there was no significant reduction in either AHI or nocturnal oxygen desaturation in the RFVTR-treated group compared with the CPAP or sham groups (Woodson 2003). A systematic review and meta-analysis of 20 studies was done to evaluate the efficacy of temperature controlled radiofrequency tissue ablation (TCRFTA) in treating OSA. TCRFTA was categorized based on location: base of tongue, soft palate and multilevel. Analysis showed significant reductions in RDI, Epworth Sleep Scale (ESS), lowest oxygen saturation (LSAT) and snoring for procedures performed at the base of the tongue. TCRFTA at the soft palate showed limited efficacy, although there was a paucity of studies in this area. Multilevel TCFFTA did show a significant reduction in RDI, in the short term. Analysis of AHI was not completed as this outcome was not consistently reported within the studies. The authors reported that the studies were generally of low quality and there was significant heterogeneity which did not allow strong conclusions (Baba, 2015). Studies with longer-term outcomes would be useful in evaluating the benefits of this procedure.

LAUP has primarily been researched as a treatment of snoring without associated clinically significant OSA. As referenced earlier in this document, in 2009, the AASM issued another document, the AASM Clinical Guidelines for the Evaluation, Management, and Long-term Care of OSA in Adults, in which they restated their position not to recommend LAUP (Epstein, 2009). In a recent study by Göktas (2014) evaluating long-term results of LAUP for OSA, the authors followed up with 25 individuals who had LAUP an average of 11 years. The authors noted that a comparison between mean preoperative and postoperative AHI scores did not report statistically significant long-term therapeutic positive outcomes (25.95 versus 23.62). More significantly, a group of individuals showed an increase in AHI following LAUP. Of the 15 individuals considered non-responders, 12 had an increase in AHI by more than 5 events per hour. The authors concluded that LAUP is associated with significant risks of increased postoperative AHI and positive outcomes are not sustained long term.

An updated search of the published literature identified a study by Franklin (2009) who conducted a systematic review to evaluate the efficacy and adverse effects of surgery for snoring and OSA. The review included four RCTs of surgery versus either sham surgery or conservative treatment in adults, and described outcome measures for daytime sleepiness, QOL, AHI, and snoring. Results of this review found that there was no significant effect on daytime sleepiness and QOL following LAUP or RFVTR. The authors concluded that these studies did not provide evidence of therapeutic effect from LAUP or RFVTR on daytime sleepiness, apnea reduction, QOL, or snoring (Franklin, 2009).

Cautery-assisted palatal stiffening operation (CAPSO)

A prospective non-randomized trial using a CAPSO procedure for the treatment of excessive snoring in 206 consecutive subjects reported a “success” rate of 92% initially, falling to 77% at 1 year. Of note is the fact that the subjects with features suggestive of OSA or with evidence of OSA on sleep studies were excluded from the trial (Mair, 2000). A small study involving 25 subjects with OSA reported a 40% success rate in terms of a reduction in AHI of 50% or more reaching to less than 10. The mean AHI improved from 25.1 to 16.6. There was no significant improvement in nocturnal oxygen desaturation, and the follow-up period was only 3 months (Wassmuth, 2000).

ENCORE Tongue Suspension System

Additional treatment methods proposed for OSA utilize the ENCORE Tongue Suspension System (Siesta Medical, Inc., Los Gatos, CA) or the AIRvance (formerly the Repose) Bone-anchored Suspension System (Medtronic, Inc., Minneapolis, MN), and also injection snoreplasty. To date, these treatments have not been evaluated in large controlled trials with long-term outcomes data. At this time, there is insufficient evidence to make any recommendation about the appropriate clinical use of either tongue base suspension systems or injection snoreplasty.

Pillar palatal implant system

To date, the literature has been limited regarding the safety and efficacy of the Pillar palatal implant system for treating OSA. Friedman reported a single institution RCT involving 62 subjects with mild to moderate OSA who were selected based on "Friedman tongue position," soft palate size, and body mass index (BMI) less than 32. Only 29 participants actually received the palatal implant and follow-up analysis. A total of 26 participants underwent a "sham" procedure and analysis as the placebo group. Follow-up was performed at 3 months, and success was defined as an AHI reduction of at least 50% and a post-procedure AHI less than 20. On this basis, 13/29 subjects receiving the implants were a success (44.8%), compared to 0 in the placebo group. However, 4 of the 13 "successes" already had a pre-procedure AHI of less than 20, as did 9 of the 26 in the placebo group. In the implant group, the mean AHI fell from 23.8 to 15.9, this latter number still representing moderate OSA, (as defined by the AASM). In addition, the mean Epworth Sleepiness Scale score fell from 12.7 to 10.2, the latter continuing to represent excessive daytime sleepiness (greater than 10). No individual data were reported, and it is unknown if OSA was completely relieved (AHI less than 5) in any of the trial participants. Mean minimum O₂ saturation rose from 88.3% to 89.7% (significance unclear) with QOL responses following treatment that were measured using an SF 36 rather than a more specific sleep-related QOL measurement tool. Acknowledged limitations of the study by the authors were the short follow-up (which precludes conclusions regarding the durability of the implant procedure) and the potential challenge in generalizing results arising from a limited study population of non-obese, mild to moderate OSA subjects with specific oral physical characteristics where half of the participants evaluated did not qualify for the study (Friedman, 2008).

Walker reported follow-up at approximately 15 months for 22 subjects out of an original 53 undergoing the Pillar palatal implant procedure for mild to moderate OSA at 4 sites in the U.S. Of these 22, 13 had experienced a mean decrease in AHI from 19.5 to 13 at 90 days post implant (an AHI of 13 represents mild OSA by AASM definition). Ten of these 13 (76.9%) maintained a mean AHI of 12.8 (persistent mild OSA) at approximately 15 months post-procedure. There was some concern about the finding that 9/22 subjects, who had not improved 90 days post-procedure, experienced an increase in mean AHI from 19.9 pre-procedure to 28.4 at 90 days post-procedure and 26.2 at extended follow-up. Whether this early and sustained deterioration was related to the failed implant procedure or to the natural history of OSA is unclear. As with the Friedman study, no individual data were reported, and no information was provided as to whether any participants had their OSA totally relieved by the implant procedure. Limitations of this case series study include the small sample size, lack of placebo control group, and the significant number of the original 53 subjects who were lost to follow-up which affected the generalizability of the results (Walker, 2007).

The available studies to date do not provide convincing evidence of the long-term efficacy of palatal implants for persons with OSA. Larger randomized controlled trials with longer follow-up and more complete participant data post-procedure are required to establish the procedure's efficacy for OSA.

Transpalatal advancement pharyngoplasty (TAP)

Another technique that has been proposed as a surgical alternative for the treatment of OSA is TAP. This surgical procedure alters the retro-palatal airway by advancing the palate forward without requiring excision of the soft palate. This procedure pulls the palate forward and superiorly. Conceptually, similarities exist to maxillary advancement without the associated alterations in dentition. The TAP procedure has been purported for use alone or in combination with other soft tissue surgeries for individuals with narrowing in the retro-palatal airway, especially narrowing proximal to the point of palatal excision using traditional UPPP techniques. A transpalatal approach and advancement has also been proposed for individuals with obstructions in the nasopharynx, such as enlarged adenoids, that cannot be accessed through traditional techniques. However, to date, there is very little published outcomes data for persons with OSA. One retrospective review described 30 subjects who underwent a TAP procedure; 20 of these study subjects also had various tongue-base procedures performed at the same time as TAP. Only 10 had TAP alone. The results of postoperative AHI in these 30 subjects were better than a comparable group of 44 subjects undergoing UPPP, 26 of whom had UPPP as the sole procedure. Also, for the subjects in each group who did not have additional tongue base surgery, the AHI improved significantly more in the TAP treated group (n=10) than the UPPP treated group (n=26) (Woodson, 2005.)  Larger studies are needed to establish the safety/efficacy of the TAP procedure, together with prospective comparisons with established palate-based surgical techniques.

Hypoglossal nerve stimulation

A device for hypoglossal nerve stimulation, the Inspire II Upper Airway Stimulation System (UAS) (Inspire Medical Systems, Maple Grove, MN) was approved by the FDA in April 2014. The Inspire UAS is proposed for use in a subset of adults aged 22 and over with moderate to severe OSA with an AHI between 20-65. In addition, evaluation must show that individuals do not have a complete concentric collapse at the soft palate level. Inspire UAS is considered a second level treatment and individuals must have failed or cannot tolerate PAP therapy as noted below:

PAP failure is defined as an inability to eliminate OSA (AHI of greater than 20 despite PAP usage), and PAP intolerance is defined as:
(1) Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or
(2) Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).

The label warned that individuals with a BMI of greater than 32 were not studied in the pivotal trial. Contraindications include:

• Central + mixed apneas > 25% of the total apnea–hypopnea index (AHI)
• Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
• Any condition or procedure that has compromised neurological control of the upper airway
• Patients who are unable or do not have the necessary assistance to operate the sleep remote
• Patients who are pregnant or plan to become pregnant
• Patients who will require magnetic resonance imaging (MRI)
• Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system. Consult the device manufacturer to assess the possibility of interaction.

Strollo and associates (2014) reported on a case series to evaluate the safety and effectiveness of upper airway stimulation using the Inspire Upper Airway Stimulation system (Stimulation Treatment for Apnea Reduction (STAR)). A total of 126 individuals with moderate to severe OSA and low adherence to CPAP were included. Primary outcome measures included AHI and oxygen desaturation index (ODI). Results showed that at 12 months of follow-up, 60% of participants achieved at least a 50% decrease in AHI and 65% met the secondary outcome of reduction in the ODI score of 25% or more. The median AHI decreased 68%, from 29.3 to 9.0 events/hour (mean, 32.0-15.3). The first consecutive 46 participants who were treatment responsive were subsequently randomized to either continued therapy or withdrawal from therapy. After 7 days, AHI of the continued treatment group remained stable from a mean of 7.2 to 8.9 events per hour, while the mean AHI in the withdrawal group increased from 7.6 to 25.8. Two participants experienced serious adverse events associated with the device. The STAR trial continued to follow participants to assess safety and efficacy beyond 12 months. Strollo and associates (2015) reported that at 18 months, the AHI remained decreased from the baseline (29.3 to 9.7 [67.4%]), and the ODI also maintained the decrease from baseline (25.4 to 8.6 [67.5%].)  There were no new safety concerns raised. At 24 months, the Epworth Sleepiness Scale (ESS), intrusive snoring, and daytime function as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ), were used as the outcomes measurements. A total of 111 of 126 participants (88%) completed the 24-month follow-up evaluation. At 24 months, the mean ESS, which decreased significantly from baseline to 12 months, remained unchanged from the 12-month level. The percentage of participants with an ESS score of less than 10 significantly increased from baseline to 12 months and 24 months (32.5%; 74.8% and 77.5% respectively). Both FOSQ and intrusive snoring measures supported that significant improvements shown at 12 months were maintained. Supplemental information published with the 2014 Strollo study provides insight beyond the group means reported in the main paper. These data show that 83 of the 126 subjects (66%) were classified as treatment responders; 43 (33%) were classified as non-responders; and 7 subjects (5.6%) had a worsening of AHI by 15 or more events per hour. An additional 12 subjects had an AHI worsening of less than 15 events per hour. Four subjects experienced AHI worsening of more than 60 events per hour. The authors did not identify any baseline characteristics that might predict who might experience a worsening of AHI with HNS stimulation.

The 36-month outcomes from the STAR trial were published in 2016 (Woodson). The authors noted that the improvements noted at 12 months had persisted at 36 months. A total of 116/126 participants (92%) completed the follow-up evaluation, and 98 (78%) of these individuals underwent a follow-up polysomnogram. The mean AHI, which had decreased from baseline at 12 months, remained stable at 36 months. However, there were fewer 12-month non-responders who agreed to undergo a follow-up polysomnogram, potentially confounding the results. In addition to the stable AHI, this group showed a further small decrease in ODI compared to the 12-month results. The majority of the adverse effects were related to implantation of the device. While the results of these studies are promising, there have been no studies comparing hypoglossal nerve stimulation to other treatments of OSA. In a review of upper airway stimulation therapy, Soose and Gillespie (2016) note “Additional studies are needed to better understand which anatomical and pathophysiologic patient phenotypes are associated with treatment success”.

Woodson and colleagues (2018) reported on the 5-year outcomes of the STAR trial. A total of 97 individuals (78%) completed the 5-year follow-up visit. The mean AHI and the oxygen desaturation index (ODI) decreased at the 1-year follow-up from baseline (mean ± SD: 15.3 ± 16.1 and 14.0 ± 15.6 versus 32.0 ± 11.8 and 28.9 ± 18.2, respectively). The results remained stable at 5 years (mean ± SD: 12.4 ± 16.3 and 9.9 ± 14.5, respectively). In addition to the objective results, the subjective measures on daytime sleepiness and functioning were evaluated using the Epworth Sleepiness Scale (ESS); and Functional Outcomes of Sleep Questionnaire (FOSQ) tools were used. The scores of these tools showed a slight decrease at 12 months and a continuing steady decline through 5 years. After 5 years, 8 individuals (6%) had serious device-related AEs which required surgery to replace or revise the device. The authors noted that there was a lack of diversity in the study group; the group was predominantly male, obese, CPAP intolerant, and of European descent. In addition, the group excluded individuals with comorbidities such as active cardiovascular disease. This calls into question the generalizability of the results.

Certal and colleagues published a systematic review and meta-analysis on hypoglossal nerve stimulation (2015). A total of six studies (five prospective case series and one case report) with 200 participants were included. A pooled, fixed results analysis demonstrated significant improvements in AHI at the 3-, 6- and 12-month timepoints (43.90 ± 17.61/hour (hr) to 20.03 ± 14.15/hr; 43.73 ± 16.55/hr to 18.91 ± 16.47/hr; and 35.45 ± 13.26/hr to 17.55 ± 16.94/ hr respectively). In addition, there were statistically significant reductions in ODI and ESS. There were no reported safety concerns, and none of the studies reported any serious adverse events. The authors note that the quality of the studies included was low, and higher quality evidence in the form of randomized, controlled trials are needed. In addition, there are no trials comparing hypoglossal nerve stimulation to other treatments of OSA.

The Adherence and Outcome of Upper Airway Stimulation for OSA International Registry (ADHERE), an industry sponsored cohort of individuals who received the Inspire device from multiple sites in the United States and Europe, was designed as a follow-up to the STAR trial (Boon, 2018). The registry included those who met the following criteria: moderate to severe OSA, intolerance or inadequate adherence to CPAP, favorable anatomic criteria, device implantation and a willingness to return for routine clinic visits as required. Data was collected retrospectively in those participants who underwent device implantation prior to the creation of the registry and chose to participate in the registry. Registry participation was purely observational; there were no required study specific procedures or treatment plans (Boon, 2018). The ADHERE registry anticipates enrolling a total of 2500 participants. A total of 1017 participants had been enrolled between October 2016 and February 2019 (Thaler, 2020). The registry is comprised of a collection of retrospective and prospective outcome measures, with the first set of data published in 2018 (Boon, 2018). Since that time, several studies have been published using the data from the ADHERE registry.

Boon and associates (2018) evaluated the objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction levels in the first 301 participants enrolled in the ADHERE registry. Withrow and associates (2019) used data from the ADHERE registry to evaluate the impact of age on safety, efficacy, and usage of upper airway stimulation. The study included the data from 600 individuals, which was 20% of the population which had been treated with HNS (600/3000) at the time. The clinical outcomes of participants younger than 65 years old were compared to the clinical outcomes of those aged 65 and older. Heiser and colleagues (2018) reviewed the data of 508 participants to identify the predictors of success. The authors concluded that increasing age and reduced BMI were predictors of treatment response. In 2020, Thaler and colleagues reported on the results of 640 individuals who are enrolled in the ADHERE registry and have completed their 6-month follow-up post implantation. An additional 382 individuals have completed a 12-month follow-up.

While the ADHERE registry represents a large cohort of individuals who underwent implantation, there are concerns about the generalizability and quality of the data. Participation in the registry is voluntary, approximately 20% of the implanted population at all centers consented to participate (Withrow, 2019). The low participation rate raises concerns regarding selection bias. Also, the first 301 participants were primarily middle-aged (mean 59.2 ± 11.2), Caucasian (97%) and male (82%) (Boon, 2018). These demographics remained largely unchanged following enrollment of the first 1017 participants: average age 60 ± 11 years, 74% male and 96% Caucasian (Thaler, 2020). These demographics do not reflect the prevalence rates observed within the community. Petrov and colleagues (2015) noted that the prevalence rate of OSA was comparable between black men and white men and the prevalence rate was substantially larger among black women compared to white women. An estimated 24% of young-middle aged men and 9% of young-middle aged women are affected by sleep disordered breathing, In older adults, these rates rise to approximately 70% in men and 56% in women (Lin, 2008). Additional limitations of the ADHRE registry include the non-standardized scoring sets among the participating providers and data limited to one year post-implantation.

As more literature regarding upper airway stimulation is published, the primary concerns regarding the current evidence have not been addressed. The current evidence consists of prospective, retrospective, observational or case series studies, which did not include a comparative group (Gillespie, 2017; Heiser, 2017). RCTs reporting long-term outcomes would provide the means to evaluate the net health outcomes of hypoglossal nerve stimulation compared to the standard established therapies.

Description of Sleep Apnea

OSA syndrome affects over 18 million people in the United States. Many of these people have never had a proper diagnosis. OSA is characterized by an interruption of breathing during sleep, due to extra or loose tissue in the upper airway that collapses into the air passage with the effort of inhalation. This is often linked to obesity and decreased muscle tone due to aging. When the airway becomes blocked, a drop in blood oxygen content can occur which is detected by the brain, causing the individual to wake just enough to tighten the airway muscles and allow breathing to then resume. This may occur several hundred times in one night. OSA can cause many symptoms, such as depression, irritability, sexual dysfunction, learning and memory difficulties, and falling asleep while at work or driving. OSA is recognized as a contributor or primary mediators in several cardiovascular conditions, including atrial fibrillation, stroke, myocardial infarction and sudden cardiac death. Continuous positive airway pressure (CPAP) is considered the gold standard treatment for OSA. However, compliance is an issue with an estimated 40-70% of individuals using CPAP less than a therapeutic amount of time (Soose, 2016). In addition, there is a subset of individuals which do not respond adequately to CPAP therapy. Surgical treatment is considered a second-line therapy following failure of PAP trial in most cases. The most appropriate surgical treatment requires that a thorough evaluation be done to locate the precise area of obstruction as obstruction can occur at the retropalatal or the retrolingual area or in both areas (Aurora, 2010).

Description of OSA Treatments

UPPP is a surgical procedure involving the removal of excessive tissue in the retropharyngeal area, including tonsils and uvula, to widen the area to increase airflow. Since its inception, a number of modifications have been developed including lateral pharyngoplasty, uvulopalatal flap, Z-palatopharyngoplasty, palatal advancement pharyngoplasty, expansion sphincter pharyngoplasty, relocation pharyngoplasty and zed-plasty. Complications of this surgery may include swelling, pain, infection, bleeding, reflux of secretions into the nose, and a nasal quality to the voice. This procedure typically requires an inpatient stay and is used for the treatment of severe OSA. This procedure can be used alone or when there is multilevel obstruction, as part of a staged procedure.

Hyoid myotomy is a surgical procedure that involves movement of the hyoid bone in the neck. The hyoid bone is a c-shaped bone located above the Adam’s apple, to which the base of the tongue and other soft tissues of the throat are anchored. Hyoid myotomy involves the surgical detachment of these soft tissues from the hyoid bone and then reattachment in a manner that places increased tension on the tissues. This increased tension is intended to decrease soft tissue collapse of the upper airway that is characteristic of sleep apnea.

Genioglossus advancement is a surgical procedure that involves alteration of the anchor point for the genioglossus muscle of the tongue. This point is located on the inside of the lower jaw. During this procedure, the area of bone surrounding the anchor point is separated from the rest of the jaw bone and pulled outward, drawing the tongue away from the back of the throat. This serves to prevent the base of the tongue from blocking the upper airway during sleep.

Jaw realignment surgery is an extensive procedure, in which the upper and lower jaws are advanced several millimeters to improve airflow through the back of the throat. Several surgeries may be required. Persons undergoing jaw realignment surgery typically also undergo orthodontic therapy to correct changes in tooth alignment, associated with the surgery. Change in facial appearance is common in this type of surgery. Other side effects of the procedure include swelling, pain, dental mal-alignment requiring correction, and bleeding.

Many other surgical methods have been proposed for the treatment of OSA, which use various methods of removing or ablating excess tissue from the upper airway, predominantly the soft palate and in some cases the base of the tongue. Of these proposed methods, radiofrequency ablation techniques use high frequency radio waves to destroy tissue of the soft palate, nasal turbinates and/or base of the tongue to decrease excess tissues in the back of the throat. Radiofrequency ablative techniques include RFVTR, Coblation and Somnoplasty. Persons undergoing these procedures frequently require multiple treatments for adequate results. Another category of treatment that aims to remove excess tissue from the upper airway uses heat from either a laser or an electrocautery device to destroy tissue of the soft palate. The two approaches currently available that use this method are LAUP and CAPSO.

Another surgical method proposed for the treatment of OSA is the AIRvance (formerly the Repose) system. This system involves the insertion of a bone screw into the inside of the lower jaw. A cable is then threaded through the base of the tongue and anchored to the bone screw. This system is used to prevent the base of the tongue from falling into the airway, which can be a cause of some OSA symptoms. Similar to the AIRvance System, the ENCORE Tongue Suspension System utilizes a suture loop which is created in the posterior section of the tongue base and is then tensioned and anchored with a bone screw placed midline on the infero-posterior surface of the mandible. The ENCORE System was cleared by the FDA on July 1, 2011 through the 510(k) approval process as an intraoral device for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of mild or moderate OSA and/or snoring. The literature, to date, has been limited by small numbers of subjects, and a literature review conducted by the manufacturer of the ENCORE System concluded that the evidence currently available has been graded as low level evidence regarding safety and efficacy (Sezen, 2011).

Injection snoreplasty has been proposed as a treatment of both snoring and OSA. This procedure, frequently done in one to three separate treatments, involves injection of a chemical (Sotradecol) into the soft palate and uvula. Sotradecol is known as a sclerotherapy agent, and causes scarring via an inflammatory reaction in the tissues to which it is exposed. The scarring caused by Sotradecol causes the flabby loose tissue in the back of the throat to shrink and tighten, which is proposed to open the upper airway and decrease the symptoms of snoring and OSA.

The Pillar Palatal Implant System (Restore Medical, Inc. St. Paul, MN) consists of three narrow threads of braided polyester slightly less than an inch in length that are inserted under the skin of the soft palate, using a delivery tool. One is placed in the midline and one each in right and left lateral locations. The procedure can be performed in the physician’s office under local anesthesia, and over the next few weeks, scar tissue grows around the threads further stiffening the palate. The implants are designed to be permanent structures but can be removed if necessary for reasons of infection or instability. Post-operative pain is claimed to be mild and short lived with rapid resumption of normal activities and diet (unlike LAUP and RFVTR). The Pillar system received market clearance from the U.S. Food & Drug Administration in 2003.

Hypoglossal nerve stimulation devices consist of three components: a pulse generator, a breathing sensor lead which monitors and senses breathing patterns, and a stimulation lead which delivers mild stimulation to the genioglossus nerve. This stimulation causes enlargement and stabilization of both the retrolingual airway and the retropalatal space and is designed to work in synchrony with respiration to allow for unobstructed inspiration. A small remote allows the individual to turn the device on each night and turn it off upon awakening. While the Inspire device is currently the only FDA approved device, a second device, THN Sleep Therapy (ImThera, San Diego, CA) is undergoing clinical trials. Limitations of this therapy include MRI incompatibility and the need for three external incisions during implantation (Soose, 2016).

Proposed Benefits

The goal of all sleep disorder diagnostic procedures is to correctly identify a specific sleep disorder(s), in order to render proper treatment(s). Such treatment may alleviate sleep disorder symptoms and/or causes and allow the individual to achieve healthy sleep patterns.

Potential Risks

The level of risk associated with the various methods of OSA treatment varies dependent upon the level of invasiveness. The use of oral appliances poses little risk, but proper fitting should be done to assure optimal efficacy. The risks associated with CPAP and its derivatives are not life threatening, but include disturbed sleep until the user is acclimated to the device.

Various surgical treatments for OSA all include the standard risks associated with all surgical treatments, including infection, bleeding, pain and discomfort. Not all procedures are guaranteed to be 100% successful, and results may vary. All of these surgeries result in permanent reconfiguration of the anatomical position of the upper airway, which may have unintended consequences. Persons undergoing jaw realignment should be especially aware that this surgery will most likely affect their appearance.

Apnea-Hypopnea index (AHI) or Respiratory disturbance index (RDI): A measure of apnea severity defined by the total number of episodes of apnea or hypopnea during a full period of sleep divided by the number of hours asleep. For the purposes of this document, the terms AHI and RDI are interchangeable, although they may differ slightly in clinical use. An AHI/RDI greater than 30 is consistent with severe OSA. In some cases, respiratory effort-related arousals (or RERAS) are included in the RDI value. These RERA episodes represent EEG arousals associated with increased respiratory efforts but do not qualify as apneic or hypopneic episodes because of the absence of their defining air flow changes and/or levels of oxygen desaturation.

Central sleep apnea (CSA): A condition that is caused by decreased respiratory center output in the brain. This sleep apnea syndrome is not as common as OSA but may be associated with similar symptoms.

Continuous positive airway pressure (CPAP): This is a noninvasive treatment for OSA that involves delivery of pressurized air during sleep through a device that snugly covers the nose. The appropriate setting for standard CPAP treatment is determined during a titration sleep study.

Obstructive sleep apnea (OSA): This is a form of sleep disturbance, which occurs as the result of a physical occlusion of the upper airway during sleep, which interferes with normal breathing. The occlusion is usually in the back of the tongue and/or flabby tissue in the upper airway. This condition is associated with frequent awakening and often with daytime sleepiness.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; for the following diagnosis, or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

When services are also Not Medically Necessary:

When services are Investigational and Not Medically Necessary:
For the procedures listed above, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are Investigational and Not Medically Necessary:

When services are also Investigational and Not Medically Necessary:

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81. Walker RP, Levine HL, Hopp ML, Greene D. Extended follow-up of palatal implants for OSA treatment. Otolaryngol Head Neck Surg. 2007; 137(5):822-827.
82. Wassmuth Z, Mair E, Loube D, Leonard D. Cautery-assisted palatal stiffening operation for the treatment of obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. 2000; 123(1 Pt 1):55-60.
83. Watanabe T, Kumano-Go T, Suganuma N, et al. The relationship between esophageal pressure and apnea hypopnea index in obstructive sleep apnea-hypopnea syndrome. Sleep Res Online. 2000; 3(4):169-172.
84. Wilhelmsson B, Tegelberg A, Walker-Enstrom ML, et al. A prospective randomized study of a dental appliance compared with uvulopalatopharyngoplasty in the treatment of obstructive sleep apnea. Acta Otolaryngol. 1999; 119(4):503-509.
85. Withrow K, Evans S, Harwick J, et al. Upper airway stimulation response in older adults with moderate to severe obstructive sleep apnea. Otolaryngol Head Neck Surg. 2019; 161(4):714-719.
86. Woodson BT. Transpalatal advancement pharyngoplasty. Oper Tech Otolaryn. 2007; 18(1):11-16.
87. Woodson BT, Derowe A, Hawke M, et al. Pharyngeal suspension suture with repose bone screw for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000; 122(3):395-401.
88. Woodson BT, Gillespie MB, Soose RJ, et al.; STAR Trial Investigators; STAR Trial Investigators. Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect. Otolaryngol Head Neck Surg. 2014; 151(5):880-887.
89. Woodson BT, Nelson L, Mickelson S, et al. A multi-institutional study of radiofrequency volumetric tissue reduction for OSAS. Otolaryngol Head Neck Surg. 2001; 125(4):303-311.
90. Woodson BT, Robinson S, Lim HJ. Transpalatal advancement pharyngoplasty outcomes compared with uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg. 2005; 133(2):211-217.
91. Woodson BT, Soose RJ, Gillespie MB, et al.; STAR Trial Investigators. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngol Head Neck Surg. 2016; 154(1):181-188.
92. Woodson BT, Steward DL, Mickelson S, et al. Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2010; 143(4):585-590.
93. Woodson BT, Steward DL, Weaver EM, Javaheri S. A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg. 2003; 128(6):848-861.
94. Woodson BT, Strohl KP, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: 5-year outcomes. Otolaryngol Head Neck Surg. 2018; 159(1):194-202.
95. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004; 291(16):2013-2016.
96. Zaghi S, Holty JE, Certal V, et al. Maxillomandibular advancement for treatment of obstructive sleep apnea: A meta-analysis. JAMA Otolaryngol Head Neck Surg. 2016; 142(1):58-66.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS). Position Statements: Available at: http://www.entnet.org/content/position-statements. Accessed on July 20, 2020.
   • Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (OSA). November 2019.
   • Midline Glossectomy for OSA. September 28, 2013.
   • Submucosal Ablation of the Tongue Base for OSAS. December 8, 2012.
   • Surgical Management of Obstructive Sleep Apnea. March 2, 2014.
   • Tongue Based Procedures. July 31, 2014.
   • Tongue Suspension. September 17, 2016.
   • Treatment of Obstructive Sleep Apnea. November 2019.
   • Uvulopalatopharyngoplasty. November 2019.
2. American Association of Oral and Maxillofacial Surgeons (AAOMS). Criteria for Orthognathic Surgery. https://www.aaoms.org/docs/practice_resources/clinical_resources/ortho_criteria.pdf. Accessed on July 20, 2020.
3. American College of Physicians (ACP). Management of Obstructive Sleep Apnea in Adults. October 1, 2013. Available at: https://annals.org/aim/fullarticle/1742606/management-obstructive-sleep-apnea-adults-clinical-practice-guideline-from-american. Accessed on July 20, 2020.
4. Aurora RN, Casey KR, Kristo D, et al. American Academy of Sleep Medicine. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010; 33(10):1408-1413. Available at: http://www.aasmnet.org/Resources/PracticeParameters/PP_SurgicalModificationsOSA.pdf. Accessed on July 20, 2020.
5. 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. 2010; 33(10):1396-1407.
6. Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009; 5(3):263-276. Available at: http://www.aasmnet.org/Resources/ClinicalGuidelines/OSA_Adults.pdf. Accessed on July 20, 2020.
7. Giralt-Hernando M, Valls-Ontañón A, Guijarro-Martínez R, et al. Impact of surgical maxillomandibular advancement upon pharyngeal airway volume and the apnoea-hypopnoea index in the treatment of obstructive sleep apnoea: systematic review and meta-analysis. BMJ Open Respir Res. 2019; 6(1):e000402.
8. Marcus CL, Brooks LJ, Draper KA, et al; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012; 130(3):e714-755.
9. National Institutes of Health (NIH). Clinical Trials. Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry. NCT02907398. Available at: https://clinicaltrials.gov/ct2/show/NCT02907398. Accessed on July 24, 2020.
10. Qaseem A, Holty JC, Owens DK, et al. American College of Physicians (ACP). Management of obstructive sleep apnea in adults: a Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2013; 159(7):471-483. Available at: http://annals.org/article.aspx?articleid=1742606. Assessed on July 20, 2020.
11. Randerath WJ, Verbraecken J, Andreas S, et al. European Respiratory Society task force on non-CPAP therapies in sleep apnea. Non-CPAP therapies in obstructive sleep apnea. Eur Respir J. 2011; 37(5):1000-1028.
12. Somers VK, White DP, Amin R, et al. Sleep apnea and cardiovascular disease: an American Heart Association/American College of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. J Am Coll Cardiol. 2008; 52(8):686-717.
13. Strollo PJ, Jr., Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014; 370(2):139-149.
14. Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev. 2005;(4):CD001004.
15. U.S. Food and Drug Administration (FDA) Center for Devices and Radiologic Health (CDRH) 510 (k) Premarket Notification Database.
    • ENCORE^™ Tongue Suspension System. Summary of Safety and Effectiveness. No. K111179. Rockville, MD: FDA. July 1, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111179.pdf. Accessed on July 20, 2020.
    • Pillar^™ Palatal Implant System. Summary of Safety and Effectiveness. No. K040417. Rockville, MD: FDA. July 28, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040417.pdf. Accessed on July 27, 2020.
    • Inspire Upper Airway Stimulation (UAS). Summary of Safety and Effectiveness. No. P130008. Rockville, MD: FDA. April 30, 2014. https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130008B.pdf. Accessed July 27, 2020.

1. Surgery for Obstructive Sleep Apnea. American Academy of Otolaryngology - Head and Neck Surgery. Available at: http://www.entnet.org/node/1459. Accessed on July 27, 2020.
2. Sleep Apnea. National Heart, Lung, and Blood Institute. Available at: https://www.nhlbi.nih.gov/health-topics/sleep-apnea. Accessed on July 27, 2020.

AIRvance System
Apnea/Hypopnea Index (AHI)
Cautery-Assisted Palatal Stiffening Operation (CAPSO)
Coblation
ENCORE Tongue Suspension System
Genioglossal (Genioglossus) Advancement
Inspire Upper Airway Stimulation system
Laser-Assisted Uvulopalatopharyngoplasty (LAUP)
Obstructive Sleep Apnea
Pillar Implant
Radiofrequency Ablation of Palatal Tissues and the Base of Tongue
Repose System
RF Thermal Ablation
Somnoplasty System 
Uvulopalatopharyngoplasty

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.