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The purpose of the review is to provide background on palatal anatomy and phenotypes to better model the complex upper airway structure. Review of the literature identifies limited data on upper airway phenotypes and the associated palatal anatomy. The majority of literature evaluates sites of obstruction based on sedated endoscopy without describing the pharyngeal lumen and its characteristics. Upper airway anatomy is associated with different patterns and airway configurations. These can be described and may represent specific phenotypes. Additional research is needed to associate phenotypes with disease and treatment outcomes.

Upper airway stimulation is a powerful tool in the sleep surgeon’s arsenal for dealing with obstructive sleep apnea. With long-term data now available on patient outcomes, there is a greater understanding of the complications, long-term effects, and stability of the improvement in clinical parameters. As a result, we have improved our ability to recognize difficulties with the device and improve results. This chapter covers both routine follow-up (frequency of visits, device checks, criteria for repeat sleep studies, monitoring of patient subjective and objective parameters, monitoring of adverse events, and long-term device maintenance) and complexities that can arise years out from the original surgery (suboptimal clinical response to upper airway stimulation, weight gain, comorbid medical conditions, surgical complications in the long-term setting, device malfunction, complex device programming, complex polysomnographic titration, awake vs. sleep endoscopy for titration, and complex clinical profiles).

OBJECTIVES/HYPOTHESIS To determine the association between findings of blinded reviews of preoperative drug-induced sleep endoscopy (DISE) and outcomes of hypoglossal nerve stimulation (HNS) for obstructive sleep apnea (OSA). STUDY DESIGN Cohort study. METHODS A retrospective, multicenter cohort study of 343 adults who underwent treatment of OSA with HNS from 10 academic medical centers was performed. Preoperative DISE videos were scored by four blinded reviewers using the VOTE Classification and evaluation of a possible primary structure contributing to airway obstruction. Consensus DISE findings were examined for an association with surgical outcomes based on therapy titration polysomnogram (tPSG). Treatment response was defined by a decrease of ≥50% in the apnea-hypopnea index (AHI) to

The goal of this review is to advance the understanding of the muscular and soft tissue palatal anatomy as it relates to palatal surgery for sleep apnea and the phenotypic variations that generate the shape and collapsibility of the retropalatal airway. Anatomically, the soft palate has both a proximal and distal segments separated by the palatal genu. The proximal palatal segment has a variable angle from the hard palate (ie, alpha angle) determined by the position and length of the levator veli palatini muscle. The palatopharyngeus muscle (PP) is a major defining element of the palate and lateral pharyngeal wall and forms the medial wall of the lateral palatal space. It is composed of two divisions: the longitudinal palatopharyngeus fasciculi which acts to elevate the pharynx and depress the soft palate and the transverse palatopharyngeus fascicle (Passavant's ridge) which function is a nasopharyngeal sphincter. The lateral palatal space incorporates the supra-tonsilar fat, and is bounded by muscles that determine the structure of the palate and associated lateral pharyngeal walls. Understanding of palatal muscles and pharyngeal airway phenotypes provides insight into the steps and mechanisms of pharyngoplasty procedures. Level of evidence N/A.

Objective To evaluate the association between findings of blinded reviews of preoperative drug-induced sleep endoscopy (DISE) examinations using the VOTE Classification and obstructive sleep apnea (OSA) surgical outcomes in a large multicenter, international cohort. Methods Retrospective, multi-center cohort study of adults without tonsillar hypertrophy who underwent pharyngeal surgery for OSA. The study included only participants without enlarged tonsils. Four independent reviewers performed blinded review of preoperative DISE videos using the VOTE Classification system and scoring of a primary structure contributing to airway obstruction. DISE findings were examined for an association with surgical outcomes with univariate analyses and multiple regression. Results Two hundred seventy-five study participants were included from 14 centers. Mean age was 51.4 ± 11.8 years, and body mass index was 30.1 ± 5.2 kg/m2 . There was moderate interrater reliability (kappa = 0.40-0.60) for DISE findings. Oropharyngeal lateral wall-related obstruction was associated with poorer surgical outcomes (adjusted odds ratio (AOR) 0.51; 95% CI 0.27, 0.93). Complete tongue-related obstruction was associated with a lower odds of surgical response in moderate to severe OSA (AOR 0.52; 95% CI 0.28, 0.98), with findings that were similar but not statistically significant in other analyses. Surgical outcomes were not clearly associated with the degree and configuration of velum-related obstruction or the degree of epiglottis-related obstruction. Surgical response was associated with tonsil size and body mass index (inversely). Conclusion DISE findings concerning the oropharyngeal lateral walls and tongue may be the most important findings of this evaluation technique. Level of evidence 2B Laryngoscope, 129:761-770, 2019.

Objective: To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design: A multicenter prospective cohort study. Setting: Industry-supported multicenter academic and clinical trial. Methods: From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index 2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results: Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI 50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions: Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

Objective Selective upper airway stimulation is now well-established in the United States and in several European countries, with more than 1,000 patients implanted since U.S. Food and Drug Administration approval in April 2014. The authors herein, all head and neck surgeons, account for approximately one of every five implants completed to date. Several of the authors also provide comprehensive longitudinal care of their patients as dual-specialty sleep medicine physicians. Study Design Multi-center, retrospective clinical analysis. Methods More than 300 implants have been evaluated and reviewed in five different implant centers (Germany, United States). Results This analysis shares tips and techniques from the collective experiences with more than 300 implants, which can help newer implanters learn vicariously both for standard practices in executing routine implants through activation and, importantly, for working through more challenging encounters with anatomy, special patient phenotypes, system testing, and troubleshooting. Conclusion These tips should help new implanters handle most of the situations arising during implantation and avoid common pitfalls. Laryngoscope, 2017

Objectives: Analyze the obstructive sleep apnea (OSA) treatment history in a group of participants who enrolled in a hypoglossal nerve stimulation trial. Methods: Moderate-severe OSA patients with difficulty adhering to CPAP presented for enrollment in a multicenter trial. Self-reported history on prior OSA medical therapy was collected at enrollment, including OSA diagnosis date, CPAP start and stop dates, oral appliance trial, and reasons for discontinuation or non-adherence. Results: The cohort consisted of 929 participants, 83% male, with a mean age (53.9 ± 10.5) years. Ninety percent (n = 835) had complete CPAP information including 47% (n = 435) who discontinued therapy prior to enrollment and 43% (n = 400) who were still attempting CPAP but had inadequate adherence. Abandonment rates were 60% at 1-year, 73% at 3-years, and 86% at 5-years. Oral appliance therapy was attempted by 171 patients for mean (1.8 ± 2.3) years, with 81% abandonment at 1 year, 89% at 3-years, and 94% at 5-years. Conclusions: In this CPAP-refractory cohort, high rates of CPAP abandonment were reported in the first several years with approximately half of the participants not receiving any treatment despite being diagnosed for >5 years. Close clinical follow-up and consideration of alternative treatment options is indicated in all OSA patients in order to ensure adequate longitudinal care. Keywords: Upper airway stimulation, Hypoglossal nerve stimulation, STAR trial, Obstructive sleep apnea, CPAP failure

Objective: To determine the level of agreement among experienced operators of candidacy for upper airway stimulation (UAS) based on evaluation of drug-induced sleep endoscopy (DISE). Methods: The trial was designed as a single-blinded cross-sectional study. Four otolaryngologists with extensive DISE experience were given 63 video clips from the STAR trial video library. These videos were graded using the VOTE classification. Percentage agreement and Cohenâs κ (for inter-rater reliability) were calculated between pairs of reviewers, assessing palatal complete concentric collapse (CCC) and determining UAS eligibility. Subjects were also grouped based on collapse severity for each reviewer. Results: The reviewers had excellent (approximately 90%) agreement on findings at the level of the soft palate and tongue base. The inter-rater reliability for palatal CCC ranged from moderate to substantial. The agreement on determining the criteria for UAS implantation ranged from poor to moderate. All 4 upper airway structures as classified by the criteria of the VOTE were graded by all the reviewers as contributing to obstruction in a majority of subjects who were performed via application of DISE. Conclusion: Application of DISE remains a subjective examination, even among those experienced operators, therefore more studies need to be performed for evaluation of improvement in inter-rater reliability after implantation of training videos. Keywords: Drug-induced sleep endoscopy, Drug-induced sedation endoscopy, Upper airway stimulation, Sleep-disordered breathing, Obstructive sleep apnea, Inter-rater reliability

Objective: To assess patient-based outcomes of participants in a large cohort study—the STAR trial (Stimulation Therapy for Apnea Reduction)—48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea.Study Design: A multicenter prospective cohort study. Setting: Industry-supported multicenter academic and clinical setting. Subjects: Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods: A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline.Results: A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced (P =.01), and sleep-related quality of life as measured by FOSQ significantly improved (P =.01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion: Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.

Surgical techniques for obstructive sleep apnea syndrome (OSAS) constantly evolve. This study aims to assess the effectiveness and safety of a new surgical approach for an OSAS pharyngoplasty with a dorsal palatal flap expansion (PDPFEx). A total of 21 participants (mean age 49.9, mean BMI 32.5) underwent a type III sleep study, an endoscopy of the upper airways, a filled medical history, a visual analog scale for snoring loudness, an Epworth Sleepiness Scale, and a Short Form Health Survey-36 questionnaire. A follow-up re-evaluation was performed 11 ± 4.9 months post-operatively. The study group (4 with moderate, 17 with severe OSAS) showed an improvement in all measured sleep study characteristics (p &lt, 0.05), apnea-hypopnea index (pre-median 45.7 to 29.3 post-operatively, p = 0.009, r = 0.394), oxygen desaturation index (pre-median 47.7 and 23.3 post-operatively, p = 0.0005, r = 0.812), mean oxygen saturation (median 92% pre-operatively and median 94% post-operatively, p = 0.0002, r = 0.812), lowest oxygen saturation (p = 0.0001, r = 0.540) and time of sleep spent with blood oxygen saturation less than 90% (p = 0.0001, r = 0.485). The most commonly reported complications were throat dryness (11 patients) and minor difficulties in swallowing (5 patients transient, 3 patients constant). We conclude that a PDPFEx is a promising new surgical method, however, further controlled studies are needed to demonstrate its safety and efficacy for OSAS treatment in adults.

Obstructive sleep apnea syndrome (OSA) is a multi-factorial disorder, with quite complex endotypes, consisting of anatomical and non-anatomical pathophysiological factors. Continuous positive airway pressure (CPAP) is recognized as the first-line standard treatment for OSA, whereas upper airway (UA) surgery is often recommended for treating OSA patients who have refused or cannot tolerate CPAP. The main results achievable by the surgery are UA expansion, and/or stabilization, and/or removal of the obstructive tissue to different UA levels. The site and pattern of UA collapse identification is of upmost importance in selecting the customized surgical procedure to perform, as well as the identification of the relation between anatomical and non-anatomical factors in each patient. Medical history, sleep studies, clinical examination, UA endoscopy in awake and drug-induced sedation, and imaging help the otorhinolaryngologist in selecting the surgical candidate, identifying OSA patients with mild UA collapsibility or tissue UA obstruction, which allow achievement of the best surgical outcomes. Literature data reported that the latest palatal surgical procedures, such as expansion sphincter palatoplasty or barbed reposition palatoplasty, which achieve soft palatal and lateral pharyngeal wall remodeling and stiffening, improved the Apnea Hypopnea Index, but the outcome analyses are still limited by methodological bias and the limited number of patients’ in each study. Otherwise, the latest literature data have also demonstrated the role of UA surgery in the improvement of non-anatomical factors, confirming that a multidisciplinary and multimodality diagnostic and therapeutical approach to OSA patients could allow the best selection of customized treatment options and outcomes.

Selective upper airway stimulation has been established as an additional treatment for obstructive sleep apnea (OSA). Essential for the treatment is the precise placement of the cuff electrode for select branches of the hypoglossal nerve, which innervate the protrusors and stiffeners of the tongue. A direct approach to the distal hypoglossal nerve has been established to achieve this goal. For surgeons, detailed knowledge of this anatomy is vital. Another decisive step is the placement of the sensing lead between the intercostal muscles. Also, the complexity of follow-up care postoperatively should be kept in mind. The aim of this article is to provide the latest knowledge on the neuroanatomy of the hypoglossal nerve and to give surgeons a step-by-step guide on the current operative technique. Laryngoscope, 126:S12-S16, 2016.

Selective stimulation of the upper airway is a new therapy for obstructive sleep apnea. The aim of the study was to determine if a selective nerve integrity monitoring (NIM) system could aid in precise placement of the cuff electrode in selective upper-airway stimulation.Single-center, prospective clinical trial.Twenty patients who received a selective upper-airway stimulation system (Inspire Medical Systems, Maple Grove, MN) were implanted by using a NIM system. The tongue motions were recorded during surgery and 2 months postoperatively from the transoral view and by transnasal endoscopy.All patients exhibited consistent protrusion at tongue front and tongue base. The nerve monitoring system helped to place the cuff electrode around the protrusion and stiffening branches, while excluding the retractor branches of the hypoglossal nerve.This report demonstrated a novel use of a NIM system to identify the functional separation between inclusion and exclusion branches of the hypoglossal nerve for implantation of a selective upper-airway stimulation system.4. Laryngoscope, 126:2852-2858, 2016.

A variety of sleep disturbances and disorders can be exhibited by mild traumatic brain injury (mTBI) patients, both as acute and chronic sequelae post-injury, and can differ in presentation from those of more severe TBI patients. These disorders require proper recognition and diagnosis by practitioners. While study of mTBI-related sleep disorders has increased in recent years, much remains to be understood concerning the prevalence, diagnosis, and treatment of these disorders among different populations. Particularly, important areas for further study include the long-term effects of mTBI on sleep, pharmacologic treatment of mTBI-related sleep disorders, the pathophysiology of sleep disruption in mTBI and the interplay of sleep disorders and chronic pain and psychiatric disorders among mTBI patients.

Citation: Garcia GJM, Woodson BT. The collapsing anatomical structure is not always the primary site of flow limitation in obstructive sleep apnea. J Clin Sleep Med. 2020;16(3):345–346.

This study seeks to determine the success rates of the expansion sphincter pharyngoplasty and its variants on the treatment of obstructive sleep apnea (OSA). Systematic review and meta-analysis. Two independent searches of MEDLINE, Google Scholar, Cochrane Library and Evidence Based Medicine Reviews to identify publications relevant to OSA and expansion pharyngoplasty. All relevant studies published before 31 March 2015 were included. Five studies were included in the systematic review and meta-analysis. The numbers of patients in each paper ranged from 10 to 85 (total = 155), and mean age ranged from 8 to 56 years. Substantial and consistent improvement in PSG outcomes were observed post-expansion pharyngoplasty patients, with or without multilevel surgery groups. The results showed that the expansion pharyngoplasty technique has significantly lower AHI than control group [Standardised mean difference -7.32, 95 %CI (-11.11, -3.52), p = 0.0002]; however, substantial heterogeneity between these studies were observed. The mean pre-operative AHI (in the five papers) improved from 40.0 ± 12.6 to 8.3 ± 5.2 post-operatively. The overall pro-rated pooled success rate for all the patients was 86.3 %. The expansion pharyngoplasty is effective in the management of patients with OSA.

Uvulopalatopharyngoplasty (UPPP) has been the most commonly performed procedure for obstructive sleep apnea. However, high failure rates of this procedure, which can reach 50%-70% of the cases, have led to various modifications in the UPPP technique to address persistent obstruction after traditional UPPP surgery. Expansion sphincteroplasty was developed as a modification of UPPP to address lateral wall collapse proximal to the free margin of the palate and transpalatal advancement pharyngoplasty was developed as a modification of UPPP to address more proximal anterior posterior narrowing of the retropalatal segment. Transpalatal advancement has also been shown to address proximal lateral wall airway narrowing.

Objective: Pilot study to examine the effect of radiofrequency ablation (RFA) of the lateral palatal fat pad in patients with socially-disruptive snoring. Method: Snoring outcomes and complications were compared between a group of patients with treated with RFA ablation of the lateral soft palate fat pad with or without inferior turbinate reduction (8 patients) and another group undergoing inferior turbinate reduction alone (12 patients). Results: Snoring loudness and bothersomeness improved in the palate but not inferior turbinate group. Pain was mild and no major complications were observed. Conclusion: The study supports RFA ablation of the lateral palatal space as a potential low morbidity procedure for snoring. Keywords: Snoring, Radiofrequency, Somnoplasty, Radiofrequency ablation, Inferior turbinate reduction, Turbinoplasty

Objectives/Hypothesis To describe and to assess reproducibility of a method to model the lumen of the pharyngeal airway using anatomic structures. Study Design Single-center, institutional review board-approved retrospective case series. Methods Multiple structural landmarks (hard palate, palatal aponeurosis, genu, velum, and lateral wall; pharyngeal and vallecular tongue base; and epiglottis) were used as reference points to score the associated airway. These characteristics were then combined to create a luminal model of the pharyngeal airway. Retrospective assessment by two independent observers of 117 sedated endoscopies from a convenience sample (81% male, aged 51.4 years; apnea hypopnea index 38.5 events/hr) was performed. Results Scoring of individual landmarks demonstrated a good or better agreement (kappa of 0.42–0.79). Agreement on whether the airway was constricted/obstructed was very high (kappa > 0.77). Based on differences in airway measures at different levels, multiple patterns of luminal shape and narrowing were observed. The upper pharyngeal lumen was classified into different shapes based on findings at different levels of the soft palate (oblique, 52%; intermediate, 23%; vertical, 25%). Similarly, the lower pharynx was classified into three shapes based on the structure of the tongue. Conclusion Multiple pharyngeal luminal configurations describing airway phenotypes can be described using landmarks identifiable on endoscopy. Level of Evidence 4. Laryngoscope, 125:1233–1238, 2015

The failure of traditional upper airway surgery such as uvulopalatopharyngoplasty has been attributed to lower airway obstruction related to base of tongue collapse. Multiple procedures, including glossectomy, tongue base radiofrequency, genioglossus advancement, and tongue suspension techniques, have been advocated to improve success rates. No consensus exists on which subsets of patients are best treated by individual approaches and direct comparative data are lacking. The selection of procedures must be based on individual patient needs and the relative potential benefits and risks.

Economic and access issues are driving the use of portable monitoring for primary diagnosis of obstructive sleep apnea (OSA) in selected adults. Its applicability has been demonstrated for adults at high risk of sleep apnea, but many caveats and research questions remain. For technical reasons, most limited-channel diagnostic devices tend to underestimate the severity of the disease. In addition, portable monitoring is of little value for sleep disorders other than OSA and has not been advocated for children or the elderly. Similarly, auto-continuous positive airway pressure (APAP) is an alternative to in-laboratory continuous PAP titration. The cost-effectiveness of portable diagnostic testing and APAP titration in actual practice is yet to be determined, but will be a critical question in the years ahead. Future research should examine their use for extended populations, and the economic effect of these modalities, to determine the best use of these techniques as alternatives to traditional in-laboratory testing.

Traditional upper airway surgery directly modifies skeletal and soft tissue structures surrounding the airway to treat obstructive sleep apnea (OSA). Upper airway stimulation (UAS) attempts to treat upper airway obstruction and OSA by stimulating the hypoglossal nerve. The Inspire II implant has been approved for clinical UAS. Basic science data support that UAS prevents obstruction and improves airflow. Clinical results demonstrate that UAS improves respiratory sleep metrics and improves both objective and subjective self-reported sleep and quality-of-life outcomes. In a substantial number of individuals who meet inclusion criteria, UAS appears to be a viable, long-term, low-morbidity treatment of moderate-to-severe OSA.

The low success rates for current surgical treatments for obstructive sleep apnea highlight the need for new methods for treating the disorder. This manuscript describes the novel Inspire upper airway stimulation method that through stimulation of the hypoglossal nerve leads to concomitant contraction of the innervated tongue protrusor musculature and increased airway patency. Three components, a stimulating electrode lead, an implantable pulse generator, and a respiration sensing lead, are surgically implanted at 3 separate sites. Detailed descriptions of the surgical method and accompanying illustrations clarify the procedure. Finally, the protocols for activating and titrating the system are detailed. Preliminary clinical investigations on carefully selected patients suggest that the Inspire Upper Airway Stimulation system is an efficacious therapy for treating obstructive sleep apnea.

Obstructive sleep apnea syndrome (OSA) results from the interaction between a structurally small and vulnerable upper airway and loss of compensatory reflexes. Surgical treatment is indicated in patients who fail medical treatment and aims to reduce obstruction by increasing airway size and decreasing collapsibility. Common components of airway obstruction in obstructive sleep apnea are relative macroglossia and lingual tonsil enlargement, both of which are amenable to surgical reduction. A technique is described that uses transoral, angled lens, rigid fiber-optic scopes with video camera to provide visualization and a malleable plasma surgery tool for tissue removal. Using this technique as part of a multilevel surgical approach, the apnea-hypopnea index was significantly reduced. Postoperative morbidity was generally low and included postoperative pain, dysphagia, transient change in taste, and bleeding. Patients were monitored in the outpatient ward and were discharged the morning following surgery. No patient required tracheotomy.

Multiple palatopharyngoplasty techniques are available for reconstruction of the upper pharyngeal airway. To select appropriate procedures, the surgeon requires classification methods, but traditional staging systems only describe levels of obstruction and do not relate sufficient anatomical detail to specify an intervention. A method of awake, upper airway evaluation is described, which allows the surgeon to direct specific surgical procedures to particular luminal shapes and anatomical structures. Expansion sphincter pharyngoplasty is a procedure for treatment of lateral pharyngeal stenosis, where rotation of the palatopharyngeus muscle is performed to widen the pharynx and advance the soft palate anteriorly. Palatal advancement pharyngoplasty is a technique for treatment of posterior retro-palatal obstruction which results in anterior palatal advancement. Surgical techniques and management are described.

Obstructive sleep apnea (OSA) is a common condition that affects up to 24% of men and 9% of women. When untreated, OSA increases risk of cardiovascular morbidity and mortality, motor vehicle accidents, metabolic abnormalities, and cognitivedisturbances. Treatment is associated with improvement in daytime somnolence, neurocognitive function, hypertension, and left ventricular function, and a decrease in health care costs. Heightened awareness of effects of OSA on health has led to a burgeoning demand for diagnostic and therapeutic interventions.However, uncertainty and controversy surround many available options.

To test the hypothesis that uvulopalatopharyngoplasty (UPPP) improves sleep apnea-related quality of life (measured on the Functional Outcomes of Sleep Questionnaire [FOSQ]) at 3-month follow-up. Secondary objectives were to test (1) the stability of the outcomes at 6 months, (2) the effect on global sleep apnea quality-of-life change, and (3) the effect on sleep apnea symptoms.Multicenter, prospective, longitudinal case series.Diverse university- and community-based otolaryngology practices.The cohort included 68 patients from 17 practices, with a mean ± standard deviation age of 44 ± 12 years and mean apnea-hypopnea index of 35 ± 32 events/hour. All patients underwent UPPP, defined as an open procedure modifying the shape and size of the palate, pharynx, and uvula, with or without tonsillectomy. Baseline data were collected on site before surgery, and outcome data were collected by mail 3 and 6 months after surgery, with follow-up rates of 51% and 50%, respectively.FOSQ scores improved from 14.3 ± 3.4 (scale 5-20, normal ≥17.9) at baseline to 17.2 ± 2.7 at 3 months (mean improvement 2.9; 95% confidence interval, 1.8-4.0; P.001) and 17.5 ± 2.5 at 6 months (mean improvement 3.1; 95% confidence interval, 2.0-4.2; P.001). All quality-of-life and symptom measures improved significantly at 3 and 6 months (all P.05).This prospective, multicenter, university- and community-based study provides evidence that UPPP significantly improves disease-specific quality of life and sleep apnea symptoms in patients with sleep apnea. Validity may be limited by significant loss to follow-up and absence of an unoperated control group.

Sleep-disordered breathing a spectrum that ranges from snoring through disorder of increased airway resistance, to overt sleep apnea affects many clinical disease outcomes. Traditionally, disease outcomes have been measured by polysomnography, with the most common metric being the apnea hypopnea index (AHI). Multiple other clinical metrics are commonly used to assess the severity and impact of disease on important outcomes of obstructive sleep apnea (OSA). These allow assessment of sleepiness, quality of life, performance, and medical, especially cardiovascular outcomes. Currently the available metrics only partially explain the associated disease outcomes in different patients. This review highlights the available clinical, physiological and biomarker metrics in measuring OSA and associated co-morbidities and defines treatment goals.

Obstructive sleep apnea results from the combination of a structurally small upper airway combined with the loss of muscle tone during sleep. Most therapies aim to reduce apnea severity by increasing airway size and stability. Conceptually, upper airway surgery should be a highly effective method to treat obstructive sleep apnea and other forms of sleep disordered breathing. Although major reconstructive surgeries such as maxillomandibular advancement demonstrate high success rates, more limited forms of surgery often demonstrate significantly lower success rates. Reviews of such surgical procedures have uniformly ignored contributions of the structural effectiveness of surgery. The purpose of the review is to evaluate current knowledge of how surgery for OSA alters structure. The majority of data available on surgical outcomes involve uvulopalatopharyngoplasty. Data demonstrate that pre-morbid surgical anatomy and techniques have significant effects on ultimate outcomes. Further research on structural outcomes for palatopharyngoplasty, as well as other surgical procedures, is needed to improve clinical outcomes.

The Certification Examination in Sleep Medicine was administered in November 2007 for the first time under cosponsorship of five member boards of the American Board of Medical Specialties (ABMS)—the American Board of Internal Medicine (ABIM), which is the designated administrative board, the American Board of Family Medicine (ABFM), the American Board of Otolaryngology (ABOto), the American Board of Pediatrics (ABP), and the American Board of Psychiatry and Neurology (ABPN). Preceding this administration was a 28-year history of testing by the American Board of Sleep Medicine (ABSM), beginning in 1978 with an examination in clinical polysomnography, passed by 21 candidates, and ending with the 2006 ABSM examination. During the 28-year period ending with the 2006 ABSM examination, 3,445 individuals were certified as diplomates of the ABSM. For the 1978 examination, candidates answered written true-false questions and oral questions posed by an examiner. In 1980, candidates completed a two-part examination given on separate dates. The first part consisted of 3 sections of multiple-choice questions. Candidates who successfully passed the first part took the second part, in which they completed essays based on interpretation of polysomnograms and multiple sleep latency tests. By 1991, the second part had evolved into an examination that required short written answers instead of essays, and a computer-based presentation of polysomnogram samples in lieu of paper recordings was introduced in 2002. Eventually, in 2005, a single-day computer-administered examination consisting only of multiple-choice questions was utilized. This format was very similar to that used for the 2007 Certification Examination in Sleep Medicine.1 The American Academy of Sleep Medicine and the ABSM prepared the way for certification by ABMS member boards, applying for recognition of sleep medicine training by the Accreditation Council for Graduate Medical Education (ACGME) and taking a major role in seeking ABMS approval of the certification process.1 Accreditation requirements for sleep medicine training programs were established in 2004, and the ABMS approved sleep medicine certification in 2005, leading to development of the 2007 Certification Examination in Sleep Medicine.

To determine efficacy of Pillar palate implants for mild to moderate obstructive sleep apnea (OSA) syndrome.Multi-institution, randomized, double-blind, placebo-controlled study.One hundred patients with mild to moderate OSA and suspected retropalatal obstruction were randomly assigned treatment with three palatal implants or sham placebo.Final apnea-hypopnea index (AHI) increased for both groups at 3 months, correlating with increased percentage of supine sleep but was less in the implant group (P = 0.05). A clinically meaningful reduction in AHI (or =50% reduction to20) was more common in the implant group (26% vs 10%, P = 0.05). Significant differences were noted for changes in lowest oxyhemoglobin saturation (P = 0.007) and Functional Outcomes of Sleep Questionnaire (P = 0.05). Improvement in Epworth Sleepiness Score did not differ from that of sham (P = 0.62). Partial implant extrusion occurred in two patients (4%).Palate implants for mild to moderate obstructive sleep apnea demonstrated efficacy over placebo for several important outcomes measures with minimal morbidity, but overall effectiveness remains limited. Further study is needed.

Objective To describe upper airway collapse patterns observed on drug-induced sedation endoscopy (DISE) during screening for a clinical trial and to evaluate the impact of collapse patterns found on preoperative DISE on response rates to upper airway stimulation (UAS) therapy. Study Design Retrospective review of an ongoing prospective multi-institutional cohort study. Setting Twenty-two participating institutions of the STAR trial. Subjects and Method In total, 222 subjects were screened with DISE to determine eligibility for an implantable UAS device. Supine laryngoscopy was performed during moderate sedation (propofol and/or midazolam). Airway collapse pattern and severity were graded at 4 levels, including velum, oropharynx, tongue base, and epiglottis (VOTE classification). Patients with complete concentric collapse (CCC) at the velum were excluded from implantation. Results The CCC at the velum was observed in 52 (23%) of screened subjects, and these subjects were subsequently excluded from implantation. Of the 170 subjects without CCC at the velum, 126 (77%) underwent implantation: 121 (96%) had multilevel collapse and 5 (4%) had single-level collapse. When comparing preimplantation DISE findings, UAS responders at 12 months had lower baseline VOTE scores compared with therapy nonresponders. Conclusion Drug-induced sedation endoscopy is an efficient and safe method for determining UAS eligibility and has the potential to identify UAS nonresponders. Most patients had multilevel airway collapse, illustrating the limitations of single-level upper airway surgery in treating obstructive sleep apnea. Upper airway stimulation is effective therapy for most patients with multilevel airway collapse; however, patients with complete anterior-posterior or lateral soft palate and/or epiglottic collapse may be at increased risk of therapy failure.

Objective: To describe the long term (36 month) clinical and polysomnographic outcomes in an OSA cohort treated with cranial nerve upper airway stimulation. Methods: 126 participants were enrolled in a prospective phase III trial evaluating the efficacy of Inspire II (Inspire Medical Systems, Minnesota, USA). Prospective outcomes included AHI, ODI, side effects and self-reported measures including sleepiness (ESS), sleep related quality of life (FOSQ), and snoring, .Data was collected at baseline and t select time points post-device activation. . Results: 116 of 126 enrolled patients completed 36 month follow up evaluation per protocol. 98 patients additionally agreed to an interval 36 month PSG. Daily device usage was 81%. In the interim PSG group, 74% met the a priori definition of success with the primary outcomes of AHI and ODI improved from baseline to 12 and 36 months (32.0±11.8 to 15.3±16.1 and 11.5±13.9 and 28.9±18.2 to 14.0±15.6 and 9.1±11.7, all p

Obstructive sleep apnea (OSA) results from complex interactions between anatomy and physiology. A structurally small and abnormally collapsible upper airway predisposes to disease, and interacts with normal and pathologic physiologic mechanisms to determine severity of disease. Understanding the pathophysiology provides insight into airway collapse, and may improve treatment and lead to potential new medical and surgical treatments for OSA.

In this study, we assessed the efficacy of a new method (expansion sphincter pharyngoplasty [ESP]) to treat obstructive sleep apnea.We conducted a prospective, randomized controlled trial.Forty-five adults with small tonsils, body mass index less than 30 kg/m2, of Friedman stage II or III, of type I Fujita, and with lateral pharyngeal wall collapse were selected for the study.The mean body mass index was 28.7 kg/m2. The apnea-hypopnea index improved from 44.2 +/- 10.2 to 12.0 +/- 6.6 (P0.005) following ESP and from 38.1 +/- 6.46 to 19.6 +/- 7.9 in the uvulopalatopharyngoplasty group (P0.005). Lowest oxygen saturation improved from 78.4 +/- 8.52% to 85.2 +/- 5.1% in the ESP group (P = 0.003) and from 75.1 +/- 5.9% to 86.6 +/- 2.2% in the uvulopalatopharyngoplasty group (P0.005). Selecting a threshold of a 50% reduction in apnea-hypopnea index and apnea-hypopnea index less than 20, success was 82.6% in ESP compared with 68.1% in uvulopalatopharyngoplasty (P0.05).The ESP may offer benefits in a selected group of OSA patients.

Hypopharyngeal airway obstruction may result from abnormal or disproportionate tongue base anatomy or lingual tonsil hypertrophy. Partial glossectomy and lingual tonsillectomy may be difficult and excessively morbid procedures in the sleep apnea population. Techniques are described using plasma surgery tools, combined with endoscopy, that allow for improved visualization and more complete removal of lingual tonsils and low morbidity mucosal sparing excisional glossectomy.

The goal of surgery for obstructive sleep apnea is to reconstruct the upper airway to prevent obstruction during sleep. Unfortunately, traditional techniques suffer from technical failure. To better address technical failure, a method of reconstructing the upper pharynx by performing a posterior maxillary osteotomy and advancing the soft palate anteriorly (posterior palatal osteotomy and palatal advancement flap) is described. Results demonstrate both structural and clinical improvements compared to more traditional uvulopalatopharyngoplasty.

OBJECTIVE: To determine long-term effectiveness of multilevel (tongue and palate) temperature-controlled radiofrequency tissue ablation (TCRFTA) for patients with obstructive sleep apnea syndrome (OSAS). STUDY DESIGN AND SETTING: Prospective, 2-institution case series. Twenty-nine subjects with mild to moderate OSAS and who were at least 1 year from completion of multilevel TCRFTA were included, representing a subset of subjects who were enrolled in a previously published controlled trial. Exclusion criteria for this extended follow-up study included any additional treatment for OSAS after completion of TCRFTA. RESULTS: Median follow-up was 23 months. Daytime sleepiness and OSAS-related quality of life were significantly improved at extended follow-up (both P < 0.001). Median reaction time testing and apnea-hypopnea index (AHI) were also significantly improved at long-term follow-up (P 0.03 and 0.01). Body mass index was unchanged (P 0.94). CONCLUSIONS: Multilevel TCRFTA treatment of mild to moderate OSAS resulted in prolonged improvement in daytime somnolence, OSAS-related quality of life, psychomotor vigilance, and AHI in this group of subjects at extended follow-up. (Otolaryngol Head Neck Surg 2005;132:630-635.) Obstructive sleep apnea syndrome (OSAS) is thought to affect between 2% and 4% of adults, resulting in significant morbidity and mortality. 1 Morbidity results primarily from cardiovascular disease; quality of life deficits; and performance deficits caused by loss of alertness and daytime somnolence, increasing risk for motor vehicle accidents. 2 However, successful treatment of OSAS with mechanical devices or surgery has been shown to ameliorate these risks of OSAS. 3,4 Nasal continuous positive airway pressure (CPAP), a mechanical device, is an efficacious treatment for severe OSAS. However, long-term effectiveness is limited by inadequate treatment adherence in many patients, especially those with milder OSAS. 5 Other devices such as oral appliances are less efficacious than CPAP, and effectiveness is also dependent upon nightly adherence. 6 Surgical management of OSAS has the advantage of not being dependent upon nightly use of a device but often produces incomplete correction or relapse of symptoms over time. 7 Further, traditional operations are associated with significant perioperative morbidity. Temperature-controlled radiofrequency tissue ablation (TCRFTA) of the tongue base and palate has been shown to improve OSAS in a randomized sham-placebo‐ controlled trial with minimal morbidity. 8 Extended follow-up of patients undergoing tongue base TCRFTA for OSAS demonstrated persistent improvements in measures of general health status (short form36) and daytime sleepiness. 9 This study was designed to assess the long-term effectiveness of multilevel (tongue and palate) TCRFTA to improve quality of life, symptoms, reaction time, and physiology for patients with mild to moderate OSAS. Our hypothesis is that TCRFTA treatment provides long-term improvements in these outcomes, using validated measures.

The study goal was to determine the effectiveness of (1) multilevel temperature-controlled radiofrequency tissue ablation (TCRFTA) or (2) continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea syndrome (OSAS).We conducted a randomized, placebo-controlled, 2-site trial, comparing TCRFTA (n = 30) and CPAP (n = 30) with sham-placebo (n = 30) using intention-to-treat analysis.Compared with pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality of life (QOL), and subjective sleepiness (all P0.05). Compared with sham-placebo, TCRFTA improved QOL, airway volume, apnea index, and respiratory arousal index (all P0.05). TCRFTA side effects and complications were mild, temporary, and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared with sham-placebo (all P0.05). Significant differences were not seen between TCRFTA and CPAP outcomes.TCRFTA and CPAP each improve QOL for mild-moderate OSAS patients. TCRFTA improvements may result from changes in airway volume, apnea index, and respiratory arousal index.

Automatic adjusting nasal continuous positive airway pressure titration (APAP) has been introduced as an alternative method of establishing pressures for patients with sleep apnea. The performance and accuracy of APAP in nonattended home environment are controversial. This study assessed APAP polysomnographic outcomes and accuracy in a nonattended home environment.We conducted a retrospective consecutive case series of 24 consecutive patients who had nonattended APAP and simultaneous full polysomnography (PSG).APAP was tolerated and reduced obstructive Apnea-Hypopnea Index (AHI) to10 events/h in all patients. Mean AHI decreased from 38.4 (21.2) to 5.9 (6.6) events/h. Central apneas worsened in one patient. A therapeutic pressure was determined in 91% of patients. Autoset accurately measured residual AHI compared with PSG (R = 0.77, P0.001). APAP overestimated the AHI by 1.4 events/h.Nonattended APAP is successful in many patients in determining a therapeutic positive pressure setting. Reported AHI via Autoset is similar to that of PSG.APAP reduces AHI and is tolerated in a nonattended environment.

Sleep-disordered breathing is common. In its mildest form, it manifests as snoring which is often considered a cosmetic complaint. Sleep-related breathing disturbances increase in severity to include the upper airway resistance syndrome and obstructive sleep apnea syndrome (OSAS) having established medical morbidity and mortality risks. Overt OSAS affects an estimated 4% of men and 2% of women [1]. Because of its significant social, functional, and medical morbidity, OSAS frequently presents for treatment. Nasal continuous positive airway pressure has been the preferred treatment; however, when this or other conservative treatments fail, surgery may be offered. Surgery may bypass the upper airway obstruction or may reconstruct the upper airway, using either skeletal or soft tissue techniques. It is commonly accepted that airway obstruction in OSA is complex and in most patients multilevel [2]. Surgical goals are to increase airway size, decrease airway collapsibility, decrease airway resistance and the work of breathing, and reduce partial and complete airway obstructions (apnea and hypopnea). Improved ventilation reduces sleep and medical manifestations of OSAS. This article addresses specific surgical procedures to treat lower pharyngeal and tongue-related airway obstruction. Algorithms for treatment Various surgical algorithms have been described to treatbothsnoringandOSAS.Mostdecisionsarebased

In order to obtain relatively simple and useful parameters to estimate the severity of obstructive sleep apnea syndrome (OSAS), cephalometric and fiberoptic studies were performed in 64 clinical cases previously diagnosed with either OSAS or snoring. Fourteen cephalometric parameters, 13 parameters derived from physical examination and 18 fiberoptic parameters were compared with the apnea index (AI), the apnea-hypopnea index and lowest SaO2 values. Statistically significant correlations were found between the Al and the shortest linear distance from the posterior line of the soft palate to the posterior pharyngeal wall measured along a line parallel to the supramentale-Gonion line (PAS-epipharynx distance), the distance from the mandibular plane to the most anterior and superior point on the body of the hyoid bone obtained from cephalometry (MP-H distance) and the degree of redundancy of mucosa in the arytenoid/aryepiglottic fold obtained from videoendoscopy. An increased Al was observed when the PAS-epipharynx distance was7 mm and there was 100% obstruction in Muller's maneuver at the palate level (supine), the MP-H distance was27.4 mm and the mucosa of the arytenoid/aryepiglottic fold was markedly redundant. As these three parameters are relatively easy to obtain on an outpatient basis, it is suggested that they could be used in an outpatient setting to provide a good prediction of the severity of OSAS.

Sleep apnea and sleep-disordered breathing may affect the hypothalamic-pituitary-adrenal axis (HPA) due to hypoxic episodes and sleep disruption [1, 2]. Salivary cortisol is a simple and reliable surrogate for free, biologically active cortisol in the plasma [3]. This study evaluated the effect of continuous positive airway pressure (CPAP) on salivary cortisol as an index of physiologic stress related to sleepiness and obstructive sleep apnea (OSA).

To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures.A randomized controlled therapy withdrawal study.Industry-supported multicenter academic and clinical setting.A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants.Participants were randomized to either therapy maintenance ("ON") group or therapy withdrawal ("OFF") group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed.Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months.Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.

Objectives:(1) Determine the influence of drug-induced sleep endoscopy (DISE) on the surgical decision for upper airway stimulation (UAS) therapy. (2) Learn the limitations of drug induced sleep endoscopy.Methods:This was a single-blinded cross-sectional study in which 4 surgeons with extensive experience with DISE reviewed blinded DISE video clips from 63 patients who were screened for participation in the STAR (Stimulation Therapy for Apnea Reduction) trial, a phase III trial of upper airway stimulation (UAS) of the hypoglossal nerve for moderate-to-severe sleep apnea (OSA). Each DISE clip was independently reviewed and graded by a surgeon who then predicted whether the patient was a candidate for UAS therapy.Results:Evaluators demonstrated a high level of 100% agreement with regard to the presence of palatal collapse in 81% of cases, but less complete agreement concerning hypopharyngeal collapse (64% of cases). The viewers had complete agreement with regards to the presence or absence of circumferentia...