Endorsement of "European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea" by World Sleep Society.

Guidelines for management of sleep disorders from national or regional societies provide recommendations that may be regionally appropriate but may not always be practical or relevant in other parts of the world. A task force of experts from the World Sleep Society's (WSS) International Sleep Medicine Guidelines Committee and Sleep and Breathing Disorders Task Force reviewed the European Respiratory Society's guideline on non-CPAP therapies for obstructive sleep apnea (OSA) with respect to its relevance and applicability to the practice of sleep medicine by sleep specialists in various regions of the world. The task force and the WSS guidelines committee endorsed the European Respiratory Society's guideline with respect to the utilization of bariatric surgery, mandibular advancement devices, positioning devices, myofunctional therapy, hypoglossal neurostimulation, maxilo-mandibular surgery, and carbonic anhydrase inhibitors for the treatment of OSA. The task force and the WSS guidelines committee noted that there is substantial new evidence for the role of soft tissue, upper airway surgery, not included in the guidelines paper.

Potential Treatments for Epiglottic Collapse in Obstructive Sleep Apnea: How Modified Drug-Induced Sleep Endoscopy Help?

OBJECTIVE: In patients with obstructive sleep apnea (OSA), epiglottic collapse (EC) constitutes a major factor in the failure of continuous positive airway pressure therapy and uvulopalatopharyngoplasty. This study explored treatments that can improve EC in patients with OSA through drug-induced sleep endoscopy with target-controlled infusion (TCI-DISE). STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary center. METHODS: This study screened 352 OSA patients who underwent TCI-DISE between 2016 and 2022. Fifty-four patients with EC were included in the final analysis. EC severity was assessed multiple times through TCI-DISE with different interventions. RESULTS: The application of these interventions in patients with anteroposterior epiglottic collapse (apEC) led to a significant decrease in apEC severity from total to partial or no obstruction in 60.0% of patients by head rotation, in 53.6% by mouth closure, in 47.4% who received oral appliances (OA), and in 28.0% who received intermittent negative airway pressure (iNAP). With simultaneous head rotation, apEC severity decreased more significantly from total to partial or no obstruction in 77.8% of patients by mouth closure, in 70.3% who received OA, and in 68.0% who received iNAP. Lateral epiglottic collapse (latEC) severity decreased in 53.8% of patients after OA use and in 61.5% of patients with OA use and head rotation. CONCLUSION: This study identified head rotation with mouth closure as the most effective treatment for apEC through TCI-DISE. Patients with latEC had higher weight, apnea-hypopnea index, and body mass index compared with patients with apEC. OA use with head rotation appeared more effective in latEC through TCI-DISE.

Could the use of a new novel bipolar radiofrequency device (Aerin) improve nasal valve collapse? A systematic review and meta-analysis.

BACKGROUND: Surgical treatment for nasal obstruction caused by nasal valve collapse requires a significant recovery period and risks of complications, while nasal dilators are uncomfortable. Recently, radiofrequency treatment of lateral walls has been used under local anesthesia as an office base surgery. This work aims to assess the efficacy of a new radiofrequency device, the Vivaer™ System (Aerin Medical, Sunnyvale, CA), to treat nasal obstruction through a systematic review and meta-analysis. METHODS: Two researchers independently reviewed the literature up to December 2021. Studies on patients seeking treatment for nasal obstruction due to nasal valve collapse were included in the analysis. RESULTS: Four studies (218 patients) met the inclusion criteria and treated the nasal valve regions bilaterally with the Aerin Medical Vivaer™ System. After the treatment, the NOSE score was reduced at three months postoperatively. Minor adverse events were reported in the included studies, and two showed no complications. None of the studies reported changes in the external appearance of the nose. CONCLUSION: The radiofrequency treatment using the Vivaer device can be useful for treating nasal valve collapse, improving significantly subjective breathing symptom scores. Further studies on a large scale are needed to confirm these results.

Upper Airway Surgery or Weight Control? Modified Drug-Induced Sleep Endoscopy for Obstructive Sleep Apnea.

OBJECTIVE: To identify the value of head rotation in the supine position and oral appliance (OA) use in drug-induced sleep endoscopy (DISE). STUDY DESIGN: Eighty-three sleep apnea adults undergoing target-controlled infusion-DISE (TCI-DISE) were recruited from a tertiary academic medical center. SETTING: During DISE, 4 positions were utilized: supine position (position 1), head rotation (position 2), mandibular advancement using an OA (position 3), and head rotation with an OA (position 4). METHODS: Polysomnography (PSG) data and anthropometric variables during DISE were analyzed. RESULTS: Eighty-three patients (65 men and 18 women; mean [standard deviation, SD], 48.5 [11.0] years) who underwent PSG and TCI-DISE were included. The mean (SD) apnea-hypopnea index (AHI) was 35.5 (22.4) events/h. Twenty-three patients had persistent complete concentric velopharyngeal collapse in the supine position, even with concurrent head rotation and OA (position 4). Their mean (SD) AHI was 54.7 (24.6) events/h, significantly higher than that of the 60 patients without such collapse in position 4 (p < .001). Their mean (SD) body mass index (BMI) was 29.0 (4.1) kg/m2 , also significantly higher (p = .005). After adjustment for age, BMI, tonsil size, and tongue position, the degree of velum and tongue base obstruction was significantly associated with sleep apnea severity in positions 2, 3, and 4. CONCLUSION: We showed the feasibility, safety, and usefulness of using simple edge-to-edge, reusable OA in DISE. Patients who are not responsive to head rotation and OA during TCI-DISE may need upper airway surgery and/or weight control.

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA). Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA. Design, Setting, and Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023. Intervention: Implant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively. Main Outcomes and Measures: Primary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale). Results: Among 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol. Conclusions and Relevance: This randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI. Trial Registration: ClinicalTrials.gov Identifier: NCT02263859.

Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial.

Obstructive sleep apnea (OSA) affects nearly 1 billion people worldwide, including approximately 35 million US residents. OSA has detrimental cardiovascular and neurocognitive consequences. Positive airway pressure corrects sleep disordered breathing but is not always tolerated or used sufficiently. Oral appliances and surgery provide alternatives in select populations but are variably effective. Hypoglossal nerve stimulation can effectively treat obstructive sleep apnea. Targeted hypoglossal nerve stimulation (THN) is simpler than incumbent technology with no sensor and an easier, proximal electrode implantation. The third clinical study of THN, THN3, was the first randomized, controlled trial of hypoglossal nerve stimulation to demonstrate significant improvement of sleep disordered breathing in OSA. The present investigation reports the design of a novel trial of targeted stimulation to provide additional Level 1 evidence in moderate to severe obstructive apnea. OSPREY is a randomized, parallel-arm, 13-month trial wherein all subjects are implanted, 2/3 are activated at Month 1 ("Treatment") and 1/3 are activated at Month 7 ("Control"). The primary endpoint is the difference in apnea-hypopnea index response rates between Treatment and Control groups at Month 7. Secondary endpoints include quality of life and oximetry metrics. OSPREY follows an adaptive "Goldilocks" design which optimizes the number of subjects with the need for high-confidence results. A maximum of 150 subjects is allowed, at which study power of >95% is predicted. Interim analyses begin once 50 patients are randomized and recur after each 20 additional randomizations to detect early success or futility. OSPREY is a unique, efficient trial that should provide high-confidence confirmation of the safety and efficacy of targeted hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea.

Endorsement of: "treatment of adult obstructive sleep apnea with positive airway pressure: an American academy of Sleep Medicine Clinical Practice Guideline" by World Sleep Society.

Guidelines for the evaluation and management of sleep disorders from national societies provide recommendations that may be regionally appropriate but may not always be practical or relevant in other parts of the world. A task force of experts from the World Sleep Society's (WSS) International Sleep Medicine Guidelines Committee and Sleep and Breathing Disorders Taskforce reviewed the American Academy of Sleep Medicine's Clinical Practice Guideline on the Treatment of Adult Obstructive Sleep Apnea (OSA) with Positive Airway Pressure with respect to its relevance and applicability to the practice of sleep medicine by sleep specialists in various regions of the world. To improve the evaluation of the guideline, surveys were sent by the senior author and the WSS to approximately 800 sleep doctors around the world to query the availability of OSA treatments in their respective region. The task force and the WSS guidelines committee endorsed the AASM's CPAP guidelines with respect to the indications for PAP therapy, utilization of different PAP modalities, and concurrent strategies to improve outcomes, noting appropriate caveats for universal applicability.

Novel Intraoral Negative Airway Pressure in Drug-Induced Sleep Endoscopy with Target-Controlled Infusion.

BACKGROUND: In intermittent negative airway pressure (iNAP) therapy, soft tissues are reshaped into a forward-resting position, thus reducing airway obstruction during sleep. This study investigated the effect of iNAP therapy that was administered during drug-induced sleep endoscopy with target-controlled infusion (TCI-DISE) in patients with obstructive sleep apnea (OSA) intolerant of continuous positive airway pressure (CPAP) therapy. METHODS: This prospective case series study included 92 patients with polysomnography (PSG)-confirmed OSA who underwent TCI-DISE with iNAP from January 2018 to February 2020 at a tertiary referral hospital. Upper airway obstruction was evaluated and scored using the velum, oropharynx, tongue base, and epiglottis (VOTE) classification. Obstruction severity was assessed multiple times with the patient in the supine position with or without lateral rotation of the head and the application of iNAP therapy, respectively. RESULTS: After the application of iNAP therapy in the supine position, obstruction severity decreased significantly: from complete or partial obstruction to partial or no obstruction in 37, 12, and 36 patients (40.2%, 13%, and 39%, respectively) with velar obstruction, oropharyngeal, and tongue base obstruction, respectively. After simultaneously applying iNAP therapy with head rotation, obstruction severity decreased in 47, 43, and 19 patients (51%, 47%, and 21%, respectively) with velar, tongue base, and epiglottic obstruction, respectively. CONCLUSION: In TCI-DISE, we found that iNAP therapy relieved velar, oropharyngeal, and tongue base obstruction in the supine position in some patients. Moreover, iNAP therapy can be combined with positional therapy to alleviate velar, tongue base, and epiglottic obstruction in some patients. TCI-DISE can also be used to screen the possible responders for iNAP therapy because it is less time consuming than PSG.

Post-Operative Sleep Endoscopy with Target-Controlled Infusion After Palatopharyngoplasty for Obstructive Sleep Apnea: Anatomical and Polysomnographic Outcomes.

INTRODUCTION: The findings of drug-induced sleep endoscopy (DISE) are not always correlated with the outcome of upper airway surgery for obstructive sleep apnea (OSA), and whether multilevel surgery is truly required in treating multilevel obstruction identified in preoperative DISE remains an issue. We attempted to compare DISE findings before and after palatopharyngoplasty in patients with OSA because changes in DISE may be beneficial to better understand polysomnographic and anatomical outcomes. METHODS: This was a prospective cohort study for 34 patients with moderate to severe OSA who underwent palatopharyngoplasty at a tertiary care center from 2016 to 2018. We recorded the patients' demographic characteristics, procedures, and surgical outcomes and compared the preoperative and postoperative DISE staging patterns. RESULTS: The apnea-hypopnea index (AHI) values of 34 adults improved significantly after surgery (40.6 ± 23.3 versus 25.6 ± 20.6, P < 0.001). The majority of patients, 26/34, had preoperative complete concentric collapse at the velum, and for most (20/26, 77%) there was a change of the collapse pattern into anteroposterior collapse postoperatively. Patients with postoperative velar collapse had higher follow-up AHI values than those who without (27.8 ± 21.9 versus 15.2 ± 7.7, P = 0.023). Patients with preoperative complete tongue base collapse had higher follow-up AHI values than did those with no or partial collapse (40.6 ± 21.0 versus 21.0 ± 18.6, P = 0.017). Patients with postoperative complete tongue base collapse also had higher follow-up AHI values than the others (42.7 ± 22.1 versus 18.5 ± 15.4, P = 0.001). CONCLUSION: Palatopharyngoplasty could change the collapse pattern at the velum in most patients. Preoperative and postoperative complete tongue base collapse and postoperative velar collapse identified in TCI-DISE were associated with relatively poor outcomes.

Improving outcomes of hypoglossal nerve stimulation therapy: current practice, future directions, and research gaps. Proceedings of the 2019 International Sleep Surgery Society Research Forum.

Hypoglossal nerve stimulation (HGNS) has evolved as a novel and effective therapy for patients with moderate-to-severe obstructive sleep apnea. Despite positive published outcomes of HGNS, there exist uncertainties regarding proper patient selection, surgical technique, and the reporting of outcomes and individual factors that impact therapy effectiveness. According to current guidelines, this therapy is indicated for select patients, and recommendations are based on the Stimulation Therapy for Apnea Reduction or STAR trial. Ongoing research and physician experiences continuously improve methods to optimize the therapy. An understanding of the way in which airway anatomy, obstructive sleep apnea phenotypes, individual health status, psychological conditions, and comorbid sleep disorders influence the effectiveness of HGNS is essential to improve outcomes and expand therapy indications. This article presents discussions on current evidence, future directions, and research gaps for HGNS therapy from the 10th International Surgical Sleep Society expert research panel. CITATION: Suurna MV, Jacobowitz O, Chang J, et al. Improving outcomes of hypoglossal nerve stimulation therapy: current practice, future directions and research gaps. Proceedings of the 2019 International Sleep Surgery Society Research Forum. J Clin Sleep Med. 2021;17(12):2477-2487.

Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial.

BACKGROUND: Insufficiency of the nasal valve is increasingly being recognized as a cause of nasal airway obstruction. The condition is associated with many symptoms, including nasal congestion, sleep disturbance, snoring, and an overall decline in quality of life (QoL). An in-office, minimally invasive radiofrequency treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QoL for a 6-month period in a noncontrolled, prospective, single-arm study. The purpose of this study was to determine whether the results achieved with radiofrequency treatment at 6 months would be sustained through 24 months. METHODS: Thirty-nine adult patients from an original cohort of 49 patients with severe to extreme Nasal Obstruction Symptom Evaluation (NOSE) Scale scores and dynamic or static internal nasal valve obstruction as the primary or significant contributor to obstruction were studied. Patients received intranasal bilateral radiofrequency treatment in a clinical study with a follow-up to 6 months, and were prospectively evaluated at 12, 18, and 24 months at 8 community-based otolaryngology practices. The patient-reported NOSE Scale score and 21 QoL questions were assessed. RESULTS: Clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean, 55.9; standard deviation [SD], 23.6; p < 0.0001) was maintained through 24 months (mean, 53.5; SD, 24.6; p < 0.0001). Responders (≥15-point improvement) consisted of 92.3% of participants at 6 months and 97.2% at 24 months. Responses to the QoL questions also showed improvement in patients' QoL. CONCLUSION: Treatment of the nasal valve with an in-office, transnasal temperature-controlled radiofrequency procedure was associated with stable and lasting improvement in symptoms of nasal obstruction and QoL through 24 months in this noncontrolled, single-arm study.

Sleep medicine in otolaryngology units: an international survey.

PURPOSE: No study to date has described the overall landscape of sleep disorders management and training in otolaryngology departments of different countries. The aim of our study was to investigate and compare settings, diagnostic and therapeutic approaches and training programmes. METHODS: An international online survey was developed with the collaboration of the YO-IFOS (Young Otolaryngologists-International Federation of Otorhinolaryngological Societies) to assess the current practice of otolaryngologists in the management of sleep disorders. The survey also included a session dedicated to training. RESULTS: A total of 126 otolaryngologists completed the survey. The larger part of responses was collected from Central/South America and Europe. The majority of responders from South/Central America (97%) declared to be certified as sleep specialist while 49% of Europeans stated the opposite. Of responders 83% perform a drug-induced sleep endoscopy (DISE) before planning a possible surgical intervention. Soft palate and base of tongue interventions were the most common procedure, respectively performed in 94% and 79% of the cases. Residents were allowed to perform soft palate surgery in 77% of the cases. Upper airway stimulation (26% vs 10%), trans-oral robotic surgery (36% vs 11%) and radiofrequency of the base of the tongue (58% vs 25%) were preferred more frequently by European responders. The highest caseloads of soft palate surgery and bi-maxillary advancement were registered in the academic institutions. CONCLUSION: Significant concordance and few interesting divergences in diagnosis and treatment of sleep disorders were observed between nationalities and types of institution. Economic resources might have played a significant role in the therapeutic choice. Trainees' lack of exposure to certain interventions and to a sufficient caseload appeared to be the main burden to overcome.

Addressing gaps between payer policies and AASM clinical practice guidelines using scorecards.

None: The Payer Policy Review Committee of the American Academy of Sleep Medicine launched an initiative to assess the alignment between clinical practice guidelines and private payer medical policies. This article summarizes the importance of the initiative, details the scorecard development process, including an analysis of policy scores and subsequent revisions, and discusses the impact of the scorecards particularly as related to the scorecards on the clinical practice guideline for diagnosis of obstructive sleep apnea in adults. This initiative has increased communication and engagement among members of the Payer Policy Review Committee and private payers, creating opportunities to advocate on behalf of sleep medicine providers and patients with sleep disorders, encouraging payers to modify existing policies so that evidence-based care is provided to patients with sleep disorders.

A New Metric for Precision Medicine: PAP and Hypoglossal Neurostimulation.

CITATION: Jacobowitz O, Woodson BT. A new metric for precision medicine: PAP and hypoglossal neurostimulation. J Clin Sleep Med. 2019;15(8):1079-1080.

In-office treatment of nasal valve obstruction using a novel, bipolar radiofrequency device.

OBJECTIVES: To assess the safety and effectiveness of in-office bipolar radiofrequency treatment of nasal valve obstruction. STUDY DESIGN: Prospective, nonrandomized, multicenter case series. METHODS: Adult patients with a Nasal Obstruction Symptom Evaluation scale (NOSE) score ≥60 were selected. Patients were clinically diagnosed with dynamic or static internal nasal valve obstruction as primary or significant contributor to obstruction and were required to have a positive response to nasal mechanical dilators or lateralization maneuvers. Bilateral radio-frequency treatment was applied intranasally using a novel device, under local anesthesia in a single session. Safety and tolerance were assessed by event reporting, inspection, and Visual Analogue Scale (VAS) for pain. Efficacy was determined using the NOSE score and patient-reported satisfaction survey at 26 weeks. RESULTS: Fifty patients were treated. No device or procedure-related serious adverse events occurred. Soreness, edema, and crusting resolved by 1 month. The mean baseline NOSE score was 79.9 (SD 10.8, range 60-100), and all had severe or extreme obstruction. At 26 weeks, mean NOSE score was 69% lower at 24.7 (P < .0001) with 95% two-sided confidence intervals 48.5 to 61.1 for decrease. The decrease in NOSE score did not differ significantly between patients who did or did not have prior nasal surgery. Patient satisfaction mean by survey was 8.2 of 10. CONCLUSION: In office treatment of internal nasal valve obstruction using a bipolar radiofrequency device is safe and well-tolerated. Nasal obstruction, as assessed using the NOSE questionnaire at 26 weeks, was markedly improved with high patient satisfaction. LEVEL OF EVIDENCE: 2b, prospective cohort.

Drug-Induced Sleep Endoscopy and Surgical Outcomes: A Multicenter Cohort Study.

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.