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Feng-Hsiang Chiu,1,2 Yi Chang,3 Wen-Wei Liao,3 Yu-Ling Yeh,3 Chia-Mo Lin,4– 6 Ofer Jacobowitz,7 Ying-Shuo Hsu8,9 1Department of Otolaryngology, Head and Neck Surgery, Tri-service General Hospital, Taipei, Taiwan; 2National Defense Medical Center, Taipei City, Taiwan; 3Department of Anesthesiology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; 4Division of Chest Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; 5Department of Chemistry, Fu-Jen Catholic University, New Taipei City, Taiwan; 6Graduate Institute of Biomedical and Pharmaceutical Science, Fu Jen Catholic University, New Taipei City, Taiwan; 7ENT & Allergy Associates, New York, NY, USA; 8Department of Otolaryngology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; 9School of Medicine, Fu Jen Catholic University, New Taipei City, TaiwanCorrespondence: Ofer JacobowitzENT & Allergy Associates, New York, NY, USATel +1 646 868-4300Email ojacobowitz@entandallergy.comYing-Shuo HsuDepartment of Otolaryngology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, TaiwanTel +1-886-2-28332211 ext.2551Email sulisky@gmail.comIntroduction: 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.Keywords: obstructive sleep apnea, drug-induced sleep endoscopy, palatopharyngoplasty, postoperative, complete concentric collapse, tongue base collapse

Kuo YH, Liu TJ, Chiu FH, et al. Nat Sci Sleep. 2021;13:2087–2099. The authors have advised that the funding statement on page 2098 is incorrect. The text “This study was supported by a grant from Shin Kong Wu- Ho-Su memorial Hospital (2018SKHADR018)” should read “This study was supported by a grant from Shin Kong Wu-Ho-Su memorial Hospital (2019SKHADR027)”. The authors apologize for this error. Read the original article

Objective: Obstructive sleep apnea (OSA) is a prevalent disorder, with oral breathing influencing its severity. Expiratory velopharyngeal obstruction (EVO), observed during drug-induced sleep endoscopy (DISE), may contribute to oral breathing in OSA patients. EVO results in obstruction between the pharynx and nasal cavity during expiration. This study aims to identify factors associated with positive EVO during DISE., Study Design: Case series., Setting: Tertiary Medical Center., Methods: Seventy-two OSA patients underwent clinical evaluation, polysomnography, and DISE, utilizing interventions like intraoral negative airway pressure (iNAP), mouth closure, and oral appliances (OAs) in supine positions with head rotation. The findings, classified under velopharynx, oropharynx, tongue base, epiglottis, included the presence of EVO., Results: The results demonstrated that interventions including mouth closure and iNAP were associated with increased observation of EVO (43.1% and 34.7%) compared to OA (20.1%). However, head rotation was associated with decreased presence of EVO during DISE compare to supine (26% vs 35.8%). Noticeably, per 1 year increase of age was associated with an increased odds of EVO (odds ratio: 1.03, 95% confidence interval: 1.01-1.06). However, no other baseline characteristics were significantly associated the odds of EVO., Conclusion: Our study reveals the effectiveness of head rotation and OA in reducing EVO and improving mouth breathing in OSA patients, offering valuable insights for future treatment strategies., (© 2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.)

Purpose: Learning how to use barbed sutures and perform Barbed Pharyngoplasty (BP) is challenging due to limited surgical training opportunities. This work aims to design, develop, and validate a new 3D surgical simulator to train ENT residents and specialists in performing BP., Methods: The Barbed Pharyngoplasty Simulator (BPS) was designed using diagnostic images of the facial mass and testing different materials to replicate the mucosal and bony tissues. ENT specialists with experience in BP and ENT residents were included in the validation study and were asked to perform the Alianza BP. After the simulation, they compiled the Face and Content Validity Questionnaires., Results: The BPS consists of a reusable cranial structure that contains the disposable palatopharyngeal structure, replicating the palatal structures and the tongue. Fifteen experienced ENT specialists and nine residents were included in the study. Findings demonstrated that the BPS faithfully replicated the muscular and fibrous-bony palatopharyngeal structures, with only 11% of residents having a negative opinion of the mucosal tissue. All the participants positively rated the sensation of using surgical instruments on the simulator. Also, ENT residents rated all aspects of the content validity test from normal to excellent, while specialists rated the BPS as a general training tool from normal to excellent; for lateral pharyngoplasty, BP, and Alianza, only 6.7% of participants disagreed with its usefulness, and 13.3% disagreed with it for anterior pharyngoplasty., Conclusion: The BPS proposed in this preliminary study can potentially be a valuable tool in BP surgical training for residents and young otolaryngologists., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Upper airway (UA) surgery is commonly employed in the treatment of patients with obstructive sleep apnea (OSA). The intricate pathophysiology of OSA, variability in sites and patterns of UA collapse, and the interaction between anatomical and non-anatomical factors in individual patients may contribute to possible surgical failures. This clinical consensus statement aims to identify areas of agreement among a development group comprising international experts in OSA surgery, regarding the appropriate definition, predictive factors in patients, and management of surgical failure in OSA treatment., Methods: A clinical consensus statement (CCS) was developed using the Delphi method by a panel of 35 contributors from various countries. A systematic literature review adhering to PRISMA guidelines was conducted. A survey consisting of 60 statements was then formulated and presented to the experts., Results: Following two rounds of the Delphi process, consensus or strong consensus was achieved on 36 items, while 24 items remained without consensus. Specifically, 5 out of 10 statements reached consensus regarding on the 'Definition of Surgical Success/Failure after OSA Surgery'. Regarding the 'Predictive Factors of Surgical Failure in OSA Surgery', consensus was reached on 10 out of 13 statements. In the context of the 'Diagnostic Workup in OSA Surgery', consensus was achieved on 9 out of 13 statements. Lastly, in 'Treatment in Surgical Failure Cases', consensus was reached on 12 out of 24 statements., Conclusion: The management of OSA after surgical failure presents a significant clinical challenge for sleep specialists. This CCS provides valuable guidance for defining, preventing, and addressing surgical failures in the treatment of OSA syndrome., Competing Interests: Declarations Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study.My manuscript has no associated data. Conflict of interest All authors declare no conflicts of interest and no competing interests., (© 2024. The Author(s).)

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., (© 2023 American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

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., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ofer Jacobowitz reports a relationship with LivaNova USA, Inc. That includes: consulting or advisory. Ofer Jacobowitz reports a relationship with Nyxoah SA that includes: consulting or advisory. Clete Kushida reports a relationship with Vivos Therapeutics that includes: consulting or advisory., (Copyright © 2023. Published by Elsevier B.V.)

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/m 2 , 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., (© 2023 American Academy of Otolaryngology-Head and Neck Surgery Foundation.)

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., (© 2023. The Author(s).)

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.

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., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Elsevier B.V. All rights reserved.)

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., (© 2020. Springer Nature Switzerland AG.)

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., (© 2021 American Academy of Sleep Medicine.)

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., Competing Interests: Ofer Jacobowitz reports grants and personal fees from Livanova and personal fees from Nyxoah Medical, outside the submitted work. The authors report no other potential conflicts of interest for this work., (© 2021 Kuo et al.)

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., (© 2020 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.)

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., (© 2020 American Academy of Sleep Medicine.)

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

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.

Study Objectives: Although drug-induced sleep endoscopy (DISE) is an accepted method to localize upper airway obstruction, it is not known whether all sites identified by DISE must be treated to achieve sufficient apnea-hypopnea index (AHI) improvement. The aim of this study was to compare outcomes for unilevel (upper) versus multilevel DISE collapse patterns in a patient cohort that only underwent modern palatopharyngoplasty. Our hypothesis was that not all tongue base-level obstructions on DISE must be treated., Methods: Thirty-eight patients with mean AHI of 45 events/h underwent DISE followed by palatopharyngoplasty. Outcome was measured by polysomnography or home sleep apnea testing., Results: Eleven patients (29%) had multilevel, complete tongue base obstruction and nineteen (50%) had no obstruction. These two groups were similar in age, body mass index, and AHI; the complete group had smaller tonsils and higher tongue position. The postoperative success rate and AHI in the group without tongue base obstruction were not significantly different from those of the complete group (68%; 17.4 ± 11.0 versus 73%; 15.4 ± 20.5, P > .99). Seventeen patients (45%) had circumferential collapse of velum. The postoperative AHI was higher for patients with circumferential collapse (23.6 ± 15.8 from 55.3 ± 22.1 versus 10.5 ± 9.94 from 36.4 ± 16.7, P < .0001), but both groups had clinically and statistically significant AHI reductions., Conclusions: Patients with multilevel obstruction on DISE, treated with palatopharyngoplasty alone, had similar AHI outcome as those with unilevel obstruction. Multilevel surgery may not be needed in some patients with a multilevel obstruction pattern. Circumferential collapse of velum, however, was associated with a higher residual AHI., (© 2017 American Academy of Sleep Medicine)

Oral appliances that advance the mandible are widely used as alternatives to positive airway pressure (PAP) devices or as primary therapy for obstructive sleep apnea (OSA) in adults. Although PAP is more efficacious at lowering the polysomnographic indices of OSA, the clinical effectiveness of PAP and oral appliances is similar, and patients are more likely to adhere to oral appliance therapy than to PAP treatment. Clinical examination is used to determine the candidacy of oral appliances and to select a particular appliance for a given patient. Endoscopic examination of the pharynx may be used to help assess the potential for efficacy. Otherwise, if available, titration of mandibular protrusion during sleep may be performed prior to appliance production in order to assess efficacy. Once a patient is fitted with a titratable oral appliance, further advancement is usually performed at home to resolve the clinical symptoms and signs of OSA. Clinical follow-up is needed to assess the outcome, side effects, and adherence, as the long-term adherence rate is approximately 50%. Recent advances in oral appliance therapy include the development of embedded temperature sensors for adherence monitoring and the production of thinner, lighter appliances via 3D printing techniques., (© 2017 S. Karger AG, Basel.)

Objectives/hypothesis: This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy., Study Design: Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe., Methods: Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy., Results: Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO 2 decrease > 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients., Conclusions: This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients., Level of Evidence: 2b Laryngoscope, 126:2618-2623, 2016., (© 2016 The American Laryngological, Rhinological and Otological Society, Inc.)

Abstract: Obstructive sleep apnea (OSA) is a prevalent disorder associated with a multitude of adverse outcomes when left untreated. There is significant heterogeneity in the evaluation and management of OSA resulting in variation in cost and outcomes. Thus, the goal for developing these measures was to have a way to evaluate the outcomes and reliability of the processes involved with the standard care approaches used in the diagnosis and management of OSA. The OSA quality care measures presented here focus on both outcomes and processes. The AASM commissioned the Adult OSA Quality Measures Workgroup to develop quality care measures aimed at optimizing care for adult patients with OSA. These quality care measures developed by the Adult OSA Quality Measures Workgroup are an extension of the original Centers for Medicare & Medicaid Services (CMS) approved Physician Quality Reporting System (PQRS) measures group for OSA. The measures are based on the available scientific evidence, focus on public safety, and strive to improve quality of life and cardiovascular outcomes for individual OSA patients. The three outcomes that were selected were as follows: (1) improve disease detection and categorization; (2) improve quality of life; and (3) reduce cardiovascular risk. After selecting these relevant outcomes, a total of ten process measures were chosen that could be applied and assessed for the purpose of accomplishing these outcomes. In the future, the measures described in this document may be reported through the PQRS in addition to, or as a replacement for, the current OSA measures group. The overall objective for the development of these measures is that implementation of these quality measures will result in improved patient outcomes, reduce the public health burden of OSA, and provide a measurable standard for evaluating and managing OSA., (© 2015 American Academy of Sleep Medicine.)

Introduction:  Obstructive sleep apnea (OSA) is a chronic condition that affects millions adults. The effective standard treatment is positive airway pressure (PAP). However, approximately half of the patients that are prescribed PAP are unable or unwilling to comply with this therapy. Untreated OSA ultimately leads to very serious comorbidities. An alternative therapy for this patient population, therefore, is desirable. Hypoglossal nerve (HGN) stimulation is under investigation by multiple groups as a possible alternative therapy for OSA., Objective: To understand the underlying mechanisms of actions related to HGN stimulation, and the implication of this knowledge for specifying and designing a neurostimulation system for the treatment of OSA., Results:  Loss of lingual and pharyngeal tone within a narrow airway is the primary mechanism for OSA. Posterior and anterior tongues are different in their anatomy and physiology. Muscle fibers in the posterior tongue are predominantly fatigue resistant that are responsible for the long sustained tonic activities required for maintaining the tongue's position and preventing its mass from falling into the retroglossal airway. The human tongue is a muscular hydrostat and hence would benefit from a sophisticated HGN stimulation system that is capable of achieving a concerted spatio-temporal interplay of multiple lingual muscles, including retrusors., Conclusion:  Targeted neurostimulation of the proximal HGN presents as a viable system approach that is far more versatile and physiologic and quite different than prior systems., (© 2012 International Neuromodulation Society.)

Positive airway pressure can be effective for OSA treatment but is not effectively used by many patients. Surgical reconstruction of the airway is appropriate for patients who are not otherwise effectively treated or as first-line treatment for patients with focal airway lesions. For surgical planning, examination schemes of the awake patient, as well as sleep endoscopy may be used. Nasal surgery may facilitate treatment using positive airway pressure or oral appliances or to improve quality of life. Pharyngoplasty and tongue base techniques for therapeutic upper airway reconstruction may be performed staged or simultaneously. Current and future approaches are described., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: To assess the effect of concurrent uvulopalatopharyngoplasty (UPPP) and hypopharyngeal procedures in obstructive sleep apnea (OSA) patients with diffuse airway narrowing., Study Design and Setting: Forty-eight patients were treated surgically by a single surgeon in private practice over 2 years. Symptoms, Epworth score, and polysomnographic outcome were assessed preoperatively and postoperatively. The Friedman staging system was applied. UPPP with genioglossus advancement, hyoid suspension, or radiofrequency treatment was carried out., Results: In 37 patients with complete data, the average apnea-hypopnea index (AHI) was reduced from 46.5 +/- 24.8 to 14.9 +/- 16.8. The Epworth score was reduced from 12.1 +/- 4.9 to 6.7 +/- 3.7. Most patients reported improved sleep quality, alertness, memory, concentration, and mood., Conclusion: Successful outcome, defined by symptom and AHI reduction, was achieved with multilevel surgery for most patients with advanced Friedman stages 2 and 3., Significance: Multilevel surgery seems effective in treating severe OSA patients with diffuse airway narrowing., Ebm Rating: C-4.

Objective: To demonstrate a causal relationship between bone dust and the development of headache after retrosigmoid removal of acoustic neuromas., Study Design: The study design was both retrospective (group I) and prospective (groups 2 and 3)., Setting: Tertiary Care Referral Center/Outpatient Data Collection., Patients: Eighty-four consecutive patients underwent surgery at the Mount Sinai Medical Center in New York by the same surgical team., Intervention: All patients underwent retrosigmoid removal of acoustic neuromas via the following methods: group 1, standard excision; group 2, excision and cranioplasty; group 3, excision, cranioplasty, and residue trapping., Main Outcome Measure: Presence or absence of postoperative headache., Results: In all, 43 patients (51%) reported postoperative headache. By groups, headache incidence was 64% for group 1 (43% grade 3-4), 81% for group 2 (37% grade 3-4), and 10% (all grade 1) for group 3. Differences with respect to headache incidence and severity were statically significant between groups 1 and 3, and between groups 2 and 3 (p < 0.001)., Conclusions: Free circulation of bone dust into the posterior fossa during intradural drilling of the internal auditory canal may be the most important factor in the development of headache after this surgical procedure.