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In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel’s breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices. CITATION: Mann EA, Nandkumar S, Addy N, et al. Study design considerations for sleep-disordered breathing devices. J Clin Sleep Med. 2020;16(3):441–449.

To determine the incidence, duration, and predictors of swallowing-related symptoms following upper airway surgery for obstructive sleep apnea.Adults (age 18 years or older) who underwent surgery for obstructive sleep apnea at a tertiary care institution from January 2012 to December 2015 were retrospectively reviewed. The incidence, duration, and associated factors of postoperative swallowing complaints were evaluated.A total of 130 patients (135 surgical encounters) met criteria for inclusion. There were 91 men (70.0%) and 39 women (30.0%) with a median age of 60 years (range: 19-79). Presurgical diagnosis of gastroesophageal reflux disease was present in 57 patients (43.8%). An average of 2.1 procedures (± 0.8) were conducted at each encounter. Uvulopalatopharyngoplasty (54.8%) was the most common followed by radiofrequency ablation of the soft palate (34.8%) and tongue base (29.6%). Postoperatively, 25 patients (19.8%) complained of dysphagia, 14 (10.9%) of globus, and 9 (6.7%) of odynophagia. Preoperative gastroesophageal reflux (odds ratio [OR] 4.09, 95% confidence interval [CI] 1.41-11.91) and hyoid myotomy with suspension (OR 4.88, 95% CI 1.34-17.77) were significant predictors for dysphagia. Radiofrequency ablation of the tongue base (OR 5.00, 95% CI 1.28-19.50) was a predictor for globus sensation. Median symptom durations, in months, were 4.0 for dysphagia, 7.3 for globus, and 3.0 for odynophagia.Preoperative gastroesophageal reflux and hyoid myotomy with suspension procedure were associated with postoperative dysphagia whereas radiofrequency ablation of the tongue base was associated with globus. These findings can assist surgeons in providing preoperative counseling and postoperative supportive measures regarding dysphagic symptoms following sleep surgery.