Study Design Considerations for Sleep Disordered Breathing Devices
Mann EA, Nandkumar S, Addy N, Demko BG, Freedman NS, Gillespie MB, Headapohl W, Kirsch DB, Phillips BA, Rosen IM, Schneider LD, Stepnowsky CJ, Yaremchuk KL, and Eydelman MB. Study Design Considerations for Sleep Disordered Breathing Devices. J Clin Sleep Med 2020.
J Clin Sleep Med
None: 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 Food and Drug Administration (FDA) 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.
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