Mann Eric A, Nandkumar Srinivas, Addy Nancy, Demko B Gail, Freedman Neil S, Gillespie M Boyd, Headapohl William, Kirsch Douglas B, Phillips Barbara A, Rosen Ilene M, Schneider Logan D, Stepnowsky Carl J, Yaremchuk Kathleen L, Eydelman Malvina B
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
American Academy of Dental Sleep Medicine, Lisle, Illinois.
J Clin Sleep Med. 2020 Mar 15;16(3):441-449. doi: 10.5664/jcsm.8226. Epub 2020 Jan 14.
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.
近年来，睡眠呼吸紊乱（SDB）已被公认为成年人中一种普遍但诊断不足的病症，这促使人们需要新的、更好的诊断和治疗选择。为了促进为美国患者开发创新、安全且有效的SDB医疗设备技术并使其可供使用，美国食品药品监督管理局与六个与SDB相关的专业协会以及一个消费者权益倡导组织合作，召开了一次以SDB设备临床研究为重点的公开研讨会。睡眠医学专家讨论了SDB诊断和治疗中所用术语的恰当定义、家庭睡眠测试与多导睡眠图的使用、研究SDB设备时的临床试验设计问题，以及用于诊断和监测SDB的数字健康技术的当前和未来趋势。该小组在各个医学专科领域的广泛临床专业知识和经验，为SDB设备的临床试验设计提供了有用且重要的见解。
