FLEXIBLE SKIN-ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING

描述（由申请人提供）：本研究的目的是测试一种创新的柔性皮肤粘附装置用于诊断阻塞性睡眠呼吸暂停和其他睡眠呼吸障碍的可行性。睡眠呼吸暂停是一种常见的疾病，会导致高血压、糖尿病和心血管疾病。睡眠呼吸障碍通常用多导睡眠描记仪和便携式睡眠监测仪诊断。现有的诊断方法价格昂贵，而且绝大多数患者无法轻易获得，其中80%的患者仍未得到诊断。这项试点临床研究旨在比较创新的诊断设备“SomnaPatch”和多导睡眠图。患有睡眠呼吸障碍（阻塞性和中枢性睡眠呼吸暂停和Cheyne-Stokes呼吸）的患者和健康对照者将被招募参加本研究。具体目的是改进“SomnaPatch”设备的设计；并评估“睡眠贴片”设备和多导睡眠描记仪之间的一致性。如果这项研究表明这两种技术之间存在良好的一致性，那么这种类似创可贴的SomnaPatch设备就有可能作为一种易于使用、价格低廉、可报销的诊断睡眠呼吸障碍的工具，被睡眠专家、牙医和初级保健医生纳入临床实践。SomnaPatch可以帮助目前未确诊的患者，并帮助预防未经治疗的阻塞性睡眠呼吸暂停带来的破坏性长期后果。

DESCRIPTION (provided by applicant): The objective of this study is to test the feasibility of an innovative flexible skin-adhesive device that diagnoses obstructive sleep apnea and other sleep disordered breathing. Sleep apnea is a common disease that leads to hypertension, diabetes and cardiovascular disease. Sleep disordered breathing is commonly diagnosed with polysomnography and portable sleep monitors. The existing diagnostic solutions are expensive and are not readily available to the vast majority of patients, eighty percent of whom remain undiagnosed. This pilot clinical research study is designed to compare the innovative diagnostic device SomnaPatch" with polysomnography. Patients with sleep disordered breathing (obstructive and central sleep apneas and Cheyne-Stokes respiration) and healthy controls will be recruited for this study. The specific aims are to improve the design of the SomnaPatch" device; and to assess the agreement between the SomnaPatch" device and polysomnography. If this research study shows good agreement between the two techniques, the BandAid-like SomnaPatch" device can potentially be integrated into clinical practice of sleep specialists, dentists and primary care physicians as an easy-to-use, inexpensive, reimbursable tool for the diagnosis of sleep disordered breathing. SomnaPatch" can reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated obstructive sleep apnea.