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合装置的可行性，该装置可诊断阻塞性睡眠呼吸暂停和其他睡眠呼吸障碍。睡眠呼吸暂停是一种常见的疾病，可导致高血压、糖尿病和心血管疾病。睡眠呼吸障碍通常通过多导睡眠图和便携式睡眠监测仪进行诊断。现有的诊断解决方案是昂贵的，并不容易获得的绝大多数患者，其中百分之八十的人仍然未确诊。这项试点临床研究旨在比较创新的诊断设备"SomnaPatch”与多导睡眠图。本研究将招募睡眠呼吸障碍患者（阻塞性和中枢性睡眠呼吸暂停和Cheyne-Stokes呼吸）和健康对照。具体目的是改进SomnaPatch装置的设计;并评估SomnaPatch装置与多导睡眠图之间的一致性。如果这项研究表明这两种技术之间存在很好的一致性，那么类似创可贴的SomnaPatch设备可能会被整合到睡眠专家，牙医和初级保健医生的临床实践中，作为一种易于使用，廉价，可报销的工具，用于诊断睡眠呼吸障碍。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.