LOW-COST FLEXIBLE SKIN-ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING

 描述(申请人提供)：这项研究的目标是进一步开发和验证Somna Patch(Tm)，这是一种创新的柔性皮肤粘连设备，可以诊断阻塞性睡眠呼吸暂停症和其他睡眠呼吸紊乱。该公司的目标是提供该设备和SomnaCloud(Tm)睡眠数据分析软件作为一个完整的解决方案。睡眠呼吸暂停是一种常见疾病，会导致高血压、糖尿病和心血管疾病。睡眠呼吸障碍通常通过多导睡眠图和便携式睡眠监测器进行诊断。现有的诊断解决方案价格昂贵，而且绝大多数患者都不容易获得，其中80%的患者仍未得到诊断。该项目包括一项大型多中心临床验证研究。这项临床研究将招募有睡眠呼吸障碍风险的患者。具体目的是改进Somna Patch(Tm)设备和Somna Cloud软件，并明确证明诊断解决方案的临床有效性。如果拟议的工作成功进行，该诊断解决方案将有望获得FDA的监管批准，并将作为一种易于使用、廉价、可报销的睡眠呼吸障碍诊断工具集成到临床实践中。Somnarus产品可以帮助接触到目前未诊断出的患者，并有助于防止未经治疗的阻塞性睡眠呼吸暂停症造成的破坏性长期后果。

 DESCRIPTION (provided by applicant): The objective of this study is to further develop and validate the SomnaPatch(tm), an innovative flexible skin-adhesive device that diagnoses obstructive sleep apnea and other sleep disordered breathing. The company's goal is to offer the device and the SomnaCloud(tm) sleep data analysis software as a complete solution. 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 project includes a large multi-center clinical validation study. Patients at risk for sleep disordered breathing will e recruited for the clinical study. The specific aims are to improve the SomnaPatch(tm) device and the SomnaCloud software and to definitively prove clinical validity of the diagnostic solution. If the proposed work is carried out successfully, the diagnostic solution will be poised to gain regulatory approval by FDA and to be integrated into clinical practice as an easy-to-use, inexpensive, reimbursable tool for the diagnosis of sleep disordered breathing. The Somnarus products can help reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated obstructive sleep apnea.