FLEXIBLE SKIN-ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING

用于诊断睡眠呼吸障碍的柔性皮肤贴片

• 批准号: 8715335
• 负责人: Maria Merchant
• 金额: $ 30.37万
• 依托单位: SOMNARUS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8715335
• 关键词: Adhesives; Agreement; Blood; Cardiovascular Diseases; Central Sleep Apnea; Cheyne-Stokes Respiration; Clinical Research; Data; Data Analyses; Dentists; Development; Device Designs; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Goals; Health; Health Care Costs; Heart Diseases; Heart Rate; Home environment; Hypertension; Instruction; Measures; Methods; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nose; Obstructive Sleep Apnea; Oxygen; Patients; Phase; Photoplethysmography; Physiological; Pilot Projects; Polysomnography; Preparation; Primary Care Physician; Primary Health Care; Quality of life; Records; Recruitment Activity; Reporting; Research Project Grants; Respiration Disorders; Respiratory Therapy; Risk; Signal Transduction; Skin; Sleep; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Solutions; Specialist; Techniques; Technology; Test Result; Testing; Time; TimeLine; Training; base; clinical practice; design; flexibility; improved; innovation; prevent; prototype; public health relevance; research clinical testing; research study; respiratory; tool

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.

描述(申请人提供)：这项研究的目的是测试一种创新的柔性皮肤粘连设备的可行性，该设备可以诊断阻塞性睡眠呼吸暂停和其他睡眠障碍呼吸。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。这项试验性的临床研究旨在比较创新的诊断设备Somna Patch和多导睡眠图。这项研究将招募睡眠障碍呼吸患者(阻塞性和中枢性睡眠呼吸暂停和Cheyne-Stokes呼吸)和健康对照组。具体目的是改进Somna Patch“设备的设计；并评估Somna Patch”设备和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有很好的一致性，这种类似创可贴的Somna Patch“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、可报销的睡眠呼吸障碍诊断工具。Somna Patch“可以接触到目前未诊断的患者，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。