Wireless sensor patch for reducing barriers to in-home sleep apnea screening

无线传感器贴片可减少家庭睡眠呼吸暂停筛查的障碍

• 批准号: 8723589
• 负责人: J. Todd Arnedt
• 金额: $ 21万
• 依托单位: ZANSORS, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-04 至 2015-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8723589
• 关键词: Accounting; Adhesives; Adult; Affect; Algorithms; Area; Awareness; Biomedical Engineering; Breathing; Caring; Child; Clinical; Clinical Research; Collaborations; Color; Communities; Comorbidity; Computers; Data; Detection; Devices; Diabetes Mellitus; Disadvantaged; Disease; Economics; Evaluation; Event; FDA approved; Fatigue; Goals; Gold; Grant; Health; Home environment; Hypertension; Imagery; Individual; Knowledge; Marketing; Measurement; Measures; Medical; Medical Device; Mental Depression; Michigan; Minority; Motion; Movement; Neck; Obesity; Obstructive Sleep Apnea; Patients; Pattern; Penetration; Performance; Phase; Pilot Projects; Polysomnography; Population; Prevalence; Privacy; Research; Risk; Risk Factors; Sales; Semiconductors; Sensitivity and Specificity; Severities; Simulate; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Small Business Technology Transfer Research; Solutions; Symptoms; Technology; Test Result; Testing; Time; Underserved Population; Universities; Validation; Wireless Technology; base; commercial application; cost; design; evidence base; handheld mobile device; health disparity; high risk; low socioeconomic status; prototype; public health relevance; research study; screening; sensor; social; sound; technological innovation; tool; tv watching

DESCRIPTION (provided by applicant): Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. OSA results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool will allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The widespread availability of an approved over-the-counter, affordable, easy-to-use sleep apnea screening device through drugstores and consumer health outlets will allow underprivileged communities access to a high-quality screening tool for sleep apnea. Zansors has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies: (a) an adjustable microphone; (b) a 3-axis accelerometer; (c) embedded algorithms to measure sleep events; and (d) acrylic adhesive. A Phase I STTR grant will demonstrate feasibility of the functional device and preliminary performance from a pilot study. The product will be designed as a FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The product features include home based easy to use, non-invasive, wireless, disposable, and low cost at about $20-50 and presents easily understandable test results. In the Phase II, we will 1) develop a wireless Bluetooth app that takes the wireless data from the wearable sensor and provides data visualizations on mobile devices; 2) perform validation clinical studies at the University of Michigan. The worldwide OSA market will reach $8.4 billion by 2018. The marketplace currently does not have an affordable, easy-to-use over- the-counter home-based OSA screening device. Increasing awareness of OSA and its impact, and a strong unmet need in underserved populations favor market penetration. Partnerships with larger leading sleep treatment companies will help the sales and distribution of the Zansors product.

描述(申请人提供)：阻塞性睡眠呼吸暂停(OSA)是最常见的睡眠呼吸暂停类型。据估计，美国约有1800万至4000万成年人和0.7%至3%的儿童患有阻塞性睡眠呼吸暂停综合症。阻塞性睡眠呼吸暂停会导致疲劳、抑郁和疲劳，并伴有几种常见的合并症。据信，80%以上的阻塞性睡眠呼吸暂停综合征仍未确诊。即使考虑了其他风险因素，贫困和弱势社区患睡眠障碍的风险也更高，包括阻塞性睡眠呼吸暂停综合症。一种负担得起的、可获得FDA批准的、易于使用的OSA非处方药筛查工具将允许对高危个人进行更大程度的筛查，特别是在社会经济地位较低、服务不足的社区，希望能鼓励更多此类个人寻求针对其病情的治疗。通过药店和消费者健康渠道广泛提供经批准的非处方药、负担得起、易于使用的睡眠呼吸暂停筛查设备，将使贫困社区能够获得高质量的睡眠呼吸暂停筛查工具。Zansors已经开发出一种生物工程半导体原型，可以测量睡眠时的呼吸和运动。它是一个1.5x2.5x0.2英寸的无线封装，使用了四项关键技术：(A)可调麦克风；(B)3轴加速度计；(C)测量睡眠事件的嵌入式算法；以及(D)丙烯酸粘合剂。第一阶段的STTR赠款将从试点研究中证明该功能装置的可行性和初步性能。该产品将被设计为FDA批准的非处方药设备，患者可以在睡眠期间佩戴，醒来时颜色分数为红色、黄色或绿色，具体取决于他们的睡眠呼吸暂停状态。该产品的特点包括基于家庭的易于使用、非侵入性、无线、一次性和低成本，价格约为20-50美元，并提供易于理解的测试结果。在第二阶段，我们将1)开发一款无线蓝牙应用程序，从可穿戴传感器获取无线数据，并在移动设备上提供数据可视化；2)在密歇根大学进行验证临床研究。到2018年，全球OSA市场将达到84亿美元。目前市场上还没有负担得起的、易于使用的非处方药家庭OSA筛查设备。对OSA及其影响的认识不断提高，以及服务不足人群中强烈的未得到满足的需求，有利于市场渗透。与更大的领先睡眠治疗公司的合作将有助于Zansors产品的销售和分销。