Wireless sensor and telemedicine to screen for sleep apnea in elderly adults

无线传感器和远程医疗可筛查老年人的睡眠呼吸暂停

• 批准号: 9331733
• 负责人: J. Todd Arnedt
• 金额: $ 68.9万
• 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 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9331733
• 关键词: Accelerometer; Adhesives; Adoption; Adult; Affect; Age; Algorithmic Software; Algorithms; Apnea; Apple; Area; Award; Awareness; Biomedical Engineering; Breathing; Cardiac; Caring; Characteristics; Child; Clinical; Clinical Research; Collaborations; Color; Communication; Communities; Comorbidity; Companions; Data; Databases; Detection; Devices; Diagnostic; Elderly; Electronic Health Record; Engineering; Event; FDA approved; Fatigue; Goals; Gold; Grant; Health; Health Insurance Portability and Accountability Act; Home environment; Human; Individual; Industrialization; Knowledge; Laboratories; Measures; Mental Depression; Methods; Michigan; Microprocessor; Motion; Movement; Obstructive Sleep Apnea; Patients; Penetration; Performance; Phase; Polysomnography; Population; Prevalence; Privacy; Reporting; Research; Risk; Sales; Security; Semiconductors; Sensitivity and Specificity; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Small Business Innovation Research Grant; Small Business Technology Transfer Research; System; Technology; Telemedicine; Test Result; Testing; Underserved Population; United States National Institutes of Health; Universities; Visual; Wireless Technology; base; cost; dashboard; data visualization; design; encryption; evidence base; experience; handheld mobile device; health disparity; indexing; innovation; low socioeconomic status; mHealth; mobile application; mortality; novel; screening; sensor; sound; technological innovation; tool

ABSTRACT 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. The prevalence of OSA increases with age, and if untreated increases the risk of cardiac mortality as well as several comorbidities. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool will allow greater screening of at-risk individuals, enabling a greater proportion of such individuals to seek treatment for their condition. The widespread availability of this device through drugstores and consumer health outlets will additionally allow underprivileged communities access to a high-quality screening tool for sleep apnea. Zansors has developed a bioengineered, semiconductor device that measures breathing and movement during sleep. It is a 1.5 x 1.5 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. The product is 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 risk status. The product features include home-based, easy-to-use, non-invasive, wireless, disposable, and low cost at less than $75, with easily understandable test results. A Phase I STTR award demonstrated that that this device can successfully screen for OSA in adults, with over 70% sensitivity and specificity against gold- standard polysomnography data. In this Phase II project, we will 1) implement Good Manufacturing Practice and quality systems control (ISO 13485); 2)develop and implement novel algorithms to detect hypopneas from sound and motion data ; 3)develop a wireless Bluetooth app that takes the wireless data from the wearable sensor and provides data visualizations on mobile devices ; and 4) validate our data and findings against home sleep testing and polysomnography in a clinical study at the University of Michigan Sleep Disorders Center. 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.

抽象的 阻塞性睡眠呼吸暂停（OSA）是最常见的睡眠呼吸暂停类型。 OSA影响估计的18-40 在美国所有儿童中，有百万成年人和0.7-3％。 OSA导致疲劳，抑郁和疲劳，并具有 几种相关的常见合并症。据信，超过80％的OSA仍未诊断。这 OSA的患病率随着年龄的增长而增加，如果未经治疗会增加心脏死亡率的风险 几种合并症。负担得起的，可用的FDA批准且易于使用的非处方OSA 筛查工具将允许对处于危险的个人进行更多的筛查，从而使更多此类 个人为自己的状况寻求治疗。该设备通过药房的广泛可用性 消费者健康渠道还将允许贫困社区进入高质量 睡眠呼吸暂停的筛选工具。 Zansors开发了一种生物工程的半导体设备，以测量 睡眠期间的呼吸和运动。它是使用四个关键技术的1.5 x 1.5 x 0.2英寸无线包装： （a）可调节的麦克风； （b）3轴加速度计； （c）测量睡眠事件的嵌入式算法； （d）丙烯酸粘合剂。该产品被设计为患者的FDA批准的非处方设备 睡眠期间可以磨损，并以红色，黄色或绿色的颜色评分醒来，具体取决于他们的睡眠呼吸暂停 风险状态。产品功能包括家庭基础，易于使用，非侵入性，无线，一次性和低 费用不到75美元，具有易于理解的测试结果。 I期STTR奖证明了这一点 该设备可以在成人中成功筛选OSA，具有超过70％的敏感性和针对金的特异性。 标准的多个术数据。在此第二阶段项目中，我们将1）实施良好的制造实践 和质量系统控制（ISO 13485）； 2）开发和实施新型算法以检测从 声音和运动数据； 3）开发一个无线蓝牙应用程序，该应用程序从可穿戴设备中获取无线数据 传感器并在移动设备上提供数据可视化； 4）验证我们的数据和发现对家庭的发现 在密歇根大学睡眠障碍中心的临床研究中，睡眠测试和多个术语表。 到2018年，全球OSA市场将达到84亿美元。目前该市场没有 负担得起的，易于使用的非处方家庭OSA筛选设备。提高对OSA的认识 及其影响力，以及服务不足的人群的强烈未满足的需求有利于市场渗透。伙伴关系 随着领先的睡眠治疗公司，公司将有助于Zansors产品的销售和分销。