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

摘要 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18-40 在美国，100万成年人和0.7-3%的儿童。阻塞性睡眠呼吸暂停综合症导致疲劳、抑郁和疲劳， 几种相关的常见合并症。据信，超过80%的OSA仍然未被诊断。的 OSA的患病率随着年龄的增长而增加，如果不治疗，心脏死亡的风险增加， 多种合并症。一种经济实惠、可用、FDA批准且易于使用的非处方OSA 筛查工具将允许对高危人群进行更大程度的筛查， 个人寻求治疗他们的条件。这种设备在药店的广泛使用 消费者健康网点将使贫困社区获得高质量的 睡眠呼吸暂停综合征的诊断Zansors开发了一种生物工程半导体设备， 睡眠时的呼吸和运动。这是一个1.5 x 1.5 x 0.2英寸的无线封装，采用四项关键技术： (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; 和（d）丙烯酸粘合剂。该产品被设计为FDA批准的非处方器械， 可以在睡眠期间佩戴，并且根据他们的睡眠呼吸暂停而以红色、黄色或绿色的颜色评分醒来 风险状况。产品特点包括家用、易用、无创、无线、一次性、低 成本低于75美元，测试结果易于理解。第一阶段的STTR奖励表明， 该设备可以成功地在成人中筛查OSA，对金的敏感性和特异性超过70%， 标准多导睡眠图数据。在第二期项目中，我们将1）实施良好生产规范 和质量体系控制（ISO 13485）; 2）开发和实施新的算法，以检测呼吸不足， 声音和运动数据; 3）开发一个无线蓝牙应用程序，从可穿戴设备获取无线数据 传感器，并在移动的设备上提供数据可视化;以及4）验证我们的数据和调查结果与家庭 睡眠测试和多导睡眠图在密歇根大学睡眠障碍中心的临床研究。 到2018年，全球OSA市场将达到84亿美元。市场目前没有 价格实惠，易于使用的非处方家庭OSA筛查设备。提高对OSA的认识 及其影响，以及服务不足人群的强烈未满足需求有利于市场渗透。伙伴关系 与大型领先的睡眠治疗公司合作将有助于Zansors产品的销售和分销。

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.