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。据估计，阻塞性睡眠呼吸暂停综合症影响18-40人 美国有70万成年人和0.7%-3%的儿童。阻塞性睡眠呼吸暂停会导致疲倦、抑郁和疲劳， 几种相关的常见合并症。据信，80%以上的阻塞性睡眠呼吸暂停综合征仍未确诊。这个 OSA的患病率随着年龄的增长而增加，如果不进行治疗，就会增加心脏死亡的风险 几种合并症。一种负担得起的、可用的、FDA批准的、易于使用的非处方OSA 筛查工具将允许对高危个人进行更大程度的筛查，从而实现更大比例的此类 有必要鼓励个人寻求针对其病情的治疗。这种设备在药店的广泛销售 消费者健康渠道将额外允许贫困社区获得高质量的 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设备，可以测量 睡眠时的呼吸和运动。它是一款1.5 x 1.5 x 0.2英寸无线产品包，采用四项关键技术： (A)一个可调麦克风；(B)一个三轴加速度计；(C)测量睡眠事件的嵌入式算法； 和(D)丙烯酸粘合剂。该产品是FDA批准的非处方药设备，患者 可以在睡眠时穿戴，醒来时会有红色、黄色或绿色的分数，具体取决于他们的睡眠呼吸暂停 风险状态。产品特点包括居家、易用、非侵入性、无线、一次性和低成本 成本不到75美元，测试结果很容易理解。第一阶段STTR奖证明了 该仪器可成功筛查成人阻塞性睡眠呼吸暂停综合征，对金黄色葡萄球菌的敏感性和特异性均在70%以上。 标准的多导睡眠图数据。在这个二期工程中，我们将：1)实施良好的制造规范 和质量体系控制(国际标准化组织13485)；2)开发和实施新的算法，以检测来自 声音和运动数据；3)开发一款无线蓝牙应用程序，从可穿戴设备上获取无线数据 传感器并在移动设备上提供数据可视化；以及4)对照家庭验证我们的数据和调查结果 密歇根大学睡眠障碍中心的一项临床研究中的睡眠测试和多导睡眠图。 到2018年，全球OSA市场将达到84亿美元。市场当前没有 负担得起，易于使用的柜台家庭OSA筛查设备。提高对OSA的认识 它的影响，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。伙伴关系 有了更大的领先睡眠治疗公司，Zansors产品的销售和分销将得到帮助。

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.