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

描述（由申请人提供）：阻塞性睡眠呼吸暂停（OSA）是最常见的睡眠呼吸暂停类型。在美国，估计有1800万至4000万成年人和0.7%至3%的儿童患有OSA。OSA导致疲倦、抑郁和疲劳，并且具有几种相关的常见合并症。据信，超过80%的OSA仍然未被诊断。贫困和弱势群体患睡眠障碍的风险更高，包括OSA，即使考虑到其他风险因素。一个负担得起的，可用的，FDA批准的和易于使用的非处方OSA筛查工具将允许对高危人群进行更大的筛查，特别是在社会经济地位低的服务不足的社区，希望鼓励更多的此类人群寻求治疗。通过药店和消费者健康网点广泛提供经批准的非处方、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开发了一种生物工程半导体原型，可以测量睡眠期间的呼吸和运动。这是一个1.5 x 2.5 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）用于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STTR赠款将证明功能性设备的可行性和初步性能的试点研究。该产品将被设计为FDA批准的非处方器械，患者可以在睡眠期间佩戴，并根据其睡眠呼吸暂停状态以红色、黄色或绿色的颜色评分醒来。该产品的特点包括基于家庭的易于使用，非侵入性，无线，一次性和低成本约20 -50美元，并提出了易于理解的测试结果。在第二阶段，我们将1）开发一个无线蓝牙应用程序，从可穿戴传感器获取无线数据，并在移动的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。市场上目前没有负担得起的、易于使用的非处方的基于家庭的OSA筛查装置。对OSA及其影响的认识不断提高，以及服务不足人群的强烈未满足需求有利于市场渗透。与大型领先睡眠治疗公司的合作将有助于Zansors产品的销售和分销。

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.