Oral Appliance Compliance & Efficacy (ACE) System

描述（由申请人提供）：阻塞性睡眠呼吸暂停（OSA）导致数百万人无法获得充足或安宁的睡眠，导致生产力下降，车祸，并被认为是慢性阻塞性肺病和其他疾病的合并症。打鼾是阻塞性睡眠呼吸暂停综合症的典型症状，也会扰乱睡眠伴侣，其临床表现可能与患者本人相似。目前已批准的治疗打鼾和轻度至中度阻塞性睡眠呼吸暂停的方法之一是使用口腔器械。与传统的气道正压（PAP）设备相比，口腔器械具有许多优点，包括无噪音，对许多人来说身体上的烦恼较少，易于携带。然而，口腔器械也缺乏必要的能力来监测遵守和有效性，这需要满足法规要求并进行基于人群的有效性研究。拟议的工作将设计、开发和制作一个新系统的原型，该系统将纳入多种口腔器具，并将专门监测依从性和有效性。第一阶段将成功地设计，开发和原型系统，可以纳入口腔器具。第二阶段将制定和实施扩展的临床方案，以测试和评估各种口腔器具的临床依从性和有效性。

DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA) accounts for millions of people not getting adequate or restful sleep and result in loss of productivity, car accidents, and is recognized as a co-morbidity of COPD and other diseases. Snoring, a typical symptom of OSA is also a disruption to a sleeping partner with potentially similar clinical manifestations as the afflicted person themselves. One of the existing approved medical treatment options for snoring and mild to moderate OSA include oral appliances. Oral appliances offer many advantages over the traditional positive airway pressure (PAP) type of devices, including no noise, less physically annoying (to many), and ease of portability. However, oral appliances also lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. The proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness. The phase I will successfully design, develop, and prototype a system that can be incorporated into the oral appliances. A phase II will develop and implement extended clinical protocols for testing and evaluating the clinical compliance and effectiveness of various oral appliances.