Oral Appliance Compliance & Efficacy (ACE) System

口腔矫治器合规性

• 批准号: 8592503
• 负责人: MATTHEW D. TARLER
• 金额: $ 21.1万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8592503
• 关键词: Accidents; Accounting; Charge; Chronic Obstructive Airway Disease; Clinical; Clinical Protocols; Communication; Comorbidity; Coupling; Data; Data Analyses; Devices; Disease; Docking; Effectiveness; Feedback; Head; Health Personnel; Hour; Life; Medical; Methods; Microprocessor; Monitor; Noise; Obstructive Sleep Apnea; Oral; Oral cavity; Patient Self-Report; Patients; Persons; Phase; Polysomnography; Positioning Attribute; Questionnaires; Reading; Reporting; Research; Respiration; Sleep; Snoring; Symptoms; System; Temperature; Testing; Time; Treatment Effectiveness; Treatment outcome; Variant; Wireless Technology; Work; base; compliance behavior; design; effectiveness research; monitoring device; population based; portability; pressure; productivity loss; prototype; public health relevance; sensor; success; treatment duration

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.

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休息的睡眠，并导致生产力下降，车祸，并被认为是COPD和其他疾病的合并症。打鼾是阻塞性睡眠呼吸暂停综合征的一个典型症状，也是对睡眠伴侣的一种干扰，其临床表现可能与受影响的人本身相似。现有批准的治疗打鼾和轻度至中度阻塞性睡眠呼吸暂停综合症的医疗选择之一包括口腔矫正器。与传统的气道正压通气（PAP）类型的设备相比，口腔器具具有许多优点，包括无噪音、（对许多人来说）较少的身体烦恼以及易于携带。然而，口腔矫治器还缺乏监测符合性和有效性所需的能力，这些能力是满足监管要求和进行基于人群的有效性研究所需的。拟议的工作将设计，开发和原型一个新的系统，将被纳入多个口腔用具，并将专门监测遵守和有效性。第一阶段将成功地设计，开发和原型系统，可以纳入口腔用具。第二阶段则会发展和推行扩展临床测试程序，以测试和评估各种口腔用具的临床依从性和成效。