Abstract:

Obstructive sleep apnea (OSA) is a high prevalent chronic disease that may lead to many complications, and cause great potential harm to health. Epidemiological studies have showed that OSA is closely related to the development of various cardiovascular diseases. There are about 66 million patients with moderate to severe OSA in China, but 80% of potential OSA patients have not been diagnosed and treated in time. OSA is mainly diagnosed and treated in a hospital-based sleep center currently, as the process is time-consuming and laborious, which may be lead to a delay in diagnosis and treatment of many patients. Supported by the development of Internet of Things, Internet technologies and other emerging technologies, remote medicine has been increasingly used in the diagnosis and management of chronic diseases owing to its advantages of easy access, interactivity, high efficiency, resource sharing, service continuity and without space-time constraints. Our center has initially built a management system for remote diagnosis and treatment of OSA, but its clinical efficacy and economic value need to be further verified. We designed a randomized controlled trial protocol to assess whether the clinical benefits of the low-cost remote healthcare model are similar to those of the traditional healthcare model by comparing them in terms of clinical efficacy and health economic benefits, hoping to provide a reference for the efficient use of medical resources and further promotion of remote diagnosis and treatment of chronic diseases.

Key words: Sleep apnea, obstructive, Telemedicine, Equivalence trial, Randomized controlled trial, Clinical protocols, Non-inferiority randomized controlled trial

摘要：

阻塞性睡眠呼吸暂停（OSA）是一种慢性病，其患病率高、并发症多、潜在危害大。流行病学研究显示，OSA与多种心血管疾病的发生发展密切相关。目前，我国中重度OSA患者达6 600万，然而约有80%的OSA潜在患者尚未得到及时诊断和治疗。当前OSA的诊断和治疗主要在医院的睡眠中心完成，此过程耗时费力，导致大量患者延误诊治。随着物联网和互联网等新兴技术的发展，远程医疗以其便捷、交互性、高效、共享、连贯及突破时空限制的优势越来越多的被应用于慢性病的诊治与管理中。目前，本中心已初步构建OSA的远程诊疗管理体系，但其临床效能及卫生经济学价值尚需进一步验证。本研究将设计随机对照试验比较OSA新型远程医疗模式和传统医疗模式下的临床效能和卫生经济效益，探讨OSA的远程诊疗模式在使用更低医疗成本中的临床获益是否不劣于传统诊疗模式，以期为医疗资源的高效利用、慢性病远程诊疗的进一步推广奠定基础。

关键词: 睡眠呼吸暂停，阻塞性, 远程医学, 等效性试验, 随机对照试验, 临床方案, 非劣效随机对照试验