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

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