Edson College of Nursing and Health Innovation, Arizona State University, United States of America.
College of Health Solutions, Arizona State University, United States of America.
Contemp Clin Trials. 2020 Feb;89:105908. doi: 10.1016/j.cct.2019.105908. Epub 2019 Dec 14.
Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability.
METHODS/DESIGN: To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA.
SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes.
正压通气(PAP)疗法是阻塞性睡眠呼吸暂停(OSA)的金标准治疗方法,这是一种影响 6-13%成年人的慢性疾病。然而,坚持使用 PAP 疗法具有挑战性,目前改善依从性的方法效果有限且扩展性不足。
方法/设计:为了促进 PAP 依从性,我们开发了 SleepWell24,这是一种多组件、基于证据的智能手机应用程序,通过云 PAP 机器和可穿戴传感器数据提供有关 PAP 使用和睡眠/体力活动模式的客观生物反馈,并提供行为改变策略和 PAP 治疗界面使用问题的故障排除。这项随机对照试验将评估 SleepWell24 在 OSA 新诊断患者 PAP 治疗的前 60 天中与常规护理对照组相比的可行性、可接受性和初步疗效。
SleepWell24 是一种创新的、多组件的行为改变干预措施,旨在作为一种自我管理方法,解决新用户对 PAP 治疗依从性的心理社会决定因素。结果将指导未来评估众多以患者为中心和临床结局的更长时间试验。