Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States.
Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, United States.
JMIR Res Protoc. 2024 Sep 19;13:e60769. doi: 10.2196/60769.
Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), nonadherence is common. Numerous factors influence PAP use, including a belief that the therapy is important and effective. In theory, providing information to patients about their blood oxygen levels during sleep (which may be low when PAP is not used), juxtaposed to information about their PAP use, may influence a patient's beliefs about therapy and increase PAP use. With the advent of consumer wearable smartwatches' blood oxygen saturation monitoring capability (and the existing routine availability of PAP use data transmitted via modem to clinical dashboards), there is an opportunity to provide this combination of information to patients.
This study aims to test the feasibility, acceptability, and preliminary efficacy of the Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP), a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA in a pilot randomized waitlist-controlled clinical trial.
This is a single-blinded randomized controlled trial. We will randomize 50 individuals with a history of OSA, who receive care from a Department of Veterans Affairs medical center in the Los Angeles area and are nonadherent to prescribed PAP therapy, into either an immediate intervention group or a waitlist control group. During a 28-day intervention, the participants will wear a study-provided consumer wearable device and complete a weekly survey about their OSA symptoms. A report that summarizes consumer wearable-provided oxygen saturation values, PAP use derived from modem data, and patient-reported OSA symptoms will be prepared weekly and shared with the patient. The immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; 1 week after treatment for the immediate intervention group and repeat baseline for the waitlist control group) and week 11 (T5; follow-up for the immediate intervention group and 1 week after treatment for the waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes per night) from T1 to T3. The primary analysis will be a comparison of the primary outcome between the immediate intervention and the waitlist control groups (intention-to-treat design), using a 2-sample, 2-sided t test on change scores (unadjusted).
Recruitment began in October 2023. Data analysis is expected to begin in October 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis.
Findings from the study may provide additional insights on how patients with OSA might use patient-generated health data collected by consumer wearables to inform self-management of OSA and possibly increase their use of PAP therapy.
ClinicalTrials.gov NCT06039865; https://clinicaltrials.gov/study/NCT06039865.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60769.
尽管正压通气（PAP）疗法被认为是阻塞性睡眠呼吸暂停（OSA）的一线治疗方法，但患者的依从性普遍较差。许多因素会影响 PAP 的使用，包括对治疗重要性和有效性的信念。理论上，向患者提供有关其睡眠期间血氧水平的信息（如果不使用 PAP，血氧水平可能较低），并提供有关其 PAP 使用情况的信息，可能会影响患者对治疗的信念，并增加 PAP 的使用。随着消费者可穿戴智能手表血氧饱和度监测功能的出现（以及通过调制解调器传输到临床仪表板的 PAP 使用数据的现有常规可用性），为患者提供这种信息组合的机会已经到来。
本研究旨在测试慢性护理管理与可穿戴设备在接受正压气道治疗（mPAP）的患者中的可行性、可接受性和初步疗效，该方案通过消费者级可穿戴设备增强当前 PAP 治疗数据，以促进 OSA 患者的 PAP 治疗自我管理，这是一项单盲随机对照临床试验。
这是一项单盲随机对照临床试验。我们将随机招募 50 名曾有 OSA 病史、在洛杉矶地区退伍军人事务医疗中心接受治疗且不遵守 PAP 治疗规定的患者，将他们分为立即干预组或候补名单对照组。在 28 天的干预期间，参与者将佩戴研究提供的消费者可穿戴设备，并每周完成一次关于其 OSA 症状的调查。每周将编制一份报告，总结消费者可穿戴设备提供的血氧饱和度值、从调制解调器数据中得出的 PAP 使用情况以及患者报告的 OSA 症状，并与患者共享。立即干预组将在随机分组后立即开始干预（T1）。评估将在第 5 周（T3；立即干预组治疗后 1 周，候补名单对照组重复基线）和第 11 周（T5；立即干预组随访，候补名单对照组治疗后 1 周）进行。主要结局是从 T1 到 T3 的 7 天 PAP 依从性（平均每晚分钟数）的变化。主要分析将是对立即干预组和候补名单对照组之间的主要结局进行比较（意向治疗设计），使用未调整的两组两样本双侧 t 检验比较变化分数。
招募工作于 2023 年 10 月开始。预计将于 2024 年 10 月完成所有随访时开始数据分析，在完成数据分析后，将提交一份总结试验结果的手稿。
该研究的结果可能提供更多关于 OSA 患者如何使用消费者可穿戴设备收集的患者生成健康数据来告知 OSA 自我管理并可能增加他们对 PAP 治疗的使用的见解。
ClinicalTrials.gov NCT06039865；https://clinicaltrials.gov/study/NCT06039865。
国际注册报告标识符（IRRID）：DERR1-10.2196/60769。
