Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), non-adherence 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 wearable devices’ 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. OBJECTIVE The Chronic care management with wearable devices in patients prescribed Positive Airway Pressure therapy (mPAP) study is a pilot randomized waitlist-controlled trial testing the feasibility, acceptability, and preliminary efficacy of a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA. METHODS 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 to Immediate intervention or Waitlist control. 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. Immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; one-week post-treatment for Immediate intervention group and repeat baseline for Waitlist control group) and week 11 (T5; follow-up for Immediate intervention group and one-week post-treatment for Waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes/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 two-sample t-test on change scores (unadjusted). RESULTS Recruitment began in October 2023. Data analysis is expected to begin in September 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis. CONCLUSIONS 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. CLINICALTRIAL ClinicalTrials.gov NCT06039865