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)
Authors: Mak Selene , Ash Garrett , Liang Li-Jung , Der-McLeod Erin , Ghadimi Sara , Kewalramani Anjali , Naeem Saadia , Zeidler Michelle , Fung Constance 
Published: May 2024

BACKGROUND

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.

OBJECTIVE

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.

METHODS

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 <i>t</i> test on change scores (unadjusted).

RESULTS

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.

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; https://clinicaltrials.gov/study/NCT06039865

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/60769