Clinical Trial

Wearable Device to Promote CPAP Adherence in Obstructive Sleep Apnea (OSA) Patients

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Record status
This record was last updated January 30, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this study type: clinical trial is to evaluate adherence for CPAP used with wearable device in OSA patients comparing with controlled group; could include any of the following: adult patients (≥ 19 yr of age) with moderate to severe OSA (AHI ≥ 15 events/hr by polysomnography (PSG), according to the American Academy of Sleep Medicine, diagnosed at the sleep clinic in Ramathibodi hospital, patients with OSA who are first time to prescribed CPAP treatment and in the waiting process for their machine. The main question it aims to answer is: Could a wearable device help increase the adherence of CPAP in obstructive sleep apnea patients? Primary outcome is adherence for CPAP: time usage per day(min) and % usage \> 4 hours Secondary outcome are access sleepiness and quality of sleep by questionnaire (ESS and PSQI) in Thai version, the correlation between wearable-derived and CPAP data: Total sleep time(min), sleep stage (light, deep and REM), and health information: heart rate, oxygen saturation, stress, sleep score and step counting If there is a comparison group: Researchers will compare wearable group and control group to see the effect of wearable to increase adherence of CPAP used. Participants will * Divide into two group by randomization using 4 block randomization * In wearable group, the participants will receive wearable and download application, they allow to access all the time * In control group, the participants will receive wearable and download application, but they will not allow to access until they come to hospital for follow up at the end of the study
Trial Details
NCT Number NCT07377968
Lead Sponsor Ramathibodi Hospital
Conditions Obstructive Sleep Apnea (OSA)
Enrollment 80 participants
Start Date 2026-01-06
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-30