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NOT YET RECRUITING
NCT07377968
NA

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

Sponsor: Ramathibodi Hospital

View on ClinicalTrials.gov

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

Official title: Efficacy of Wearable Device to Promote CPAP Adherence in Patients With Obstructive Sleep Apnea (OSA); A Randomized Controlled Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-06

Completion Date

2026-06-30

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DEVICE

garmin vivoactive 5 with self-monitoring data

patients can access health data by themselves

DEVICE

Garmin vivoactive 5 without self-monitoring data

Patients cannot access their health data

Locations (1)

Ramathibodi hospital, Mahidol university

Ratchathewi, Bangkok, Thailand