About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥ 19 yr of age) with moderate to severe OSA (AHI ≥ 15 events/hr at the sleep clinic in Ramathibodi hospital
Study after EC approval to March, 2026
Patients with OSA who are prescribed CPAP therapy and accepted a trial of therapy
Disqualifiers
Patients deny to provide an informed consent
Patients had active cardiovascular, pulmonary, psychiatric disease, and epilepsy
Patients had been previously used CPAP for treatment of OSA
Patients have a problem to use a wearable device or watch
Trial design
Parallel
Treatments tested in this trial
garmin vivoactive 5 with self-monitoring data
Devicepatients can access health data by themselves
Garmin vivoactive 5 without self-monitoring data
DevicePatients cannot access their health data
Treatment groups
Trial outcomes
Primary outcomes
Average daily CPAP usage time
Average CPAP usage time per day, measured in minutes using CPAP device data.
Percentage of nights with CPAP usage ≥ 4 hours
Percentage of days with CPAP usage ≥ 4 hours per night, reported as a percentage (%), derived from CPAP device data.
Secondary outcomes
Daytime sleepiness assessed by Epworth Sleepiness Scale (Thai version)
Epworth Sleepiness Scale (ESS) total score ranging from 0 to 24; higher scores indicate greater daytime sleepiness. A score \>10 indicates excessive daytime sleepiness.
Sleep quality assessed by Pittsburgh Sleep Quality Index (Thai version)
Pittsburgh Sleep Quality Index (PSQI) total score ranging from 0 to 21; higher scores indicate poorer sleep quality. A score \>5 indicates poor sleep quality.
Total sleep time
Total sleep time measured in minutes, derived from Garmin Vivoactive 5 and CPAP data
Percentage of light sleep stage derived from wearable device
Percentage of light sleep stage (%), derived from Garmin Vivoactive 5.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: