An interventional study of garmin vivoactive 5 with self-monitoring data and Garmin vivoactive 5 without self-monitoring data in Obstructive Sleep Apnea (OSA), sponsored by Ramathibodi Hospital. Not yet recruiting at 1 site in Thailand. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Supportive care
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
Follow-Up Procedures 4.1 Week 1 and 2 (Line call/video call Follow-Up) All participants will be contacted by Line call/video call at Week 1 and 2 to assess CPAP adherence, address difficulties, and provide additional guidance to promote usage of at least 4 hours per night. Participants in the wearable group will be asked to capture screenshots from their Garmin Connect app and send them via the Sleep Center's official LINE account. The data collected will include sleep stage distribution, total sleep time, heart rate, oxygen saturation, sleep score, and step count.
4.2 Weeks 4 and 8 (Clinic Follow-Up) At Weeks 4 and 8, participants will attend in-person follow-up visits at the Sleep Clinic.
Data collected will include:
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care of CPAP with Garmin vivoactive 5 with self-monitoring data (Patients can access the data by themselves)
Device: garmin vivoactive 5 with self-monitoring data
Standard care of CPAP with Garmin vivoactive 5 no self-monitoring data (Patients cannot access the data by themselves)
Device: Garmin vivoactive 5 without self-monitoring data
patients can access health data by themselves
Patients cannot access their health data
Average daily CPAP usage time
Average CPAP usage time per day, measured in minutes using CPAP device data.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
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.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
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.
Time frame: From enrollment to 4 week and 8 week of treament
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.
Time frame: From enrollment to 4 week and 8 week of treatment
Total sleep time
Total sleep time measured in minutes, derived from Garmin Vivoactive 5 and CPAP data
Time frame: From enrollment to 4 week and 8 week of treatment
Percentage of light sleep stage derived from wearable device
Percentage of light sleep stage (%), derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Percentage of deep sleep stage derived from wearable device
Percentage of deep sleep stage (%), derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Percentage of REM sleep stage derived from wearable device
Percentage of REM sleep stage (%), derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Mean heart rate derived from wearable device
Average heart rate measured in beats per minute (bpm), derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Average oxygen saturation derived from wearable device
Average oxygen saturation measured as a percentage (%), derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Stress score derived from wearable device
Stress score reported by Garmin Vivoactive 5, ranging from 0 to 100.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Sleep score derived from wearable device
Sleep score reported by Garmin Vivoactive 5, ranging from 0 to 100.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Daily step count derived from wearable device
Average daily step count measured in steps per day, derived from Garmin Vivoactive 5.
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Ramathibodi Hospital