Obstructive Sleep Apnea (OSA)NCT07377968
Wearable Device to Promote CPAP Adherence in Obstructive Sleep Apnea (OSA) Patients
A study testing garmin vivoactive 5 with self-monitoring data and Garmin vivoactive 5 without self-monitoring data in people with Obstructive Sleep Apnea (OSA), run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- garmin vivoactive 5 with self-monitoring data and Garmin vivoactive 5 without self-monitoring data
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 6 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients had used any smartwatch before
- Patients do not have a smart phone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Ramathibodi hospital, Mahidol university
Ratchathewi, Bangkok, 10400
Visasiri Tantrakul, Doctor of Medicine (M.D.), (660)86-379-3629, Vtantrakul@gmail.com
Somruetai Matupumanon, Doctor of Medicine (M.D.), (660)889644536, many_toon@hotmail.com
About this study
Official title: Efficacy of Wearable Device to Promote CPAP Adherence in Patients With Obstructive Sleep Apnea (OSA); A Randomized Controlled 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
Read more
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
Read the detailed description
- Lead-in Period Patients who have been diagnosed with moderate to severe obstructive sleep apnea and are scheduled to receive continuous positive airway pressure (CPAP) therapy will be referred to the Sleep Clinic, 7th Floor, Phra Thep Building, Ramathibodi Hospital. At this clinic, the research team will provide detailed information about the study. If the patient agrees to participate, written informed consent will be obtained. Participants will then be randomly assigned into one of two groups - the wearable device group or the control group - using block randomization. The allocation sequence will be prepared by a statistician and sealed in opaque envelopes to maintain allocation concealment. During this period, while waiting for CPAP device delivery from the supplier, participants will be asked to wear a Garmin Vivoactive 5 smartwatch to collect baseline data. They will also complete standardized questionnaires in Thai: the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) to evaluate baseline sleepiness and sleep quality.
- Wearable Device Group (N = 40) Participants in this group will receive a Garmin Vivoactive 5 smartwatch and be instructed on its proper use. They will also learn how to access their health data via the Garmin Connect application, including sleep stages (light, deep, REM), heart rate, oxygen saturation, and daily step count. These data will be used to enhance patient engagement and support goal setting for personal health improvement. Participants will continue to receive standard education and counseling regarding CPAP use, with an emphasis on adherence and motivation to achieve optimal health outcomes.
- Control Group (N = 40) Participants in this group will also receive a Garmin Vivoactive 5 smartwatch but will be informed that access to health data through the application will only be available during follow-up visits at the hospital, including the final follow-up visit. Participants will not have direct access to the application, as login requires a password controlled by the research team. If a participant connects the device to another account, the research team will be able to detect it due to the creation of a new user profile, resulting in incomplete data continuity. Patients will be able to view limited on-screen information, such as average oxygen saturation, sleep score, and step count. The screen brightness will be adjusted to the lowest level to minimize light exposure during sleep. They will also receive standard CPAP education identical to the intervention group, encouraging consistent device use for optimal treatment benefits.
- 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:
- From Garmin Connect: sleep stage, total sleep time, HR, oxygen saturation, sleep score, step count.
- From CPAP device downloads: average usage time per day (minutes), % nights used >4h, AHI, leak, and pressure levels. At Week 8, participants will again complete ESS and PSQI (Thai versions) to evaluate post-intervention outcomes.
- Data Management and API Integration During the study, the research team will request access to Garmin Health API for raw data retrieval, which may be used for further research analysis or development of a web-based application for patient monitoring.
- Data Collection and Analysis All collected data will be compiled, cleaned, and analyzed according to the predefined statistical plan.
- End of Study Procedure At the end of the 8-week study period, participants will return the Garmin Vivoactive 5 smartwatch. The research team will verify data completeness, clean and reset the devices, and prepare them for use by subsequent participants.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- garmin vivoactive 5 with self-monitoring data, Garmin vivoactive 5 without self-monitoring data
- Keywords
- adherence, OSA, wearable device, health
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garmin vivoactive 5 with self-monitoring dataDevice
patients can access health data by themselves
Garmin vivoactive 5 without self-monitoring dataDevice
Patients cannot access their health data
| Study group | Role | What they receive |
|---|---|---|
| Wearable group | Experimental | Standard care of CPAP with Garmin vivoactive 5 with self-monitoring data (Patients can access the data by themselves) Receives: Device: garmin vivoactive 5 with self-monitoring data |
| Control group | Sham comparator | Standard care of CPAP with Garmin vivoactive 5 no self-monitoring data (Patients cannot access the data by themselves) Receives: Device: Garmin vivoactive 5 without self-monitoring data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily CPAP usage time
Average CPAP usage time per day, measured in minutes using CPAP device data.
Measured: 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.
Measured: From enrollment to 4 weeks and 8 weeks of treatment
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 4 weeks and 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start6 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visasiri Tantrakul, Ramathibodi Hospital
- Investigators
- Visasiri Tantrakul, Doctor of Medicine (M.D.), Principal investigator, Ramathibodi hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377968
- Sponsor's protocol ID
- COA. No. MURA2025/1065
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aardoom JJ, Loheide-Niesmann L, Ossebaard HC, Riper H. Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. J Med Internet Res. 2020 Feb 18;22(2):e16972. doi: 10.2196/16972.
PubMed 32130137Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
PubMed 18250209Luyster FS, Strollo PJ Jr, Zee PC, Walsh JK; Boards of Directors of the American Academy of Sleep Medicine and the Sleep Research Society. Sleep: a health imperative. Sleep. 2012 Jun 1;35(6):727-34. doi: 10.5665/sleep.1846.
PubMed 22654183Schyvens AM, Peters B, Van Oost NC, Aerts JM, Masci F, Neven A, Dirix H, Wets G, Ross V, Verbraecken J. A performance validation of six commercial wrist-worn wearable sleep-tracking devices for sleep stage scoring compared to polysomnography. Sleep Adv. 2025 Mar 22;6(2):zpaf021. doi: 10.1093/sleepadvances/zpaf021. eCollection 2025 Apr.
PubMed 40303381Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
PubMed 22467985
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wearable Device to Promote CPAP Adherence in Patients With Obstructive Sleep Apnea (OSA); A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07377968
- Acronym / sponsor ID
- COA. No. MURA2025/1065
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- adherence, OSA, wearable device, health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 6 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Lead-in Period Patients who have been diagnosed with moderate to severe obstructive sleep apnea and are scheduled to receive continuous positive airway pressure (CPAP) therapy will be referred to the Sleep Clinic, 7th Floor, Phra Thep Building, Ramathibodi Hospital. At this clinic, the research team will provide detailed information about the study. If the patient agrees to participate, written informed consent will be obtained. Participants will then be randomly assigned into one of two groups - the wearable device group or the control group - using block randomization. The allocation sequence will be prepared by a statistician and sealed in opaque envelopes to maintain allocation concealment. During this period, while waiting for CPAP device delivery from the supplier, participants will be asked to wear a Garmin Vivoactive 5 smartwatch to collect baseline data. They will also complete standardized questionnaires in Thai: the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) to evaluate baseline sleepiness and sleep quality.
- Wearable Device Group (N = 40) Participants in this group will receive a Garmin Vivoactive 5 smartwatch and be instructed on its proper use. They will also learn how to access their health data via the Garmin Connect application, including sleep stages (light, deep, REM), heart rate, oxygen saturation, and daily step count. These data will be used to enhance patient engagement and support goal setting for personal health improvement. Participants will continue to receive standard education and counseling regarding CPAP use, with an emphasis on adherence and motivation to achieve optimal health outcomes.
- Control Group (N = 40) Participants in this group will also receive a Garmin Vivoactive 5 smartwatch but will be informed that access to health data through the application will only be available during follow-up visits at the hospital, including the final follow-up visit. Participants will not have direct access to the application, as login requires a password controlled by the research team. If a participant connects the device to another account, the research team will be able to detect it due to the creation of a new user profile, resulting in incomplete data continuity. Patients will be able to view limited on-screen information, such as average oxygen saturation, sleep score, and step count. The screen brightness will be adjusted to the lowest level to minimize light exposure during sleep. They will also receive standard CPAP education identical to the intervention group, encouraging consistent device use for optimal treatment benefits.
- 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:
- From Garmin Connect: sleep stage, total sleep time, HR, oxygen saturation, sleep score, step count.
- From CPAP device downloads: average usage time per day (minutes), % nights used >4h, AHI, leak, and pressure levels. At Week 8, participants will again complete ESS and PSQI (Thai versions) to evaluate post-intervention outcomes.
- Data Management and API Integration During the study, the research team will request access to Garmin Health API for raw data retrieval, which may be used for further research analysis or development of a web-based application for patient monitoring.
- Data Collection and Analysis All collected data will be compiled, cleaned, and analyzed according to the predefined statistical plan.
- End of Study Procedure At the end of the 8-week study period, participants will return the Garmin Vivoactive 5 smartwatch. The research team will verify data completeness, clean and reset the devices, and prepare them for use by subsequent participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable group | Experimental | Device: garmin vivoactive 5 with self-monitoring dataStandard care of CPAP with Garmin vivoactive 5 with self-monitoring data (Patients can access the data by themselves) |
| Control group | Sham comparator | Device: Garmin vivoactive 5 without self-monitoring dataStandard care of CPAP with Garmin vivoactive 5 no self-monitoring data (Patients cannot access the data by themselves) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Patients had used any smartwatch before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| garmin vivoactive 5 with self-monitoring datapatients can access health data by themselves | Device | Wearable group |
| Garmin vivoactive 5 without self-monitoring dataPatients cannot access their health data | Device | Control group |
Primary outcome
Average daily CPAP usage time
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Average CPAP usage time per day, measured in minutes using CPAP device data.
Percentage of nights with CPAP usage ≥ 4 hours
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Percentage of days with CPAP usage ≥ 4 hours per night, reported as a percentage (%), derived from CPAP device data.
11 secondary outcomes
Daytime sleepiness assessed by Epworth Sleepiness Scale (Thai version)
Time frame: From enrollment to 4 week and 8 week of treament
Sleep quality assessed by Pittsburgh Sleep Quality Index (Thai version)
Time frame: From enrollment to 4 week and 8 week of treatment
Total sleep time
Time frame: From enrollment to 4 week and 8 week of treatment
Percentage of light sleep stage derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Percentage of deep sleep stage derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Percentage of REM sleep stage derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Mean heart rate derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Average oxygen saturation derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Stress score derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Sleep score derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Daily step count derived from wearable device
Time frame: From enrollment to 4 weeks and 8 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 32130137Aardoom JJ, Loheide-Niesmann L, Ossebaard HC, Riper H. Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. J Med Internet Res. 2020 Feb 18;22(2):e16972. doi: 10.2196/16972.
- Background: PubMed 18250209Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
- Background: PubMed 22654183Luyster FS, Strollo PJ Jr, Zee PC, Walsh JK; Boards of Directors of the American Academy of Sleep Medicine and the Sleep Research Society. Sleep: a health imperative. Sleep. 2012 Jun 1;35(6):727-34. doi: 10.5665/sleep.1846.
- Background: PubMed 40303381Schyvens AM, Peters B, Van Oost NC, Aerts JM, Masci F, Neven A, Dirix H, Wets G, Ross V, Verbraecken J. A performance validation of six commercial wrist-worn wearable sleep-tracking devices for sleep stage scoring compared to polysomnography. Sleep Adv. 2025 Mar 22;6(2):zpaf021. doi: 10.1093/sleepadvances/zpaf021. eCollection 2025 Apr.
- Background: PubMed 22467985Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Visasiri Tantrakul, Doctor of Medicine (M.D.) principal investigator
Ramathibodi hospital, Mahidol university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing garmin vivoactive 5 with self-monitoring data and Garmin vivoactive 5 without self-monitoring data in people with Obstructive Sleep Apnea (OSA), run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Visasiri Tantrakul, Doctor of Medicine (M.D.) ((660)86-379-3629, Vtantrakul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily CPAP usage time (time frame: From enrollment to 4 weeks and 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07377968, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.