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

Key facts

Who runs it
Ramathibodi Hospital
Where
Thailand1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
80 people, planned
Started
6 Jan 2026
Planned end
30 Jun 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • garmin vivoactive 5 with self-monitoring data
  • Garmin vivoactive 5 without self-monitoring data
Record updated
30 January 2026

Who can take part

Age
19 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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 take part

  • Patients had been previously used CPAP for treatment of OSA
  • Patients had active cardiovascular, pulmonary, psychiatric disease, and epilepsy
  • Patients deny to provide an informed consent
  • Patients have a problem to use a wearable device or watch
  • Patients had used any smartwatch before
  • Patients do not have a smart phone

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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?

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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

The 2 groups in the trial

  • Wearable groupTreatment being tested

    Standard care of CPAP with Garmin vivoactive 5 with self-monitoring data (Patients can access the data by themselves)

    Treatment: garmin vivoactive 5 with self-monitoring data

  • Control groupSham treatment, for comparison

    Standard care of CPAP with Garmin vivoactive 5 no self-monitoring data (Patients cannot access the data by themselves)

    Treatment: Garmin vivoactive 5 without self-monitoring data

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Wearable Device to Promote CPAP Adherence in Patients With Obstructive Sleep Apnea (OSA); A Randomized Controlled Trial
Record updated
30 January 2026