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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorRamathibodi Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • garmin vivoactive 5 with self-monitoring data

    Device

    patients can access health data by themselves

  • Garmin vivoactive 5 without self-monitoring data

    Device

    Patients cannot access their health data

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Wearable groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: