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

NCT07377968 | Not Yet Recruiting DMC

• 1 other identifier: COA. No. MURA2025/1065
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

adherence; OSA; wearable device; health

Outcome Measures

Primary Outcomes (2)

• Average daily CPAP usage time

  Average CPAP usage time per day, measured in minutes using CPAP device data.

  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.

  From enrollment to 4 weeks and 8 weeks of treatment

Secondary Outcomes (11)

• Daytime sleepiness assessed by Epworth Sleepiness Scale (Thai version)

  From enrollment to 4 week and 8 week of treament

• Sleep quality assessed by Pittsburgh Sleep Quality Index (Thai version)

  From enrollment to 4 week and 8 week of treatment

• Total sleep time

  From enrollment to 4 week and 8 week of treatment

• Percentage of light sleep stage derived from wearable device

  From enrollment to 4 weeks and 8 weeks of treatment

• Percentage of deep sleep stage derived from wearable device

  From enrollment to 4 weeks and 8 weeks of treatment

Study Arms (2)

Wearable group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

garmin vivoactive 5 with self-monitoring data DEVICE

patients can access health data by themselves

Wearable group

Garmin vivoactive 5 without self-monitoring data DEVICE

Patients cannot access their health data

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Ramathibodi hospital, Mahidol university

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (5)

• 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.

  PMID: 32130137 BACKGROUND

• Weaver 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.

  PMID: 18250209 BACKGROUND

• Luyster 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.

  PMID: 22654183 BACKGROUND

• Schyvens 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.

  PMID: 40303381 BACKGROUND

• Fox 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.

  PMID: 22467985 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Visasiri Tantrakul, Doctor of Medicine (M.D.)

  Ramathibodi hospital, Mahidol university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Visasiri Tantrakul, Doctor of Medicine (M.D.)

CONTACT

(660)86-379-3629; Vtantrakul@gmail.com

Somruetai Matupumanon, Doctor of Medicine (M.D.)

CONTACT

(660)889644536; many_toon@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 30, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

TH (1)