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Completed

NCT Number: NCT05530265

Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)

Continuous positive airway pressure (CPAP) is highly effective in treating obstructive sleep apnea (OSA). However, this treatment modality relies heavily on patient adherence, and poor adherence to the treatment limits its effectiveness in treating OSA. Strategies to augment adherence are needed in the management of OSA.

The smart watch and linked app provide various health information, including sleep, snoring or oxygen saturation during sleep, exercise, blood pressure, and electrocardiogram. The smart watch and linked app could potentially improve adherence to positive airway pressure (PAP) treatment.

This randomized controlled trial (RCT) aimed to examine whether the use of smart watch and app can increase PAP adherence in patients with OSA.

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Key information

Conditions

Obstructive Sleep Apnea of Adult Adherence, Treatment Behavior Health Behavior Positive Airway Pressure Smart Watch Treatment Adherence and Compliance

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with OSA (apnea-hyponea index [AHI])≥ 5 /h) by type 1 polysomnography
  • no prior use of PAP (CPAP or auto-adjusting PAP [APAP]), or no prior use of PAP within the previous 90 days in patients who had received PAP therapy, or current PAP users with average daily usage (all days) < 4 hours within the previous 90 days

Exclusion criteria

  • patients who refuse PAP therapy
  • patients who have used a smart watch (e.g., Galaxy Watch, Apple Watch, etc.) within the previous 90 days
  • patients with central sleep apnea or neuromuscular disease
  • patients receiving supplemental oxygen therapy due to underlying diseases including heart failure, stroke, chronic obstructive pulmonary disease, interstitial pulmonary disease, hypoventilation syndrome, or whose baseline oxygen saturation is less than 90%
  • patients with implanted cardiac pacemakers, defibrillators, or other electronic devices
  • patients who are inexperienced in using smartphones, apps, or smart watches
  • patients with an inability or unwillingness to provide informed consent

Treatment and study plan

the smart watch and Samsung Health app

Device

Use the smart watch (Galaxy Watch 4, Samsung Electronics Co., Ltd., Korea) and the Samsung Health app (Samsung Electronics Co., Ltd., Korea) for 90 days of positive airway pressure treatment

Primary outcomes

  1. Average daily usage of PAP (all days)

    Time frame: 90 days

    Average daily usage of PAP (all days) in 90 days

Secondary outcomes

  1. Average daily usage of PAP (days used)

    Time frame: 90 days

    Average daily usage of PAP (days used) in 90 days

  2. Percentage of days using PAP

    Time frame: 90 days

    Percentage of days using PAP

  3. Percentage of days using PAP ≥ 4 hours

    Time frame: 90 days

    Percentage of days using PAP ≥ 4 hours

  4. Percentage of patients meeting the National Health Insurance Service adherence criteria

    Time frame: 90 days

    The National Health Insurance Service adherence criteria: ≥ 4 hours of use on ≥ 70% of days over 30 consecutive days during the 90 days of PAP therapy

  5. Changes of the scores of Epworth Sleepiness Scale

    Time frame: 90 days

    Changes of the scores of Epworth Sleepiness Scale

  6. Changes of the scores of Pittsburgh Sleep Quality Index

    Time frame: 90 days

    Changes of the scores of Pittsburgh Sleep Quality Index (an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality)

  7. Patient satisfaction with PAP therapy

    Time frame: 90 days

    Patient satisfaction with PAP therapy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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