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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult; Adherence, Treatment; Positive Airway Pressure; Smart Watch
• Intervention / Treatment: Device: the smart watch and Samsung Health app

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart watch group; The user of the smart watch and Samsung Health app	Device: the smart watch and Samsung Health app; 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
No Intervention: Usual care; No use of both the smart watch and Samsung Health app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily usage of PAP (all days)	Average daily usage of PAP (all days) in 90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily usage of PAP (days used)	Average daily usage of PAP (days used) in 90 days	90 days
Percentage of days using PAP	Percentage of days using PAP	90 days
Percentage of days using PAP ≥ 4 hours	Percentage of days using PAP ≥ 4 hours	90 days
Percentage of patients meeting the National Health Insurance Service adherence criteria	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	90 days
Changes of the scores of Epworth Sleepiness Scale	Changes of the scores of Epworth Sleepiness Scale	90 days
Patient satisfaction with PAP therapy	Patient satisfaction with PAP therapy	90 days
Changes of the scores of Pittsburgh Sleep Quality Index	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)	90 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jaeyoung Cho, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): April 14, 2025
• Study Completion (Actual): April 14, 2025

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 3, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Treatment Adherence and Compliance
• Other Study ID Numbers: 22070571340

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No