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

Not Applicable

Recruiting

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

• Registration Number: NCT05530265
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-03
• Study First Posted: 2022-09-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart watch group	the smart watch and Samsung Health app	The user of the smart watch and Samsung Health app

Primary Outcome Measures

Name	Time	Method
Average daily usage of PAP (all days)	90 days	Average daily usage of PAP (all days) in 90 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of