NCT05530265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

September 3, 2022

Last Update Submit

April 21, 2026

Conditions

Smart WatchObstructive Sleep Apnea of AdultPositive Airway PressureAdherence, Treatment

Outcome Measures

Primary Outcomes (1)

  • Average daily usage of PAP (all days)

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

    90 days

Secondary Outcomes (7)

  • Average daily usage of PAP (days used)

    90 days

  • Percentage of days using PAP

    90 days

  • Percentage of days using PAP ≥ 4 hours

    90 days

  • Percentage of patients meeting the National Health Insurance Service adherence criteria

    90 days

  • Changes of the scores of Epworth Sleepiness Scale

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Smart watch group

EXPERIMENTAL

The user of the smart watch and Samsung Health app

Device: the smart watch and Samsung Health app

Usual care

NO INTERVENTION

No use of both the smart watch and Samsung Health app

Interventions

the smart watch and Samsung Health appDEVICE

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

Smart watch group

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Jaeyoung Cho, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 7, 2022

Study Start

August 22, 2022

Primary Completion

April 14, 2025

Study Completion

April 14, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

KR(1)