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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530265
• Other study ID #: 22070571340
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Jaeyoung Cho, M.D., Ph.D.
• Phone: +82-2-2072-2503
• Email: apricot6[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment
• Obstructive Sleep Apnea of Adult
• Positive Airway Pressure
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily usage of PAP (all days)	Average daily usage of PAP (all days) in 90 days	90 days
Secondary	Average daily usage of PAP (days used)	Average daily usage of PAP (days used) in 90 days	90 days
Secondary	Percentage of days using PAP	Percentage of days using PAP	90 days
Secondary	Percentage of days using PAP = 4 hours	Percentage of days using PAP = 4 hours	90 days
Secondary	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
Secondary	Changes of the scores of Epworth Sleepiness Scale	Changes of the scores of Epworth Sleepiness Scale	90 days
Secondary	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
Secondary	Patient satisfaction with PAP therapy	Patient satisfaction with PAP therapy	90 days