Clinical trial NCT05530265: Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)
Official title: Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Positive Airway Pressure
Adherence, Treatment
Smart Watch
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 92
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average daily usage of PAP (all days)
timeFrame: 90 days
Secondary outcomes:
measure: Average daily usage of PAP (days used)
timeFrame: 90 days
measure: Percentage of days using PAP
timeFrame: 90 days
measure: Percentage of days using PAP ≥ 4 hours
timeFrame: 90 days
measure: Percentage of patients meeting the National Health Insurance Service adherence criteria
timeFrame: 90 days
measure: Changes of the scores of Epworth Sleepiness Scale
timeFrame: 90 days
measure: Changes of the scores of Pittsburgh Sleep Quality Index
timeFrame: 90 days
measure: Patient satisfaction with PAP therapy
timeFrame: 90 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jaeyoung Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: