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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smart Watch, Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Adherence, Treatment

Intervention / Treatment
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* Device: the smart watch and Samsung Health app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart watch group<br>The user of the smart watch and Samsung Health app | Device: the smart watch and Samsung Health app<br>* 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<br>|
| No Intervention: Usual care<br>No use of both the smart watch and Samsung Health app | |

What is the study measuring?
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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 | 
| 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 | 
| Patient satisfaction with PAP therapy | Patient satisfaction with PAP therapy | 90 days |