Adherence, Treatment, Obstructive Sleep Apnea of Adult, Positive Airway Pressure, Smart Watch
Conditions
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.
Interventions
DEVICEthe 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
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily usage of PAP (all days) | 90 days | Average daily usage of PAP (all days) in 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average daily usage of PAP (days used) | 90 days | Average daily usage of PAP (days used) in 90 days |
| Percentage of days using PAP | 90 days | Percentage of days using PAP |
| Percentage of days using PAP ≥ 4 hours | 90 days | Percentage of days using PAP ≥ 4 hours |
| 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 |
| 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) |
| Patient satisfaction with PAP therapy | 90 days | Patient satisfaction with PAP therapy |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJaeyoung Cho, M.D., Ph.D.
Seoul National University Hospital
Outcome results
None listed