Effect of Smart Watch and App on Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Average daily usage of PAP (all days)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Smart watch group
The user of the smart watch and Samsung Health app
干预措施: the smart watch and Samsung Health app (Device)
Usual care
No use of both the smart watch and Samsung Health app
结局指标
主要结局
Average daily usage of PAP (all days)
时间窗: 90 days
Average daily usage of PAP (all days) in 90 days
次要结局
- Percentage of days using PAP ≥ 4 hours(90 days)
- Patient satisfaction with PAP therapy(90 days)
- Percentage of days using PAP(90 days)
- Average daily usage of PAP (days used)(90 days)
- Changes of the scores of Pittsburgh Sleep Quality Index(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)
研究者
Jaeyoung Cho
Associate Professor
Seoul National University Hospital