Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PAP adherence (minutes)
研究概览
简要总结
The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio.
Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prescribed PAP therapy from the sleep center for > 1 week
- •Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for > 1 week
- •Non-adherent with PAP therapy
- •Willing to continue using current PAP device for 28 days continuously
- •Have an electronic device compatible with the wearable app
排除标准
- •Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
- •Use home oxygen
- •Unstable medical or psychiatric illness
- •Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
- •Planned surgery or hospitalization during study period
- •Planned extensive travel during study period
- •History of repeated non-attendance at clinic visits
研究组 & 干预措施
Immediate Intervention
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
干预措施: Immediate Intervention (Behavioral)
Waitlist control
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
干预措施: Waitlist control (Behavioral)
结局指标
主要结局
PAP adherence (minutes)
时间窗: 5 weeks
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).
Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3)
时间窗: 5 weeks
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization.
次要结局
- PAP adherence (percent of days used >= 4 hours)(5 weeks)
- Change in PAP Adherence (Days Used >= 4 Hours) From Baseline to Post-treatment (T3)(5 weeks)
研究者
Constance Fung
Principal Investigator
VA Greater Los Angeles Healthcare System