An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- CPAP Adoption
研究概览
简要总结
The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.
- •In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
- •Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who:
- •Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study;
- •Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance;
- •Are prescribed continuous or auto-titrated CPAP;
- •Agree to using a smartphone application and wearable wrist sensor; and
- •Speak and read English.
排除标准
- •Unwilling to complete study measures and engage with SleepWell24;
- •Refuse to not use the Fitbit application during the study trial;
- •Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions);
- •Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.);
- •Decide to use a different PAP device than ResMed Airsense 10;
- •Prescribed high-dose benzodiazepines (equivalent to > 1 mg lorazapam/night);
- •Daily opioid medication use at night;'
- •Unwilling to discontinue use of any current wearable sensor for the duration of the trial;
- •Previous documented history of treatment/referral for claustrophobia;
- •Previous CPAP use;
- •Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and
- •Currently pregnant, trying to conceive, or breastfeeding.
研究组 & 干预措施
SleepWell24 Smart Application
This group will consists of participates who will be on study for 8 weeks using the Sleepwell24 application. Once 20 people are enrolled on the 8 week cohort, a 6 month cohort will open up for 20 different participants.
干预措施: SleepWell24 Application (Behavioral)
结局指标
主要结局
CPAP Adoption
时间窗: approximately 6 months
The Shelly smart plug will be used to monitor the amount of CPAP time usage by the amount of wattage recorded.
Change in Quality of Life
时间窗: baseline, weekly assessments for approximately 6 months
As measured by weekly survey asking participants to rate their health based on excellent, very good, good, fair, and poor.
次要结局
- Change in sleep time(baseline, weekly assessments for approximately 6 months)
- Change in physical activity(baseline, weekly assessments for approximately 6 months)
- Change in sedentary time(baseline, weekly assessments for approximately 6 months)
研究者
Timothy Morgenthaler
Principal Investigator
Mayo Clinic