App-Based Optimization of Long-Term CPAP Adherence and Quality of Life (NCT06381115) | Clinical Trial Compass
RecruitingNot Applicable
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
United States40 participantsStarted 2025-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 medic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CPAP Adoption
Timeframe: approximately 6 months
2
Change in Quality of Life
Timeframe: baseline, weekly assessments for approximately 6 months