Actively Recruiting
An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
Led by Mayo Clinic · Updated on 2025-12-30
40
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
A
Arizona State University (ASU)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a smartphone application called SleepWell24 to help people with obstructive sleep apnea (OSA) use their continuous positive airway pressure (CPAP) devices for at least 6 hours a night, 6 nights a week. The study aims to improve long-term CPAP adherence and quality of life by offering a precision medicine approach that monitors and supports treatment use. Adults newly diagnosed with OSA who are prescribed CPAP and able to use smartphones are invited to participate. Participants will use the SleepWell24 app alongside a Shelly smart plug and a Fitbit Charge 4 wearable device to track CPAP usage, physical activity, sleep time, and sedentary behavior. The study includes an initial 8-week group of 20 participants, followed by a 6-month group with another set of 20 participants. Weekly questionnaires will also be completed to support monitoring and engagement. During the study, participants will have their CPAP adoption and changes in quality of life assessed at baseline and weekly for approximately 6 months. Additional measures include changes in sleep time, physical activity, and sedentary time tracked with the wearable device and app. The study will observe participants' adherence and lifestyle changes to better understand how the app supports CPAP treatment over time.
CONDITIONS
Brief Title
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Newly diagnosed with obstructive sleep apnea confirmed by clinical sleep testing
- Able to speak and read English
- Own and can use an Apple (iOS 9 or higher) or Android (4.2 or higher) smartphone with little or no assistance
- Prescribed continuous or auto-titrated CPAP therapy
- Agree to use a smartphone application and wearable wrist sensor
You will not qualify if you...
- Unwilling to complete study measures or use the SleepWell24 app
- Refuse to use the Fitbit application during the trial
- Have communication, cognitive, acute, severe health, or psychological conditions limiting participation
- Currently involved in other lifestyle programs or research studies
- Plan to use a PAP device other than ResMed Airsense 10
- Prescribed high-dose benzodiazepines (more than 1 mg lorazepam per night)
- Use daily opioid medication at night
- Unwilling to stop using any current wearable sensor during the trial
- Have a history of treatment or referral for claustrophobia
- Previous CPAP use
- Currently working night shifts or rotating day and night shifts
- Currently pregnant, trying to conceive, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks or up to 6 months depending on cohort
Participants use the SleepWell24 application along with connected devices to monitor CPAP usage and complete weekly questionnaires.
Weekly visits or assessments for up to 6 months
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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