App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
NCT ID: NCT06381115
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-01
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
SleepWell24 Application
The SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage.
Interventions
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SleepWell24 Application
The SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage.
Eligibility Criteria
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Inclusion Criteria
* In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
* 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
* 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.
18 Years
ALL
No
Sponsors
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Arizona State University (ASU)
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
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Timothy Morgenthaler
Principal Investigator
Principal Investigators
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Timothy Morgenthaler, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Facility Contacts
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Betty Monari
Role: primary
Rebecca K Ra
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-006685
Identifier Type: -
Identifier Source: org_study_id