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New app aims to boost CPAP use for sleep apnea sufferers

NCT ID NCT06381115

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This Mayo Clinic study tests a smartphone app called SleepWell24 to help people with obstructive sleep apnea use their CPAP machine for at least 6 hours a night, 6 nights a week. The app connects to a smart plug and a Fitbit to track CPAP usage, sleep time, and activity. Researchers will enroll 40 adults newly diagnosed with sleep apnea to see if the app improves CPAP adherence and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SleepWell24 smartphone app
What this could lead to
If successful, this app could help people with sleep apnea stick with CPAP therapy, leading to better sleep and quality of life.
What could go wrong
This is a small, early-stage study with only 40 participants. The app may not work for everyone, and results may not apply to all CPAP users.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.