Obstructive Sleep ApneaNCT06381115
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life
A study testing SleepWell24 Application in people with Obstructive Sleep Apnea, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SleepWell24 Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Rebecca K Ra, 507-284-2122, ra.rebecca@mayo.edu
Timothy Morgenthaler, MD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Betty Monari, 480-574-2641, Monari.Betty@mayo.edu
Umesh Goswami, MD
About this study
Official title: An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SleepWell24 Application
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepWell24 ApplicationBehavioural
The SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage.
| Study group | Role | What they receive |
|---|---|---|
| SleepWell24 Smart Application | Experimental | 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. Receives: Behavioral: SleepWell24 Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adoption
The Shelly smart plug will be used to monitor the amount of CPAP time usage by the amount of wattage recorded.
Measured: approximately 6 months
Change in Quality of Life
As measured by weekly survey asking participants to rate their health based on excellent, very good, good, fair, and poor.
Measured: baseline, weekly assessments for approximately 6 months
Secondary outcomes (3)
Change in sleep time
As measured by the Fitbit Charge 4 sensor, reported in hours
Measured: baseline, weekly assessments for approximately 6 months
Change in physical activity
As measured by the Fitbit Charge 4 sensor step count, reported as number of steps taken daily
Measured: baseline, weekly assessments for approximately 6 months
Change in sedentary time
As measured by the Fitbit Charge 4 sensor, reported in hours
Measured: baseline, weekly assessments for approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Timothy Morgenthaler, Mayo Clinic
- Investigators
- Timothy Morgenthaler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381115
- Sponsor's protocol ID
- 23-006685
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An App-Based, Precision Medicine Approach to Optimize Long-Term CPAP Adherence and Quality of Life
- ClinicalTrials.gov ID
- NCT06381115
- Acronym / sponsor ID
- 23-006685
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SleepWell24 Smart Application | Experimental | Behavioral: SleepWell24 ApplicationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleepWell24 ApplicationThe SleepWell24 application will use connections with a Shelly smart plug and a Fitbit Charge 4 along with weekly questionnaires to monitor CPAP usage. | Behavioural | SleepWell24 Smart Application |
Primary outcome
CPAP Adoption
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in sleep time
Time frame: baseline, weekly assessments for approximately 6 months
Change in physical activity
Time frame: baseline, weekly assessments for approximately 6 months
Change in sedentary time
Time frame: baseline, weekly assessments for approximately 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Morgenthaler, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepWell24 Application in people with Obstructive Sleep Apnea, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Adoption (time frame: approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.