Obstructive Sleep ApneaNCT05343000
Lifestyle Program for Obstructive Sleep Apnea With Severe Obesity
A study testing Home-based pulmonary rehabilitation (PR) system in people with Obstructive Sleep Apnea and Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- Home-based pulmonary rehabilitation (PR) system
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients, 18 years of age or older.
- Diagnosis of Obstructive Sleep Apnea (OSA) and obesity (BMI > or = to 35).
Who cannot join
- Individuals < 18 years of age.
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity
The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- Home-based pulmonary rehabilitation (PR) system
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitation (PR) systemBehavioural
Technology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals.
| Study group | Role | What they receive |
|---|---|---|
| Severe Comorbid OSA | Experimental | Newly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system Receives: Behavioral: Home-based pulmonary rehabilitation (PR) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Use the Devices at Home
The number of participants who were able to utilize the devices at home.
Measured: 2 Weeks
Usability of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome.
Measured: 2 Weeks
Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome.
Measured: 2 Weeks
Secondary outcomes (2)
Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their confidence in using the proposed system greater than a 6 on a 10-point scale. The scale ranged from 1=not confident to 10=very confident, with higher scores indicating greater confidence.
Measured: 2 Weeks
Perceived Benefit of Proposed System in Patients With OSA and Obesity
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. The number of participants who rated their perceived benefit from the system greater than a 7 on a 10-point scale. The scale ranged from 1=not beneficial to 10=very beneficial, with higher scores indicating greater benefit.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start3 Feb 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Minnesota HealthSolutions
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto Benzo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343000
- Sponsor's protocol ID
- 21-011497
- Other IDs
- R43HL162131
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2022
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea With Severe Obesity
- ClinicalTrials.gov ID
- NCT05343000
- Acronym / sponsor ID
- 21-011497
- Conditions
- Obstructive Sleep Apnea, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Minnesota HealthSolutions
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 16 Oct 2025
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 develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Severe Comorbid OSA | Experimental | Behavioral: Home-based pulmonary rehabilitation (PR) systemNewly-diagnosed severe comorbid obstructive sleep apnea subjects will use technology to facilitate remote health coaching through a home-based pulmonary rehabilitation (PR) system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients, 18 years of age or older.
- Diagnosis of Obstructive Sleep Apnea (OSA) and obesity (BMI > or = to 35).
Key exclusion criteria (2 listed)
- Individuals < 18 years of age.
- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
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 |
|---|---|---|
| Home-based pulmonary rehabilitation (PR) systemTechnology to facilitate remote health coaching through PAP management, sleep scheduling, sleep duration, diet, exercise, medication and more. The tablet and sensors upload the patient's activities, physiological data, and answers to the daily self-report questions to a secure website. This website also allows health coaches to view patient data via overview, weekly, daily, and trend reports. Health coaches call patients regularly to celebrate progress, assist with any issues, and set new goals. | Behavioural | Severe Comorbid OSA |
Primary outcome
Ability to Use the Devices at Home
Time frame: 2 Weeks
The number of participants who were able to utilize the devices at home.
Usability of Proposed System in Patients With OSA and Obesity
Time frame: 2 Weeks
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the ease of using the technology on a scale of 1 to 10 (1=very difficult, 10=very easy), with higher scores indicating a better outcome.
Helpfulness of Set-up Instructions of Proposed System in Patients With OSA and Obesity
Time frame: 2 Weeks
Patients were interviewed by the study coordinator following completion of the intervention. Participants provided feedback on the acceptability and usability of the system, including what they liked and did not like about the interface, the concept of a home-based system, and the health coaching. Participants rated the helpfulness of the setup instructions from 1 to 10 (1=not at all helpful, 10=very helpful), with lower scores indicating a worse outcome.
2 secondary outcomes
Participant Reported Confidence Using Proposed System in Patients With OSA and Obesity
Time frame: 2 Weeks
Perceived Benefit of Proposed System in Patients With OSA and Obesity
Time frame: 2 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Roberto Benzo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based pulmonary rehabilitation (PR) system in people with Obstructive Sleep Apnea and Obesity, run by Mayo Clinic at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to Use the Devices at Home (time frame: 2 Weeks). The study lists 3 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 16 Oct 2025.