Obstructive Sleep ApneaChampionNCT06047353
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
A study testing Motivational Enhancement Therapy and Positive Airway Pressure (PAP) therapy in people with Obstructive Sleep Apnea, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Motivational Enhancement Therapy and Positive Airway Pressure (PAP) therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 31 Dec 2027
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Moderate-to-severe OSA
- Available to attend study visits and sessions
- Reliable access to a phone
Who cannot join
- Prior or current use of PAP therapy or other treatment (e.g., oral appliance) for OSA
- History of upper airway surgery for OSA
- Moderate to severe insomnia
- Commercial drivers
- Use of non-standard PAP including adaptive servo-ventilation or bi-level positive airway pressure
- Report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
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- Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
- Other sleep disorders (e.g., circadian rhythm disorder)
- Use of supplemental oxygen during wakefulness or sleep
- Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep apnea test
- Resting awake oxygen saturation (SpO2) < 90%
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Naresh M Punjabi, MD
Naresh M Punjabi, MD
About this study
The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Motivational Enhancement Therapy, Positive Airway Pressure (PAP) therapy
- 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.
Motivational Enhancement TherapyBehavioural
Motivational Enhancement Therapy (MET) is based on the principles of motivational interviewing and is designed to promote self-efficacy and maximize behavioral change. MET will be given via phone and/or in person (approximately 30 minutes) at baseline, week 1, week 2, week 4, and week 8.
Positive Airway Pressure (PAP) therapyDevice
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Enhancement Therapy (MET) | Experimental | Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months. Receives: Behavioral: Motivational Enhancement Therapy; Device: Positive Airway Pressure (PAP) therapy |
| PAP therapy | Active comparator | Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months. Receives: Device: Positive Airway Pressure (PAP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hours patient adhered to PAP therapy
Measured in the number of hours of use of PAP therapy
Measured: 3 months
Secondary outcomes (3)
Blood pressure
Clinic blood pressure measured in mmHg
Measured: 3 months
Mean Glucose Level
Mean glucose from continuous glucose monitoring measured in mg/dl
Measured: 3 months
Epworth Sleepiness Scale Score
Mean Epworth Sleepiness Score (minimum 1; maximum 24) with higher scores indicating increased sleepiness.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Sep 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 University of MiamiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Naresh Punjabi, University of Miami
- Investigators
- Naresh Punjabi, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047353
- Sponsor's protocol ID
- 20211138
- Other IDs
- P50MD017347
- Acronym
- Champion
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
- ClinicalTrials.gov ID
- NCT06047353
- Acronym / sponsor ID
- Champion / 20211138
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (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 research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement Therapy (MET) | Experimental | Behavioral: Motivational Enhancement Therapy, Device: Positive Airway Pressure (PAP) therapyParticipants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months. |
| PAP therapy | Active comparator | Device: Positive Airway Pressure (PAP) therapyParticipants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Moderate-to-severe OSA
- Available to attend study visits and sessions
- Reliable access to a phone
Key exclusion criteria (12 listed)
- Prior or current use of PAP therapy or other treatment (e.g., oral appliance) for OSA
- History of upper airway surgery for OSA
- Moderate to severe insomnia
- Commercial drivers
- Use of non-standard PAP including adaptive servo-ventilation or bi-level positive airway pressure
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 |
|---|---|---|
| Motivational Enhancement TherapyMotivational Enhancement Therapy (MET) is based on the principles of motivational interviewing and is designed to promote self-efficacy and maximize behavioral change. MET will be given via phone and/or in person (approximately 30 minutes) at baseline, week 1, week 2, week 4, and week 8. | Behavioural | Motivational Enhancement Therapy (MET) |
| Positive Airway Pressure (PAP) therapyPositive Airway Pressure (PAP) therapy will be administered as per standard of care. | Device | Motivational Enhancement Therapy (MET), PAP therapy |
Primary outcome
Number of hours patient adhered to PAP therapy
Time frame: 3 months
Measured in the number of hours of use of PAP therapy
3 secondary outcomes
Blood pressure
Time frame: 3 months
Mean Glucose Level
Time frame: 3 months
Epworth Sleepiness Scale Score
Time frame: 3 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 23 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Naresh Punjabi principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Enhancement Therapy and Positive Airway Pressure (PAP) therapy in people with Obstructive Sleep Apnea, run by University of Miami 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 4 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 23 Dec 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?
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?
Contact Naresh Punjabi, MD (305-243-6388, npunjabi@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hours patient adhered to PAP therapy (time frame: 3 months). 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 23 Dec 2025.