Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
NCT ID: NCT06047353
Last Updated: 2025-12-23
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
48 participants
INTERVENTIONAL
2023-09-29
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Motivational Enhancement Therapy (MET)
Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
Motivational Enhancement Therapy
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) therapy
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
PAP therapy
Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.
Positive Airway Pressure (PAP) therapy
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
Interventions
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Motivational Enhancement Therapy
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) therapy
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
Eligibility Criteria
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Inclusion Criteria
* Moderate-to-severe OSA
* Available to attend study visits and sessions
* Reliable access to a phone
Exclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Miami
OTHER
Responsible Party
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Naresh Punjabi
Professor
Principal Investigators
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Naresh Punjabi
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Naresh M Punjabi, MD
Role: primary
Other Identifiers
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20211138
Identifier Type: -
Identifier Source: org_study_id