Status:
RECRUITING
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- ≥ 18 years of age
- Moderate-to-severe OSA
- Available to attend study visits and sessions
- Reliable access to a phone
- Exclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06047353
Start Date
September 29 2023
End Date
December 31 2027
Last Update
December 23 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136