NCT06047353 · University of Miami
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
(Champion)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations