Using community health advocates to improve PAP therapy adherence for sleep apnea.
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
NA · University of Miami · NCT06047353
This study is testing whether support from community health workers can help people with sleep apnea stick to their PAP therapy better than regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06047353 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of motivational enhancement therapy (MET) delivered by culturally congruent community health care workers (CHWs) compared to standard care for patients with untreated moderate-to-severe obstructive sleep apnea (OSA). The study will focus on improving adherence to positive airway pressure (PAP) therapy among participants. By leveraging community health advocates, the study seeks to address barriers to treatment and enhance patient motivation and engagement. Participants will be monitored for their adherence to PAP therapy over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have moderate-to-severe obstructive sleep apnea and have not previously used PAP therapy.
Not a fit: Patients who have prior experience with PAP therapy or other treatments for obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve adherence to PAP therapy, leading to better health outcomes for patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promise in using community health workers to improve health outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Naresh Punjabi — University of Miami
- Study coordinator: Naresh Punjabi, MD
- Email: npunjabi@miami.edu
- Phone: 305-243-6388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea