What this study is
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.
What's being tested
- Motivational Enhancement Therapy
Intervention · BEHAVIORAL
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
Intervention · DEVICE
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
Study details
- Sponsor
- University of Miami
- Conditions
- Obstructive Sleep Apnea
- Enrolling
- 48 people
- Starts
- 2023-09-29
- Est. completion
- 2027-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 18 years of age
- Moderate-to-severe OSA
- Available to attend study visits and sessions
- Reliable access to a phone
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Miami
Miami, Florida, United States
- Naresh M Punjabi, MD · Contact
- Naresh M Punjabi, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Miami
Study ID 20211138
Principal investigator
Naresh Punjabi
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.