Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Last updated: January 31, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Motivational Enhancement Therapy

Positive Airway Pressure (PAP) therapy

Clinical Study ID

NCT06047353
20211138
P50MD017347
  • Ages 18-100
  • All Genders

Study 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 previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.

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

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Motivational Enhancement Therapy
Phase:
Study Start date:
September 29, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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