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NCT Number: NCT06047353

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Naresh M Punjabi, MD

CONTACT

Naresh M Punjabi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Enhancement Therapy

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

Device

Positive Airway Pressure (PAP) therapy will be administered as per standard of care.

Primary outcomes

  1. Number of hours patient adhered to PAP therapy

    Time frame: 3 months

    Measured in the number of hours of use of PAP therapy

Secondary outcomes

  1. Blood pressure

    Time frame: 3 months

    Clinic blood pressure measured in mmHg

  2. Mean Glucose Level

    Time frame: 3 months

    Mean glucose from continuous glucose monitoring measured in mg/dl

  3. Epworth Sleepiness Scale Score

    Time frame: 3 months

    Mean Epworth Sleepiness Score (minimum 1; maximum 24) with higher scores indicating increased sleepiness.

Study contacts

Contact information is provided by the study sponsor or research team.

Naresh Punjabi

CONTACT

[email protected]

3052436388

Naresh Punjabi, MD

CONTACT

[email protected]

305-243-6388

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: Champion

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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