Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06047353

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Motivational Enhancement Therapy

Positive Airway Pressure (PAP) therapy

Study Details

Brief 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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06047353

Start date

Sep 29, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Motivational Enhancement Therapy (MET)

Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.

active comparator: PAP therapy

Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.

Interventions

Motivational Enhancement Therapy

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

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

Primary outcome measure

  • Number of hours patient adhered to PAP therapy [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Naresh Punjabi, MD

305-243-6388npunjabi@miami.edu

Naresh Punjabi

3052436388npunjabi@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Naresh M Punjabi, MD

More Information

Sponsor

University of Miami

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-12-23.