NCT06047353

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Sep 2023Dec 2027

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4.2 years

First QC Date

September 14, 2023

Last Update Submit

December 19, 2025

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Number of hours patient adhered to PAP therapy

    Measured in the number of hours of use of PAP therapy

    3 months

Secondary Outcomes (3)

  • Blood pressure

    3 months

  • Mean Glucose Level

    3 months

  • Epworth Sleepiness Scale Score

    3 months

Study Arms (2)

Motivational Enhancement Therapy (MET)

EXPERIMENTAL

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

Behavioral: Motivational Enhancement TherapyDevice: Positive Airway Pressure (PAP) therapy

PAP therapy

ACTIVE COMPARATOR

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

Device: Positive Airway Pressure (PAP) therapy

Interventions

Motivational Enhancement TherapyBEHAVIORAL

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.

Motivational Enhancement Therapy (MET)
Positive Airway Pressure (PAP) therapyDEVICE

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

Motivational Enhancement Therapy (MET)PAP therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Moderate-to-severe OSA
  • Available to attend study visits and sessions
  • Reliable access to a phone

You may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Motivational InterviewingTherapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Naresh Punjabi

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naresh Punjabi, MD

CONTACT

305-243-6388npunjabi@miami.edu

Naresh Punjabi

CONTACT

3052436388npunjabi@miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)