Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Motivational Enhancement Therapy; Device: Positive Airway Pressure (PAP) therapy

• Registration Number: NCT06047353
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-09-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Enhancement Therapy (MET)	Motivational Enhancement Therapy	Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
Motivational Enhancement Therapy (MET)	Positive Airway Pressure (PAP) therapy	Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
PAP therapy	Positive Airway Pressure (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.

Primary Outcome Measures

Name	Time	Method
Number of hours patient adhered to PAP therapy	3 months	Measured in the number of hours of use of PAP therapy

Secondary Outcome Measures

Name	Time	Method
Blood pressure	3 months	Clinic blood pressure measured in mmHg
Mean Glucose Level	3 months	Mean glucose from continuous glucose monitoring measured in mg/dl
Epworth Sleepiness Scale Score	3 months	Mean Epworth Sleepiness Score (minimum 1; maximum 24) with higher scores indicating increased sleepiness.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States