Community Health Advocates for Motivating PAP Use in Our Neighborhoods. (Champion)

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Motivational Enhancement Therapy; Device: Positive Airway Pressure (PAP) therapy

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naresh Punjabi, MD; Phone Number: 305-243-6388; Email: npunjabi@miami.edu
• Study Contact Backup: Name: Naresh Punjabi; Phone Number: 3052436388; Email: npunjabi@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Naresh M Punjabi, MD
      • Principal Investigator: Naresh M Punjabi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.; Device: Positive Airway Pressure (PAP) therapy; Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
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.	Device: Positive Airway Pressure (PAP) therapy; Positive Airway Pressure (PAP) therapy will be administered as per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hours patient adhered to PAP therapy	Measured in the number of hours of use of PAP therapy	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Naresh Punjabi, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 20211138; P50MD017347 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes