Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Obstructive Sleep Apnea Clinical Trial

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Official title:

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047353
• Other study ID #: 20211138
• Secondary ID: P50MD017347
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Naresh Punjabi, MD
• Phone: 305-243-6388
• Email: npunjabi[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hours patient adhered to PAP therapy	Measured in the number of hours of use of PAP therapy	3 months
Secondary	Blood pressure	Clinic blood pressure measured in mmHg	3 months
Secondary	Mean Glucose Level	Mean glucose from continuous glucose monitoring measured in mg/dl	3 months
Secondary	Epworth Sleepiness Scale Score	Mean Epworth Sleepiness Score (minimum 1; maximum 24) with higher scores indicating increased sleepiness.	3 months