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

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06047353

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

Enrollment

Location

Arms

36.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Behavioral: Motivational Enhancement Therapy Device: Positive Airway Pressure (PAP) therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Anticipated Study Start Date :

Dec 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of hours patient adhered to PAP therapy [3 months]
Measured in the number of hours of use of PAP therapy

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

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

Investigators

Principal Investigator: Naresh Punjabi, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naresh Punjabi, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT06047353

Other Study ID Numbers:

20211138
P50MD017347

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Sep 21, 2023