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

Primary Purpose

Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Positive Airway Pressure (PAP) therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Enhancement Therapy (MET)

PAP therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of hours patient adhered to PAP therapy
Measured in the number of hours of use of PAP therapy

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06047353
Brief Title
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
Acronym
Champion
Official Title
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Enhancement Therapy (MET)
Arm Type
Experimental
Arm Description
Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
Arm Title
PAP therapy
Arm Type
Active Comparator
Arm Description
Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure (PAP) therapy
Intervention Description
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
Primary Outcome Measure Information:
Title
Number of hours patient adhered to PAP therapy
Description
Measured in the number of hours of use of PAP therapy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Clinic blood pressure measured in mmHg
Time Frame
3 months
Title
Mean Glucose Level
Description
Mean glucose from continuous glucose monitoring measured in mg/dl
Time Frame
3 months
Title
Epworth Sleepiness Scale Score
Description
Mean Epworth Sleepiness Score (minimum 1; maximum 24) with higher scores indicating increased sleepiness.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naresh Punjabi, MD
Phone
305-243-6388
Email
npunjabi@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Naresh Punjabi
Phone
3052436388
Email
npunjabi@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naresh Punjabi
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naresh M Punjabi, MD
First Name & Middle Initial & Last Name & Degree
Naresh M Punjabi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

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