Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Study Overview
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Brief Summary
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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.

Official Title
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Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Motivational Enhancement Therapy
* Device: Positive Airway Pressure (PAP) therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Enhancement Therapy (MET)<br>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<br>* 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.<br>Device: Positive Airway Pressure (PAP) therapy<br>* Positive Airway Pressure (PAP) therapy will be administered as per standard of care.<br>|
| Active Comparator: PAP therapy<br>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<br>* Positive Airway Pressure (PAP) therapy will be administered as per standard of care.<br>|

What is the study measuring?
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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 |