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

University of Miami

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Motivational Enhancement Therapy; Device: Positive Airway Pressure (PAP) therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06047353

P50MD017347 (U.S. NIH Grant/Contract)

20211138

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Motivational Enhancement Therapy (MET)

Experimental group

Description:

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

Treatment:

Device: Positive Airway Pressure (PAP) therapy

Behavioral: Motivational Enhancement Therapy

PAP therapy

Active Comparator group

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.

Treatment:

Device: Positive Airway Pressure (PAP) therapy