Obstructive Sleep Apnea
Conditions
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.
Interventions
BEHAVIORALMotivational 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.
Positive Airway Pressure (PAP) therapy will be administered as per standard of care.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hours patient adhered to PAP therapy | 3 months | Measured in the number of hours of use of PAP therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactNaresh Punjabi, MD
Backup ContactNaresh Punjabi
Outcome results
None listed