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Purpose

The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.

Condition

Eligibility

Eligible Ages
Over 30 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient: - Moderate or severe OSA (Apnea hypopnea index ≥ 15 events/hour) - Age ≥ 30 years - Bed partner for ≥ last 6 months who is willing to participate - English proficient Inclusion Criteria - Bed Partner - Bed partner for ≥ 6 months and willing to participate - English proficient

Exclusion Criteria

  • Patient: - Terminal illness - Neurocognitive disorder that prevents informed consent - Unstable housing - Need for other forms of positive airway pressure (BPAP or VPAP) - Pregnancy

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
CPAP telemonitoring and feedback Behavioral couple therapy Couple peer motivators
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Usual Care 		Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
  • Behavioral: CPAP Training and Education
    Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
  • Behavioral: Virtual Disease Support Group Sessions
    Patients will attend 3 virtual webinars on prevention and management of diseases affecting the Black community including hypertension, obesity, cardiovascular disease, and cancer led by African American providers.
Active Comparator
Couple-oriented Intervention Arm 		Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following 1. CPAP instruction from sleep technologist 2. 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner 3. Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes 5. 5 cognitive behavioral couple therapy sessions
  • Behavioral: Couple CPAP Training and Education
    Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
  • Behavioral: Couples Virtual OSA Support Group Sessions
    Patient and their bed partner will participate in 3 virtual group sessions moderated by an African American patient with longstanding OSA who regularly uses CPAP and their bed partner.
  • Behavioral: CPAP Tele-monitoring and Feedback
    Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
  • Behavioral: Couples' Cognitive Behavioral Therapy
    Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.

Recruiting Locations

The MetroHealth System
Cleveland, Ohio 44109
Contact:
Marquisha Marbury
2167788484
mmarbury@metrohealth.org

More Details

Status
Recruiting
Sponsor
MetroHealth Medical Center

Study Contact

Marquisha Marbury
216-778-8484
mmarbury@metrohealth.org

Detailed Description

This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.