The Improving Sleep in African American Couples (ISAAC) Study
MetroHealth Medical Center
Summary
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.
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…
Eligibility
- Age range
- 30+ years
- Sex
- All
- 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
Interventions
- BehavioralCPAP Training and Education
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
- BehavioralVirtual 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.
- BehavioralCouple CPAP Training and Education
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
- BehavioralCouples 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.
- BehavioralCPAP 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.
Locations (2)
- The MetroHealth SystemCleveland, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania