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RECRUITING Not applicable ClinicalTrials.gov

The Improving Sleep in African American Couples Study (ISAAC)

Sponsor: MetroHealth Medical Center • ClinicalTrials.gov ID: NCT07447284

Registry updated: 2026-08-27
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Description

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.

Interventions

  • CPAP Training and Education (Behavioral)
    Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
  • Virtual Disease Support Group Sessions (Behavioral)
    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.
  • Couple CPAP Training and Education (Behavioral)
    Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
  • Couples Virtual OSA Support Group Sessions (Behavioral)
    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.
  • CPAP Tele-monitoring and Feedback (Behavioral)
    Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
  • Couples' Cognitive Behavioral Therapy (Behavioral)
    Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.

Eligibility criteria

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

Conditions

Obstructive Sleep Apnea (OSA)

Locations

  • The MetroHealth System — Cleveland, Ohio, United States
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record