The Improving Sleep in African American Couples Study (ISAAC)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT07447284
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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

Primary Outcome Measure

Mean Nightly CPAP Use at 1 Year [ Time Frame: From enrollment until 1 year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The MetroHealth SystemClevelandOhio44109
Marquisha Marbury
[email protected]
2167788484
John Thornton, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Stuti Vaidya, MPH
[email protected]
4129006637
Sanjay Patel, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
The MetroHealth System· Cleveland, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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