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The Improving Sleep in African American Couples Study (ISAAC)

Key facts

Who runs it
MetroHealth Medical Center
Where
Cleveland and Pittsburgh, United StatesSee the 2 sites
Trial code
Status
Recruiting
People taking part
440 people, planned
Started
24 Jul 2026
Expected to end
Jul 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CPAP Training and Education
  • Virtual Disease Support Group Sessions
  • Couple CPAP Training and Education
  • Couples Virtual OSA Support Group Sessions
  • CPAP Tele-monitoring and Feedback
  • Couples' Cognitive Behavioral Therapy
Record updated
27 August 2026

Who can take part

Age
30 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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
  • Bed partner for ≥ 6 months and willing to participate
  • English proficient

Who cannot take part

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

Where in United States

  • The MetroHealth SystemCleveland, United StatesContact: Marquisha MarburyTaking people
  • University of Pittsburgh Medical CenterPittsburgh, United StatesContact: Stuti Vaidya, MPHNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Usual CarePlacebo, for comparison

    Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.

    Treatment: CPAP Training and Education and Virtual Disease Support Group Sessions

  • Couple-oriented Intervention ArmExisting treatment, for comparison

    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

    Treatment: Couple CPAP Training and Education, Couples Virtual OSA Support Group Sessions, CPAP Tele-monitoring and Feedback, and Couples' Cognitive Behavioral Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Improving Sleep in African American Couples (ISAAC) Study
Record updated
27 August 2026