The Improving Sleep in African American Couples Study (ISAAC)
ConditionObstructive Sleep Apnea (OSA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorMetroHealth Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Terminal illness
Neurocognitive disorder that prevents informed consent
Unstable housing
Need for other forms of positive airway pressure (BPAP or VPAP)
Trial design
Treatments tested in this trial
- 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
Treatment groups
440 Participants
are divided into 2 treatment groupsSponsors and collaborators
MetroHealth Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pittsburgh
Collaborator
MetroHealth System, Ohio
Collaborator
Source ClinicalTrials.gov