The Improving Sleep in African American Couples Study (ISAAC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CPAP Training and Education, Virtual Disease Support Group Sessions, Couple CPAP Training and Education, Couples Virtual OSA Support Group Sessions.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Improving Sleep in African American Couples (ISAAC) Study
Overview
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.
Detailed 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 partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.
Interventions
- Behavioral CPAP Training and Education
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting. - Behavioral Virtual 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. - Behavioral Couple CPAP Training and Education
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting. - Behavioral Couples 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. - Behavioral CPAP 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. - Behavioral Couples' Cognitive Behavioral Therapy
Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.
Primary outcome measures
- Mean Nightly CPAP Use at 1 Year [Time frame: From enrollment until 1 year.]
Secondary outcome measures (11)
- Mean Nightly CPAP Use [Time frame: From enrollment to 30 days, 90 days, and 6 months.]
- Patient and Bed Partner Quality of Sleep [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Patient and Bed Partner Quality of Sleep [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Patient and Bed Partner Quality of Sleep [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Patient and Bed Partner Quality of Sleep [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Patient and Bed Partner Quality of Sleep [Time frame: 6 months]
- Patient and Bed Partner Quality of Life [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Patient and Bed Partner Sleep Apnea Quality of Life [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Sleep Apnea Beliefs [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Sleep Apnea Knowledge [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
- Self-efficacy to Use CPAP [Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- The MetroHealth System — Cleveland
- University of Pittsburgh Medical Center — Pittsburgh
Identifiers
NCT: NCT07447284 · STUDY00000597 · R01HL169588