Health TrialsbyHealthPanel

The Improving Sleep in African American Couples Study (ISAAC)

ConditionObstructive Sleep Apnea (OSA)
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Usual CarePlacebo comparator 2 interventions
Group B: Couple-oriented Intervention ArmActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Mean Nightly CPAP Use at 1 Year

Mean CPAP use at year will be the total hours of CPAP use divided by the number of days observed for the patient over the course of a year.

Time frame
From enrollment until 1 year.

Secondary outcomes

1

Mean Nightly CPAP Use

Mean CPAP use will be the total hours of CPAP use divided by the number of days observed for the patient over the course of the designated time interval.

Time frame
From enrollment to 30 days, 90 days, and 6 months.
2

Patient and Bed Partner Quality of Sleep

Epworth Sleepiness Scale

Time frame
From enrollment to 30 days, 90 days, 6 months, and 1 year.
3

Patient and Bed Partner Quality of Sleep

PROMIS Sleep Disturbance Index

Time frame
From enrollment to 30 days, 90 days, 6 months, and 1 year.
4

Patient and Bed Partner Quality of Sleep

PROMIS Sleep-Related Impairment

Time frame
From enrollment to 30 days, 90 days, 6 months, and 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MetroHealth Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Pittsburgh

Collaborator

MetroHealth System, Ohio

Collaborator

Source ClinicalTrials.gov
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