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NCT Number: NCT07447284

The Improving Sleep in African American Couples Study (ISAAC)

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The MetroHealth System, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Nightly CPAP Use at 1 Year

    Time frame: From enrollment until 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.

Secondary outcomes

  1. Mean Nightly CPAP Use

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

    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.

  2. Patient and Bed Partner Quality of Sleep

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

    Epworth Sleepiness Scale

  3. Patient and Bed Partner Quality of Sleep

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

    PROMIS Sleep Disturbance Index

  4. Patient and Bed Partner Quality of Sleep

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

    PROMIS Sleep-Related Impairment

  5. Patient and Bed Partner Quality of Sleep

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

    Functional Outcomes of Sleep short version

  6. Patient and Bed Partner Quality of Sleep

    Time frame: 6 months

    Actigraphy Data

  7. Patient and Bed Partner Quality of Life

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

    General quality of life will be assessed using the SF-12

  8. 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-related quality of life will be assessed using the Calgary Sleep Apnea Quality of Life Index.

  9. Sleep Apnea Beliefs

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

    Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale.

  10. Sleep Apnea Knowledge

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

    Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.

  11. Self-efficacy to Use CPAP

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

    Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA).

Study contacts

Contact information is provided by the study sponsor or research team.

Marquisha Marbury

CONTACT

[email protected]

216-778-8484

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • MetroHealth System, Ohio
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Pittsburgh

Registry information

Official study title

The Improving Sleep in African American Couples (ISAAC) Study

Acronym: ISAAC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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