The Improving Sleep in African American Couples Study (ISAAC) (ISAAC)

August 25, 2026 updated by: Daryl Thornton, MD, MetroHealth Medical Center

The Improving Sleep in African American Couples (ISAAC) Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • The MetroHealth System
        • Contact:
        • Principal Investigator:
          • John Thornton, MD, MPH
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Sanjay Patel, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Usual Care
Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
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.
Active Comparator: Couple-oriented Intervention Arm

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment until 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
Epworth Sleepiness Scale
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.
PROMIS Sleep Disturbance Index
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.
PROMIS Sleep-Related Impairment
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.
Functional Outcomes of Sleep short version
From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
Time Frame: 6 months
Actigraphy Data
6 months
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
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 will be assessed using the Apnea Beliefs Scale.
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.
Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.
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.
Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA).
From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient-Reported Measure of OSA Treatment
Time Frame: From enrollment to 30 days, 90 days, 6 months, and 1 year
Patient-Reported Longitudinal Assessment Tool for OSA (PLATO-11)
From enrollment to 30 days, 90 days, 6 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MetroHealth Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
MetroHealth System, Ohio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Thornton, MD, MPH, MetroHealth System, Ohio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000597
  • R01HL169588 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.

IPD Sharing Time Frame

Data will be available from 1 to 4 years after the conclusion of the study.

IPD Sharing Access Criteria

Those with access to NHLBI BioData Catalyst will have access to study data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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