Obstructive Sleep Apnea (OSA)ISAACNCT07447284
The Improving Sleep in African American Couples Study (ISAAC)
A study testing CPAP Training and Education, Virtual Disease Support Group Sessions and Couple CPAP Training and Education in people with Obstructive Sleep Apnea (OSA), run by MetroHealth Medical Center at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP Training and Education, Virtual Disease Support Group Sessions and Couple CPAP Training and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Bed partner for ≥ 6 months and willing to participate
- English proficient
Who cannot join
- Terminal illness
- Neurocognitive disorder that prevents informed consent
- Unstable housing
- Need for other forms of positive airway pressure (BPAP or VPAP)
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The MetroHealth System
Cleveland, Ohio, 44109
Marquisha Marbury, 2167788484, mmarbury@metrohealth.org
John Thornton, MD, MPH
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Stuti Vaidya, MPH, 4129006637, vaidyas@upmc.edu
Sanjay Patel, MD, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- 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
- Keywords
- Sleep Apnea Syndromes/Therapy, Continuous Positive Airway Pressure, Couples Therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP Training and EducationBehavioural
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
Virtual Disease Support Group SessionsBehavioural
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 EducationBehavioural
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
Couples Virtual OSA Support Group SessionsBehavioural
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 FeedbackBehavioural
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 TherapyBehavioural
Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual. Receives: Behavioral: CPAP Training and Education; Behavioral: Virtual Disease Support Group Sessions |
| Couple-oriented Intervention Arm | Active comparator | 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 Receives: Behavioral: Couple CPAP Training and Education; Behavioral: Couples Virtual OSA Support Group Sessions; Behavioral: CPAP Tele-monitoring and Feedback; Behavioral: Couples' Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until 1 year.
Secondary outcomes (11)
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.
Measured: From enrollment to 30 days, 90 days, and 6 months.
Patient and Bed Partner Quality of Sleep
Epworth Sleepiness Scale
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
PROMIS Sleep Disturbance Index
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
PROMIS Sleep-Related Impairment
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
Functional Outcomes of Sleep short version
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Patient and Bed Partner Quality of Sleep
Actigraphy Data
Measured: 6 months
Patient-Reported Measure of OSA Treatment
Patient-Reported Longitudinal Assessment Tool for OSA (PLATO-11)
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year
Patient and Bed Partner Quality of Life
General quality of life will be assessed using the SF-12
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep Apnea Beliefs
Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale.
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep Apnea Knowledge
Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Self-efficacy to Use CPAP
Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA).
Measured: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CPAP telemonitoring and feedback Behavioral couple therapy Couple peer motivators
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, MetroHealth System, Ohio
- Responsible party
- Principal investigator, Daryl Thornton, MD, MetroHealth Medical Center
- Investigators
- John Thornton, MD, MPH, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447284
- Sponsor's protocol ID
- STUDY00000597
- Other IDs
- R01HL169588
- Acronym
- ISAAC
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving Sleep in African American Couples (ISAAC) Study
- ClinicalTrials.gov ID
- NCT07447284
- Acronym / sponsor ID
- ISAAC / STUDY00000597
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Sleep Apnea Syndromes/Therapy, Continuous Positive Airway Pressure, Couples Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh, MetroHealth System, Ohio
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- CPAP telemonitoring and feedback Behavioral couple therapy Couple peer motivators
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: CPAP Training and Education, Behavioral: Virtual Disease Support Group SessionsPatients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual. |
| Couple-oriented Intervention Arm | Active comparator | Behavioral: Couple CPAP Training and Education, Behavioral: Couples Virtual OSA Support Group Sessions, Behavioral: CPAP Tele-monitoring and Feedback, Behavioral: Couples' Cognitive Behavioral TherapyPatients 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Bed partner for ≥ 6 months and willing to participate
Key exclusion criteria (5 listed)
- Terminal illness
- Neurocognitive disorder that prevents informed consent
- Unstable housing
- Need for other forms of positive airway pressure (BPAP or VPAP)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP Training and EducationSleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting. | Behavioural | Usual Care |
| Virtual Disease Support Group SessionsPatients 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. | Behavioural | Usual Care |
| Couple CPAP Training and EducationSleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting. | Behavioural | Couple-oriented Intervention Arm |
| Couples Virtual OSA Support Group SessionsPatient 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. | Behavioural | Couple-oriented Intervention Arm |
| CPAP Tele-monitoring and FeedbackPatients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use. | Behavioural | Couple-oriented Intervention Arm |
| Couples' Cognitive Behavioral TherapyFive cognitive behavioral couple therapy sessions will be provided to patients and their bed partners. | Behavioural | Couple-oriented Intervention Arm |
Primary outcome
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.
11 secondary outcomes
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-Reported Measure of OSA Treatment
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year
Patient and Bed Partner 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. Study data will be de-identified according to HIPAA and the Common Rule. It will subsequently be available through NHLBI BioData Catalyst.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Thornton, MD, MPH principal investigator
MetroHealth System, Ohio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP Training and Education, Virtual Disease Support Group Sessions and Couple CPAP Training and Education in people with Obstructive Sleep Apnea (OSA), run by MetroHealth Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marquisha Marbury (216-778-8484, mmarbury@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Nightly CPAP Use at 1 Year (time frame: From enrollment until 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.