[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627334":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":51,"centralContacts":56,"locations":62,"responsibleParty":97,"collaborators":100,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":30,"enrollmentInfo":117,"targetDuration":30,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":130,"whyStopped":30,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"MetroHealth Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Behavioral: CPAP Training and Education","Behavioral: Virtual Disease Support Group Sessions",{"label":16,"type":17,"description":18,"interventionNames":19},"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\n\n1. CPAP instruction from sleep technologist\n2. 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner\n3. Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes\n\n5\\. 5 cognitive behavioral couple therapy sessions",[20,21,22,23],"Behavioral: Couple CPAP Training and Education","Behavioral: Couples Virtual OSA Support Group Sessions","Behavioral: CPAP Tele-monitoring and Feedback","Behavioral: Couples' Cognitive Behavioral Therapy",[25,31,35,39,43,47],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","CPAP Training and Education","Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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.",[9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Couple CPAP Training and Education","Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.",[16],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"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.",[16],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"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.",[16],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Couples' Cognitive Behavioral Therapy","Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.",[16],[52],{"name":53,"affiliation":54,"role":55},"John Thornton, MD, MPH","MetroHealth System, Ohio","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":30,"email":61},"Marquisha Marbury","CONTACT","216-778-8484","mmarbury@metrohealth.org",[63,80],{"facility":64,"status":30,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"The MetroHealth System","Cleveland","Ohio","44109","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-81.69541,41.4995,{"lat":74,"lon":73},[77,79],{"name":58,"role":59,"phone":78,"phoneExt":30,"email":61},"2167788484",{"name":53,"role":55,"phone":30,"phoneExt":30,"email":30},{"facility":81,"status":30,"city":82,"state":83,"zip":84,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",{"type":71,"coordinates":86},[87,88],-79.99589,40.44062,{"lat":88,"lon":87},[91,95],{"name":92,"role":59,"phone":93,"phoneExt":30,"email":94},"Stuti Vaidya, MPH","4129006637","vaidyas@upmc.edu",{"name":96,"role":55,"phone":30,"phoneExt":30,"email":30},"Sanjay Patel, MD, MS",{"type":55,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Daryl Thornton, MD","Principal Investigator",[101,104,106],{"name":102,"class":103},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":105,"class":6},"University of Pittsburgh",{"name":54,"class":6},"100627334","the-improving-sleep-in-african-american-couples-study-isaac-100627334",false,"NCT07447284","The Improving Sleep in African American Couples Study (ISAAC)","The Improving Sleep in African American Couples (ISAAC) Study","ISAAC","Inclusion Criteria - Patient:\n\n* Moderate or severe OSA (Apnea hypopnea index ≥ 15 events\u002Fhour)\n* Age ≥ 30 years\n* Bed partner for ≥ last 6 months who is willing to participate\n* English proficient\n\nInclusion Criteria - Bed Partner\n\n* Bed partner for ≥ 6 months and willing to participate\n* English proficient\n\nExclusion Criteria - Patient:\n\n* Terminal illness\n* Neurocognitive disorder that prevents informed consent\n* Unstable housing\n* Need for other forms of positive airway pressure (BPAP or VPAP)\n* Pregnancy","ALL","30 Years",{"count":118,"type":119},440,"ESTIMATED","INTERVENTIONAL",[122],"NA","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.",[125],"Obstructive Sleep Apnea (OSA)",[127,128,129],"Sleep Apnea Syndromes\u002FTherapy","Continuous Positive Airway Pressure","Couples Therapy","NOT_YET_RECRUITING","2026-02-26",{"date":133,"type":134},"2026-03-03","ACTUAL",{"date":136,"type":119},"2026-03-01",{"date":138,"type":119},"2028-07",{"name":5,"class":6},2]