[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07447284":3,"trial-entities:NCT07447284":162,"trial-summary:NCT07447284":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":59,"secondary_outcomes":64,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":101,"eligibility_criteria":102,"std_ages":116,"locations":119,"central_contacts":154,"overall_officials":157,"references":160,"see_also_links":161},"NCT07447284","STUDY00000597","The Improving Sleep in African American Couples Study (ISAAC)","The Improving Sleep in African American Couples (ISAAC) Study","RECRUITING","2028-07","2026-08","2026-08-27","2026-07-24","MetroHealth Medical Center","OTHER",true,"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.","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.",[19],"Obstructive Sleep Apnea (OSA)",[21,22,23],"Sleep Apnea Syndromes\u002FTherapy","Continuous Positive Airway Pressure","Couples Therapy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},440,"ESTIMATED",[32,38,42,47,51,55],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","CPAP Training and Education","Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.",[37],"Usual Care",{"type":33,"name":39,"description":40,"armGroupLabels":41},"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.",[37],{"type":33,"name":43,"description":44,"armGroupLabels":45},"Couple CPAP Training and Education","Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.",[46],"Couple-oriented Intervention Arm",{"type":33,"name":48,"description":49,"armGroupLabels":50},"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.",[46],{"type":33,"name":52,"description":53,"armGroupLabels":54},"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.",[46],{"type":33,"name":56,"description":57,"armGroupLabels":58},"Couples' Cognitive Behavioral Therapy","Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.",[46],[60],{"measure":61,"description":62,"timeFrame":63},"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.","From enrollment until 1 year.",[65,69,73,75,77,79,82,86,89,92,95],{"measure":66,"description":67,"timeFrame":68},"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.","From enrollment to 30 days, 90 days, and 6 months.",{"measure":70,"description":71,"timeFrame":72},"Patient and Bed Partner Quality of Sleep","Epworth Sleepiness Scale","From enrollment to 30 days, 90 days, 6 months, and 1 year.",{"measure":70,"description":74,"timeFrame":72},"PROMIS Sleep Disturbance Index",{"measure":70,"description":76,"timeFrame":72},"PROMIS Sleep-Related Impairment",{"measure":70,"description":78,"timeFrame":72},"Functional Outcomes of Sleep short version",{"measure":70,"description":80,"timeFrame":81},"Actigraphy Data","6 months",{"measure":83,"description":84,"timeFrame":85},"Patient-Reported Measure of OSA Treatment","Patient-Reported Longitudinal Assessment Tool for OSA (PLATO-11)","From enrollment to 30 days, 90 days, 6 months, and 1 year",{"measure":87,"description":88,"timeFrame":72},"Patient and Bed Partner Quality of Life","General quality of life will be assessed using the SF-12",{"measure":90,"description":91,"timeFrame":72},"Sleep Apnea Beliefs","Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale.",{"measure":93,"description":94,"timeFrame":72},"Sleep Apnea Knowledge","Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.",{"measure":96,"description":97,"timeFrame":72},"Self-efficacy to Use CPAP","Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA).","ALL","30 Years",null,false,{"inclusion":103,"exclusion":109,"raw_text":115},[104,105,106,107,108,107],"Moderate or severe OSA (Apnea hypopnea index ≥ 15 events\u002Fhour)","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",[110,111,112,113,114],"Terminal illness","Neurocognitive disorder that prevents informed consent","Unstable housing","Need for other forms of positive airway pressure (BPAP or VPAP)","Pregnancy","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",[117,118],"ADULT","OLDER_ADULT",[120,138],{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":135},"The MetroHealth System","Cleveland","Ohio","44109","United States",[127,132],{"name":128,"role":129,"phone":130,"email":131},"Marquisha Marbury","CONTACT","2167788484","mmarbury@metrohealth.org",{"name":133,"role":134},"John Thornton, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":136,"lon":137},41.4995,-81.69541,{"facility":139,"status":140,"city":141,"state":142,"zip":143,"country":125,"contacts":144,"geoPoint":151},"University of Pittsburgh Medical Center","NOT_YET_RECRUITING","Pittsburgh","Pennsylvania","15213",[145,149],{"name":146,"role":129,"phone":147,"email":148},"Stuti Vaidya, MPH","4129006637","vaidyas@upmc.edu",{"name":150,"role":134},"Sanjay Patel, MD, MS",{"lat":152,"lon":153},40.44062,-79.99589,[155],{"name":128,"role":129,"phone":156,"email":131},"216-778-8484",[158],{"name":133,"affiliation":159,"role":134},"MetroHealth System, Ohio",[],[],{"nct_id":4,"conditions":163,"biomarkers":165},[164],"Obstructive Sleep Apnea",[],{"nct_id":4,"found":15,"summary":167,"prompt_version":177},{"design":168,"status":169,"heading":170,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This is a randomized study involving 220 African American patients with moderate to severe OSA and their bed partners. Participants will be assigned by chance to either receive standard CPAP care or a couple-oriented intervention.","completed","Improving Sleep in African American Couples Study (ISAAC) for Obstructive Sleep Apnea","The ISAAC study is looking for African American couples where one partner has moderate to severe obstructive sleep apnea (OSA). This study aims to see if a special program, including CPAP training for couples, virtual support groups led by other couples with OSA, and CPAP tele-monitoring with feedback, can help people use their CPAP machine more consistently. Another group will receive standard CPAP training. The main goal is to measure how much CPAP is used nightly after one year. You may be able to join if you are at least 30 years old, have moderate or severe OSA, and have a bed partner who has lived with you for at least six months and is willing to participate. The study is currently recruiting 440 participants.","Participants' nightly CPAP use will be measured from enrollment until one year.",125,"Participants will receive CPAP training and education, attend virtual support group sessions, and may participate in virtual cognitive behavioral couple therapy sessions. CPAP use will be monitored for one year.","Not stated in the trial record.",[],"v2"]