[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645057":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":129,"collaborators":133,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":42,"enrollmentInfo":153,"targetDuration":42,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":167,"whyStopped":42,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Positive airway pressure (PAP) therapy","ACTIVE_COMPARATOR","Participants will use a PAP machine to treat their obstructive sleep apnea.",[13],"Device: Positive airway pressure (PAP) therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Dental device","Participants will use a sleep dental device to treat their obstructive sleep apnea.",[18],"Device: Sleep dental device",{"label":20,"type":10,"description":21,"interventionNames":22},"Medications - atomoxetine-oxybutynin","Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.",[23],"Drug: Atomoxetine-oxybutynin",[25,31,37],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.",[9],[30],"CPAP",{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Sleep dental device","An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.",[15],[36],"Mandibular advancement device (MAD)",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Atomoxetine-oxybutynin","The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.",[20],null,[44],{"name":45,"affiliation":5,"role":46},"Sairam Parthasarathy, MD","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":42,"email":52},"Heidi Erickson, BSN, RN","CONTACT","1-520-626-5287","herickso@arizona.edu",[54,78,91,110],{"facility":55,"status":42,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Banner University Medical Center Tucson","Tucson","Arizona","85719","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-110.92648,32.22174,{"lat":65,"lon":64},[68,72,75,77],{"name":69,"role":50,"phone":70,"phoneExt":42,"email":71},"Nayeli Lopez","1-520-626-6453","nayelij@arizona.edu",{"name":73,"role":74,"phone":42,"phoneExt":42,"email":42},"Saif Mashaqi, MD","SUB_INVESTIGATOR",{"name":76,"role":74,"phone":42,"phoneExt":42,"email":42},"Monisha Das Ireland, MD",{"name":45,"role":46,"phone":42,"phoneExt":42,"email":42},{"facility":79,"status":42,"city":80,"state":81,"zip":82,"country":59,"countryCode":60,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Stanford Medical Center","Palo Alto","California","94305",{"type":62,"coordinates":84},[85,86],-122.14302,37.44188,{"lat":86,"lon":85},[89],{"name":90,"role":46,"phone":42,"phoneExt":42,"email":42},"Clete Kushida, MD, PhD",{"facility":92,"status":42,"city":93,"state":94,"zip":95,"country":59,"countryCode":60,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University of Miami Miller School of Medicine","Miami","Florida","33136",{"type":62,"coordinates":97},[98,99],-80.19366,25.77427,{"lat":99,"lon":98},[102,106,108],{"name":103,"role":50,"phone":104,"phoneExt":42,"email":105},"Nina L'Houtellier","1-305-689-1358","nvl15@med.miami.edu",{"name":107,"role":46,"phone":42,"phoneExt":42,"email":42},"Girardin Jean-Louis, PhD",{"name":109,"role":74,"phone":42,"phoneExt":42,"email":42},"Alexandre Abreu, MD",{"facility":111,"status":42,"city":112,"state":113,"zip":114,"country":59,"countryCode":60,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Maryland Medical Center","Baltimore","Maryland","21201",{"type":62,"coordinates":116},[117,118],-76.61219,39.29038,{"lat":118,"lon":117},[121,125,127],{"name":122,"role":50,"phone":123,"phoneExt":42,"email":124},"Christine Johnston","1-410-706-7853","christine.johnston@som.umaryland.edu",{"name":126,"role":46,"phone":42,"phoneExt":42,"email":42},"Emerson Wickwire, PhD",{"name":128,"role":74,"phone":42,"phoneExt":42,"email":42},"Danielle Glick, MD",{"type":130,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Sairam Parthasarathy","Principal Investigator, Professor of Medicine",[134,136,137,139,141],{"name":135,"class":6},"Patient-Centered Outcomes Research Institute",{"name":5,"class":6},{"name":138,"class":6},"University of Maryland",{"name":140,"class":6},"University of Miami",{"name":142,"class":6},"Stanford University","100645057","phase-4-a-comparative-effectiveness-study-of-positive-airway-pressure-pap-therapy-dental-device-and-atomoxetine-oxybutynin-for-treatment-of-obstructive-sleep-apnea-in-adults-100645057",false,"NCT07679282","A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults","Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study","ADAPT-OSA","Inclusion Criteria:\n\n* Obstructive sleep apnea (AHI \\>\u002F= 5 per hour), diagnosed in the past 6 months\n* Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness\n* Willingness\u002Fability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)\n* Health insurance of any type\n\nExclusion Criteria:\n\n* Prior treatment for OSA in past year\n* Central sleep apnea or narcolepsy\n* Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)\n* Heart failure with reduced ejection fraction of \\\u003C\u002F= 45%\n* Active coronary artery disease (angina or infarction within 3 months of enrollment)\n* Current untreated depression\n* Untreated narrow angle glaucoma\n* Untreated hypothyroidism\n* Clinically significant gastric retention\n* Clinically significant urinary retention\n* History of liver disease\n* Seizure disorder\n* Pregnant or nursing, or plans to become pregnant within the year\n* Concomitant medication use that is incompatible with atomoxetine or oxybutynin\n* Participation in another clinical study with an investigational product","ALL","18 Years",{"count":154,"type":155},2400,"ESTIMATED","INTERVENTIONAL",[158],"PHASE4","Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.",[161],"Obstructive Sleep Apnea (OSA)",[163,164,165,39,166],"Sleep apnea treatments","Dental device for sleep","Positive airway pressure","Comparative effectiveness","NOT_YET_RECRUITING","2026-06-29",{"date":170,"type":171},"2026-07-01","ACTUAL",{"date":173,"type":155},"2026-09-01",{"date":175,"type":155},"2032-05-01",{"name":131,"class":6},4]