[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609694":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"daridorexant","EXPERIMENTAL","Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.",[13],"Drug: Daridorexant 50 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","Oral matching placebo each of the first three nights after heart surgery.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Daridorexant 50 mg","Administered consistent with labeling from the US Food and Drug Administration.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Identical appearing to daridorexant",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mark Oldham, MD","CONTACT","585-275-3592","mark_oldham@urmc.rochester.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Rochester Medical Center","RECRUITING","Rochester","New York","14642","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-77.61556,43.15478,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mark Oldham","Associate Professor of Psychiatry","100609694","phase-2-daridorexant-to-prevent-post-cardiotomy-delirium-100609694",false,"NCT07217912","Daridorexant to Prevent Post-cardiotomy Delirium","Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery","Inclusion Criteria:\n\n* ≥ 60 yrs;\n* having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;\n* can provide consent;\n* able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);\n* family member or close friend for collateral.\n\nExclusion Criteria:\n\n* Prior cardiotomy\n* Infectious endocarditis\n* Emergency surgery\n* Delirium at baseline (positive 3D-CAM)\n* Auditory or visual impairment that prevents study procedures\n* Alcohol or substance misuse (CAGE-AID score ≥ 2)\n* Psychotic disorder\n* Dementia-level deficits (TICS \\\u003C 27)\n* Use of a prescription sleep aid at least every other night\n* Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)\n* Daridorexant intolerance\n* Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \\\u003C30 mL\u002Fmin, or on dialysis)\n* Narcolepsy\n* Suicidal ideation at baseline\n* Any condition that, in the PI's opinion, compromises patient safety or data quality\n* Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery","ALL","60 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.\n\nParticipants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.",[75,76],"Postoperative Cognitive Decline","Postoperative Delirium",[78,79,80,81],"delirium","sleep","cognitive decline","Alzheimer disease and related dementias","2026-01-06",{"date":84,"type":85},"2026-01-07","ACTUAL",{"date":87,"type":85},"2025-10-14",{"date":89,"type":69},"2027-11-01",{"name":5,"class":6},1]