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Daridorexant to Prevent Post-cardiotomy Delirium

RecruitingPhase 2Ages 60 Years - anyAllUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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. Participants 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ 60 yrs; * having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital; * can provide consent; * able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English); * family member or close friend for collateral. Exclusion Criteria: * Prior cardiotomy * Infectious endocarditis * Emergency surgery * Delirium at baseline (positive 3D-CAM) * Auditory or visual impairment that prevents study procedures * Alcohol or substance misuse (CAGE-AID score โ‰ฅ 2) * Psychotic disorder * Dementia-level deficits (TICS \< 27) * Use of a prescription sleep aid at least every other night * Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole) * Daridorexant intolerance * Severe kidney or liver impairment (Child-Pugh โ‰ฅ7, Cockcroft-Gault \<30 mL/min, or on dialysis) * Narcolepsy * Suicidal ideation at baseline * Any condition that, in the PI's opinion, compromises patient safety or data quality * 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
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What it tests

  • Daridorexant 50 mg
  • Placebo
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Where

1 site
University of Rochester Medical Center
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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