University of Rochester
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 hospital each of the first three nights after surgery.
Inclusion Criteria: * ≥ 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 sco…
Administered consistent with labeling from the US Food and Drug Administration.
Identical appearing to daridorexant
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