Daridorexant to Prevent Post-cardiotomy Delirium
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
University of Rochester
80 participants
Oct 14, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- ≥ 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 Criteria16
- 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 ≥ 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 ≥7, 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
Interventions
Administered consistent with labeling from the US Food and Drug Administration.
Identical appearing to daridorexant
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07217912