Daridorexant to prevent delirium after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled pilot trial of daridorexant 50 mg given each of the first three nights after surgical aortic valve replacement or coronary artery bypass grafting. Participants complete a baseline visit, receive daridorexant or placebo in the hospital, and are evaluated daily for delirium symptoms and sleep during the first three postoperative days. The protocol includes an optional wrist-worn sleep monitor to collect objective sleep data in the postoperative setting. The trial follows a prior feasibility effort and is intended to generate preliminary effect estimates to plan a larger phase 2b trial.

Why it matters

Who can join: the full rules

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 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

Where it's running

• University of Rochester Medical Center
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Mark Oldham, MD
• Email: mark_oldham@urmc.rochester.edu
• Phone: 585-275-3592

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.