Actively Recruiting
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Led by University of Rochester · Updated on 2026-01-07
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a pilot randomized clinical trial to gather preliminary data on the use of daridorexant for preventing delirium after heart surgery, specifically focusing on patients aged 60 and older undergoing aortic valve or coronary artery bypass graft surgery. This study builds on prior feasibility work and aims to assess daridorexant's impact on reducing delirium symptoms and incidence, improving sleep quality, and evaluating the practicality of collecting objective sleep data postoperatively. Participants will be randomly assigned to receive either oral daridorexant at 50 mg (or 25 mg if taking certain medications) or a matching placebo each night for the first three nights following heart surgery. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. There is also an option for participants to wear a sleep monitor during these nights to collect additional sleep quality data. During the trial, participants will complete a baseline visit before surgery and be evaluated daily for delirium and sleep quality during the first three postoperative days. Researchers will use validated tools to measure delirium incidence and severity, along with self-reported sleep quality. The study includes safety monitoring and aims to complete data collection by November 2027.
CONDITIONS
Brief Title
Daridorexant to Prevent Post-cardiotomy Delirium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Scheduled for surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital
- Able to provide informed consent
- Able to speak, read, and write English
- Has a family member or close friend available for additional information
You will not qualify if you...
- Prior cardiotomy surgery
- Infectious endocarditis
- Emergency surgery
- Delirium present at baseline
- Auditory or visual impairments preventing study procedures
- Alcohol or substance misuse (CAGE-AID score 2 or higher)
- Psychotic disorder
- Dementia-level cognitive deficits (TICS score less than 27)
- Regular use of prescription sleep aids at least every other night
- Use of strong CYP3A4 inhibitors
- Known intolerance to daridorexant
- Severe kidney or liver impairment or on dialysis
- Narcolepsy
- Suicidal thoughts at baseline
- Any condition that may affect patient safety or study data quality
- For exploratory aims: history of traumatic brain injury or head concussions with loss of consciousness, corticosteroid use, major neurological disease, or brain surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 nights after surgery
Participants receive oral daridorexant or matching placebo each night for the first three nights after heart surgery to prevent delirium.
1 baseline visit and 3 in-hospital visits during treatment
Trial Site Locations
Total: 1 location
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
M
Mark Oldham, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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