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Daridorexant to Prevent Post-cardiotomy Delirium
Sponsor: University of Rochester
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.
Official title: Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-14
Completion Date
2027-11-01
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
Daridorexant 50 mg
Administered consistent with labeling from the US Food and Drug Administration.
Placebo
Identical appearing to daridorexant
Locations (1)
University of Rochester Medical Center
Rochester, New York, United States