RecruitingPhase 2NCT07217912

Daridorexant to Prevent Post-cardiotomy Delirium

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

Sponsor

University of Rochester

Enrollment

80 participants

Start Date

Oct 14, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Delirium Postoperative Cognitive Decline

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a sleep medication called daridorexant (a type of sleeping pill that works differently from older sedatives) can prevent delirium — a state of sudden confusion — that sometimes occurs after heart surgery. Delirium is common in older patients after surgery and can delay recovery. **You may be eligible if...** - You are 60 years or older - You are scheduled for heart valve surgery or coronary artery bypass graft (CABG) surgery at Strong Memorial Hospital - You can speak, read, and write English - You have a family member or close friend who can provide information as part of the study **You may NOT be eligible if...** - You have had prior open heart surgery - You have an active heart infection (endocarditis) or need emergency surgery - You show signs of delirium before surgery - You have significant hearing or vision problems that would interfere with study procedures - You have alcohol or substance misuse issues, dementia, or serious memory problems - You take a prescription sleep aid regularly - You have severe kidney or liver disease, or narcolepsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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