Daridorexant to Prevent Post-cardiotomy Delirium

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.

NCT Number	NCT07217912
Lead Sponsor	University of Rochester
Conditions	Postoperative Cognitive Decline, Postoperative Delirium
Enrollment	80 participants
Start Date	2025-10-14
Primary Completion	2027-11-01 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-07