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Daridorexant to Prevent Post-cardiotomy Delirium

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Enrolling by Invitation to Recruiting
    • Start date changed from estimate of Oct 20, 2025 to Oct 14, 2025
    • Site details revised
    v3
  3. Secondary endpoints: details revised at 1 of 1 entry
    • Study title shortened, about 6 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07217912
Lead Sponsor University of Rochester
Conditions
(from sponsor)		 Postoperative Cognitive Decline, Postoperative Delirium
Related terms Alzheimer Disease, Cognitive Dysfunction, Delirium, Emergence Delirium, Postoperative Cognitive Complications
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov