Daridorexant to Prevent Post-cardiotomy Delirium

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07217912
Phase
PHASE2
Status
Recruiting
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Conditions

  • Postoperative Cognitive Decline
  • Postoperative Delirium

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 50 mg — DRUG
    Administered consistent with labeling from the US Food and Drug Administration.
  • Placebo — OTHER
    Identical appearing to daridorexant

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Jan 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: daridorexant
    Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
  • Placebo Comparator: placebo
    Oral matching placebo each of the first three nights after heart surgery.

Primary Outcome Measure

Delirium incidence and severity [ Time Frame: Postoperative Days 1-3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Mark Oldham, MD
[email protected]
585-275-3592

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By research site
University of Rochester Medical Center· Rochester, NY

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