Daridorexant to Prevent Delirium After Heart Surgery

Last updated: June 23, 2025
Sponsor: University of Rochester
Overall Status: Completed

Phase

2

Condition

Mental Disability

Memory Loss

Memory Problems

Treatment

Daridorexant 50 mg

Placebo

Clinical Study ID

NCT06630390
STUDY00009841
  • Ages > 60
  • All Genders

Study Summary

The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.

Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having surgical aortic valve replacement or coronary artery bypass graft surgery atStrong Memorial Hospital

  • Can provide informed consent

  • Able to speak, read, and write English

  • Family member or close friend available for collateral

Exclusion

Exclusion Criteria:

  • Prior heart surgery

  • Infectious endocarditis

  • Emergency surgery

  • Delirium at baseline

  • Auditory/visual impairment preventing study procedures

  • Active alcohol or substance misuse

  • Psychotic disorder

  • Dementia-level deficits

  • Use of a sleep aid before surgery

  • Use of a strong 3A4 inhibitor

  • Intolerance to daridorexant

  • Severe kidney or liver impairment

  • Narcolepsy

  • Any condition that, in the opinion of the PI, compromises patient safety or dataquality if enrolled in the study

Study Design

Total Participants: 11
Treatment Group(s): 2
Primary Treatment: Daridorexant 50 mg
Phase: 2
Study Start date:
November 11, 2024
Estimated Completion Date:
February 16, 2025

Connect with a study center

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.