Actively Recruiting

Phase 2
Age: 60Years +
All Genders
NCT07217912

Daridorexant to Prevent Post-cardiotomy Delirium

Led by University of Rochester · Updated on 2026-01-07

80

Participants Needed

1

Research Sites

106 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Daridorexant to Prevent Post-cardiotomy Delirium

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 60 years or older
  • Scheduled for surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital
  • Able to provide consent
  • Able to speak, read, and write English
  • Have a family member or close friend available for collateral information
Not Eligible

You will not qualify if you...

  • Prior cardiotomy surgery
  • Infectious endocarditis
  • Emergency surgery
  • Delirium present at baseline (positive 3D-CAM)
  • Auditory or visual impairment preventing study procedures
  • Alcohol or substance misuse (CAGE-AID score 2 or higher)
  • Psychotic disorder
  • Dementia-level cognitive deficits (TICS score less than 27)
  • Use of prescription sleep aids at least every other night
  • Use of strong CYP3A4 inhibitors (e.g., ceritinib, clarithromycin, ritonavir)
  • Intolerance to daridorexant
  • Severe kidney or liver impairment (Child-Pugh score 7 or higher, Cockcroft-Gault less than 30 mL/min, or on dialysis)
  • Narcolepsy
  • Suicidal ideation at baseline
  • Any condition that compromises patient safety or data quality as judged by the principal investigator
  • Additional exclusions for NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

M

Mark Oldham, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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