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NCT Number: NCT06630390

Daridorexant to Prevent Delirium After Heart Surgery

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.

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Key information

Conditions

Postoperative Delirium Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Confusion Delirium Dementia Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Cognitive Decline Postoperative Complications Signs and Symptoms Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
  • Can provide informed consent
  • Able to speak, read, and write English
  • Family member or close friend available for collateral

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 data quality if enrolled in the study

Treatment and study plan

Daridorexant 50 mg

Drug

Administered consistent with labeling from the US Food and Drug Administration.

Placebo

Other

Identical appearing to daridorexant

Primary outcomes

  1. Delirium

    Time frame: First 3 days after surgery

    In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.

Secondary outcomes

  1. Sleep Disturbance

    Time frame: First 3 days after surgery

    When evaluating subjects on each of the first 3 days after surgery, we ask subjects to rate their sleep on the preceding night using Richards-Campbell Sleep Questionnaire. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. Higher scores indicate better sleep. Given that this is a feasibility study, we report the number of subjects evaluated for sleep on each of the postoperative days.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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