Daridorexant to Prevent Delirium After Heart Surgery

Randomized, Double-blind Trial of 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.

Study Overview

• Status: Completed
• Conditions: POSTOPERATIVE DELIRIUM; POSTOPERATIVE COGNITIVE DECLINE
• Intervention / Treatment: Drug: Daridorexant 50 mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daridorexant; Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.	Drug: Daridorexant 50 mg; Administered consistent with labeling from the US Food and Drug Administration.
Placebo Comparator: Placebo; Oral matching placebo each of the first three nights after heart surgery.	Other: Placebo; Identical appearing to daridorexant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	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.	First 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance	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.	First 3 days after surgery

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Mark A Oldham, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): February 16, 2025
• Study Completion (Actual): February 16, 2025

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: delirium; sleep; cognitive decline; Alzheimer disease and related dementias
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Emergence Delirium; Delirium; Cognitive Dysfunction
• Other Study ID Numbers: STUDY00009841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This trial is designed to demonstrate feasibility rather than test hypotheses of efficacy. As such, the data that will be obtained would be of very limited value if shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No