Daridorexant to Prevent Delirium After Heart Surgery

Phase 2

Completed

• Conditions: POSTOPERATIVE DELIRIUM; POSTOPERATIVE COGNITIVE DECLINE
• Interventions: Drug: Daridorexant 50 mg; Other: Placebo

• Registration Number: NCT06630390
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Study Start: 2024-11-11
• Primary Completion: 2025-02-16
• Study Completion: 2025-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daridorexant	Daridorexant 50 mg	Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Placebo	Placebo	Oral matching placebo each of the first three nights after heart surgery.

Primary Outcome Measures

Name	Time	Method
Delirium	First 3 days after surgery (continued up to 1 week if delirious on postop day 3)	Participants will be evaluated 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 will be diagnosed using the information from these two assessments.

Secondary Outcome Measures

Name	Time	Method
Sleep disturbance	First 3 days after surgery (continued up to 1 week if delirious on postop day 3)	Participants will be evaluated using the Richards-Campbell Sleep Questionnaire each day after surgery. On a scale of 1 to 10 (with 1 being "poor" and 10 being "excellent"), patients rate the overall quality of their sleep at the ICU.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States