Phase 2 N=11 Randomized Quadruple-blind Prevention

Daridorexant to Prevent Delirium After Heart Surgery

POSTOPERATIVE DELIRIUM · POSTOPERATIVE COGNITIVE DECLINE

Bottom Line

View on ClinicalTrials.gov: NCT06630390 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Jul 2025

Primary outcome: Primary: Delirium — 5; 6; 5; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Daridorexant 50 mg (Drug); Placebo (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Delirium	5; 6; 5; 6; 5; 5	—
SECONDARY Sleep Disturbance	5; 6; 5; 6; 5; 5	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06630390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.