Daridorexant to Prevent Delirium After Heart Surgery

Phase 2

Completed

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.

Recruitment & Eligibility

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

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	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 Outcome Measures

Name	Time	Method
Sleep Disturbance	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.

Locations (1): University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States