Daridorexant to Prevent Delirium After Heart Surgery

University of Rochester11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

POSTOPERATIVE DELIRIUM POSTOPERATIVE COGNITIVE DECLINE

Interventions

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: First 3 days after surgery

Secondary Outcomes

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.