Overview

Daridorexant to Prevent Post-cardiotomy Delirium

Status:
ENROLLING_BY_INVITATION
Trial end date:
2027-11-01
Target enrollment:
Participant gender:
Summary
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving sleep quality during the postoperative period, and (3) to assess the feasibility of collecting audiovisual data before surgery for natural language processing as a potential biomarker of delirium risk. Participants will: (1) complete a baseline visit; (2) provide a short preoperative audiovisual recording; (3) take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and (4) be evaluated daily for sleep and delirium during the first three postoperative days.
Phase:
PHASE2
Details
Lead Sponsor:
University of Rochester
Treatments:
daridorexant