Daridorexant for Delirium After Heart Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who can consent, undergoing aortic valve replacement or bypass surgery at Strong Memorial Hospital, speak English, and have someone close to help with the study. It's not suitable for those unable to meet these conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete a baseline visit before surgery
Treatment
Participants take the study drug, either daridorexant or placebo, each of the first 3 nights after heart surgery
Evaluation
Participants are evaluated for sleep and delirium each of the first three days after heart surgery
Follow-up
Participants are monitored for delirium and sleep disturbances, continued up to 1 week if delirious on postoperative day 3
What Are the Treatments Tested in This Trial?
Interventions
- Daridorexant
Daridorexant is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor