11 Participants Needed

Daridorexant for Delirium After Heart Surgery

MA
JN
Overseen ByJabob Nadler, MD, PhD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

Able to speak, read, and write English
Family member or close friend available for collateral
I am having heart valve or bypass surgery at Strong Memorial Hospital.
See 1 more

Exclusion Criteria

Auditory/visual impairment preventing study procedures
I have been diagnosed with infectious endocarditis.
Psychotic disorder
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a baseline visit before surgery

1 day
1 visit (in-person)

Treatment

Participants take the study drug, either daridorexant or placebo, each of the first 3 nights after heart surgery

3 days
Daily evaluations (in-person)

Evaluation

Participants are evaluated for sleep and delirium each of the first three days after heart surgery

3 days
Daily evaluations (in-person)

Follow-up

Participants are monitored for delirium and sleep disturbances, continued up to 1 week if delirious on postoperative day 3

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Daridorexant
Trial Overview The trial tests if Daridorexant helps prevent confusion or 'brain fog' after heart surgery compared to a placebo. Participants take the drug or placebo for three nights post-surgery and are checked for sleep quality and delirium.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DaridorexantExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Daridorexant is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Quviviq for:
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Approved in European Union as Quviviq for:
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Approved in Canada as Quviviq for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+
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