Daridorexant for Delirium After Heart Surgery

Overseen By Jabob Nadler, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Must not be taking: Sleep aids, Strong 3A4 inhibitors

Disqualifiers: Prior heart surgery, Psychotic disorder, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

Exclusion Criteria

Auditory/visual impairment preventing study procedures

I have been diagnosed with infectious endocarditis.

Psychotic disorder

Treatment Details

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.

Participant Groups

Group I: Daridorexant Experimental Treatment 1 Intervention

Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.

Group II: Placebo Placebo Group 1 Intervention

Oral matching placebo each of the first three nights after heart surgery.

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

Approved in United States as Quviviq for:

• Insomnia

Approved in European Union as Quviviq for:

• Insomnia

Approved in Canada as Quviviq for:

• Insomnia

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+