NCT06630390CompletedPhase 2
Daridorexant to Prevent Delirium After Heart Surgery
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 30 Sept 2024
- Start date
- 11 Nov 2024
- Primary completion date
- 16 Feb 2025
- Lead sponsor
- University of Rochester
- Diseases
- Alzheimer disease
- NCT number
- NCT06630390
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 11
- From 11 Nov 2024 to the primary completion date, 16 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior heart surgery
- Emergency surgery
- Use of a sleep aid before surgery
- Use of a strong 3A4 inhibitor
Other illness
- Auditory/visual impairment preventing study procedures
- Psychotic disorder
- Dementia-level deficits
- Severe kidney or liver impairment
- Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study
Other
- Infectious endocarditis
- Delirium at baseline
- Active alcohol or substance misuse
- Intolerance to daridorexant
- Narcolepsy
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.