NCT07217912RecruitingPhase 2
Daridorexant to Prevent Post-cardiotomy Delirium
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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 self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting. Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 14 Oct 2025
- Start date
- 14 Oct 2025
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- University of Rochester
- Diseases
- Alzheimer disease
- NCT number
- NCT07217912
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 14 Oct 2025 to the primary completion date, 1 Nov 2027
- 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 cardiotomy
- Emergency surgery
- Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)
Other illness
- Auditory or visual impairment that prevents study procedures
- Psychotic disorder
- Dementia-level deficits (TICS \< 27)
- Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \<30 mL/min, or on dialysis)
- Any condition that, in the PI's opinion, compromises patient safety or data quality
- Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery
Other
- Infectious endocarditis
- Delirium at baseline (positive 3D-CAM)
- Alcohol or substance misuse (CAGE-AID score ≥ 2)
- Use of a prescription sleep aid at least every other night
- Daridorexant intolerance
- Narcolepsy
- Suicidal ideation at baseline
Who the study is looking for
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- family member or close friend 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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.