Daridorexant to prevent delirium after heart surgery
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
This study will test whether taking daridorexant the first three nights after heart surgery can reduce postoperative delirium and improve sleep in people aged 60 and older.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | ceritinib |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07217912 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled pilot trial of daridorexant 50 mg given each of the first three nights after surgical aortic valve replacement or coronary artery bypass grafting. Participants complete a baseline visit, receive daridorexant or placebo in the hospital, and are evaluated daily for delirium symptoms and sleep during the first three postoperative days. The protocol includes an optional wrist-worn sleep monitor to collect objective sleep data in the postoperative setting. The trial follows a prior feasibility effort and is intended to generate preliminary effect estimates to plan a larger phase 2b trial.
Who should consider this trial
Good fit: Ideal candidates are people aged 60 or older having surgical aortic valve replacement or coronary artery bypass grafting at the University of Rochester's Strong Memorial Hospital who can consent and complete English-language assessments.
Not a fit: Patients with baseline delirium or dementia-level cognitive impairment, those undergoing emergency or repeat cardiotomy, people with severe liver or kidney dysfunction, or those taking contraindicated medications or regular prescription sleep aids are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the drug could reduce the incidence and severity of postoperative delirium and improve sleep quality after cardiac surgery.
How similar studies have performed: Using an orexin receptor antagonist to prevent postoperative delirium is a novel application, though a prior feasibility study at the same center supported conducting this randomized pilot and daridorexant is already approved for treating insomnia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 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. Exclusion Criteria: * Prior cardiotomy * Infectious endocarditis * Emergency surgery * Delirium at baseline (positive 3D-CAM) * Auditory or visual impairment that prevents study procedures * Alcohol or substance misuse (CAGE-AID score ≥ 2) * Psychotic disorder * Dementia-level deficits (TICS \< 27) * Use of a prescription sleep aid at least every other night * Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole) * Daridorexant intolerance * Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \<30 mL/min, or on dialysis) * Narcolepsy * Suicidal ideation at baseline * 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
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mark Oldham, MD
- Email: mark_oldham@urmc.rochester.edu
- Phone: 585-275-3592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.