Daridorexant to Prevent Post-cardiotomy Delirium

NCT ID: NCT07217912

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2027-11-01

Brief Summary

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.

Conditions

Postoperative Cognitive Decline; Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

daridorexant

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

Group Type: EXPERIMENTAL

Daridorexant 50 mg

Intervention Type: DRUG

Administered consistent with labeling from the US Food and Drug Administration.

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Identical appearing to daridorexant

Interventions

Daridorexant 50 mg

Administered consistent with labeling from the US Food and Drug Administration.

Intervention Type: DRUG

Placebo

Identical appearing to daridorexant

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Mark Oldham

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark Oldham, MD

Role: CONTACT

mark_oldham@urmc.rochester.edu

585-275-3592

Facility Contacts

Mark Oldham, MD

Role: primary

mark_oldham@urmc.rochester.edu

585-275-3592

Other Identifiers

STUDY000010860

Identifier Type: -

Identifier Source: org_study_id