Recruiting
Phase 2

Daridorexant

Sponsor:

University of Rochester

Code:

NCT07217912

Conditions

Postoperative Cognitive Decline

Postoperative Delirium

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Daridorexant 50 mg

Placebo

Study Details

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 ID

NCT07217912

Start date

Oct 14, 2025

Status verified date

Jan, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: daridorexant

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

placebo comparator: placebo

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

Interventions

Daridorexant 50 mg

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

Placebo

Identical appearing to daridorexant

Primary outcome measure

  • Delirium incidence and severity [ Time Frame: Postoperative Days 1-3 ]

Central Contacts and Locations

Central contacts

Mark Oldham, MD

585-275-3592mark_oldham@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Mark Oldham, MD

585-275-3592mark_oldham@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • delirium
  • sleep
  • cognitive decline
  • Alzheimer disease and related dementias

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-01-07.