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NCT Number: NCT07217912

Daridorexant to Prevent Post-cardiotomy Delirium

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daridorexant 50 mg

Drug

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

Placebo

Other

Identical appearing to daridorexant

Primary outcomes

  1. Delirium incidence and severity

    Time frame: Postoperative Days 1-3

    Participants will be assessed on postoperative days 1-3 using the Delirium Rating Scale, Revised-98 (DRS-R98; range 0-39; higher scores indicate greater severity of delirium symptoms) and 3-minute Diagnostic interview for the Confusion Assessment Method (3D-CAM; 22 dichotomous items used to inform delirium status). Delirium diagnosis is defined per Diagnostic and Manual of Mental Disorders, 5th Edition, Text Revision, and its severity defined as the sum of DRS-R98 score on postoperative days 1-3.

Secondary outcomes

  1. Postoperative sleep quality

    Time frame: Postoperative Nights 1-3

    Participants will complete Richards-Campbell Sleep Questionnaire on postoperative days 1-3. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. The total score represents the mean of the first five domain scores. Higher scores indicate better subjective sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Oldham, MD

CONTACT

[email protected]

585-275-3592

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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