Daridorexant to Prevent Post-cardiotomy Delirium

About this trial

Last updated 5 months ago

Study ID

STUDY000010860

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

60+ Years

All Sexes

Trial Timing

Started 8 months ago

What is this trial about?

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.

What are the participation requirements?

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