Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT07217912
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07217912
Study Brief:
Protocol Section:
NCT07217912