Rochester, NYNCT07217912Now EnrollingIRB Ready

Postoperative Cognitive Decline Clinical Trial in Rochester, NY

Access cutting-edge postoperative cognitive decline treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by University of Rochester

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Expert Care in Rochester

Access postoperative cognitive decline specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related postoperative cognitive decline treatment provided free

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Check if you qualify for this postoperative cognitive decline clinical trial in Rochester, NY

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Postoperative Cognitive Decline Study in Rochester

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.

Sponsor: University of Rochester

Who Can Participate

Inclusion Criteria

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)
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07217912) has an active research site in Rochester, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Postoperative Cognitive Decline Treatment Options in Rochester, NY

If you're searching for postoperative cognitive decline treatment options in Rochester, NY, this clinical trial (NCT07217912) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced postoperative cognitive decline specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all postoperative cognitive decline clinical trials near you to find additional studies recruiting in your area.

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