Condition: Postoperative Cognitive Decline · Postoperative Delirium · Sponsor: University of 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.
This description comes directly from the study's public registry record.
Mark Oldham, MD · 585-275-3592 · mark_oldham@urmc.rochester.edu
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| University of Rochester Medical Center | Rochester, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07217912