Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT07217912
Brief Summary:
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 sleep quality during the postoperative period, and (3) to assess the feasibility of collecting audiovisual data before surgery for natural language processing as a potential biomarker of delirium risk.
Participants will: (1) complete a baseline visit; (2) provide a short preoperative audiovisual recording; (3) take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and (4) be evaluated daily for sleep and delirium during the first three postoperative days.
Study:
NCT07217912
Study Brief:
Protocol Section:
NCT07217912