Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT07217912
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daridorexant to Prevent Post-cardiotomy Delirium
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: