Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630390
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Daridorexant to Prevent Delirium After Heart Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery The main aims this feasibility trial aims to answer are to demonstrate 1 the feasibility of study recruitment 2 the ability deliver study compounds to subjects according to the proposed methods and 3 completeness of data capture and 4 recording of potential adverse events
Participants will 1 complete a baseline visit 2 take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery and 3 be evaluated for sleep and delirium each of the first three days after heart surgery
Participants will 1 complete a baseline visit 2 take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery and 3 be evaluated for sleep and delirium each of the first three days after heart surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None