At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
In Brief
A Phase 2 clinical trial evaluating Daridorexant 50 mg and Placebo for POSTOPERATIVE DELIRIUM and POSTOPERATIVE COGNITIVE DECLINE. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Administered consistent with labeling from the US Food and Drug Administration.
Identical appearing to daridorexant