NCT06630390

Daridorexant to Prevent Delirium After Heart Surgery

Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• POSTOPERATIVE DELIRIUM
• POSTOPERATIVE COGNITIVE DECLINE

Interventions

Type	Name	Description
DRUG	Daridorexant 50 mg	Administered consistent with labeling from the US Food and Drug Administration.
OTHER	Placebo	Identical appearing to daridorexant

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-02-16
• Completion: 2025-02-16
• First posted: 2024-10-08
• Last updated: 2025-07-11
• Results posted: 2025-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study