Phase 2 Randomized Trial of Daridorexant to Prevent Delirium After Heart Surgery Including Aortic Valve and Coronary Artery Bypass Grafts Evaluating Sleep Quality and Delirium Outcomes

What this Trial Is About

Researchers are conducting a pilot randomized clinical trial to gather preliminary data on the use of daridorexant for preventing delirium after heart surgery, specifically focusing on patients aged 60 and older undergoing aortic valve or coronary artery bypass graft surgery. This study builds on prior feasibility work and aims to assess daridorexants impact on reducing delirium symptoms and incidence, improving sleep quality, and evaluating the practicality of collecting objective sleep data postoperatively. Participants will be randomly assigned to receive either oral daridorexant at 50 mg or 25 mg if taking certain medications or a matching placebo each night for the first three nights following heart surgery. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. There is also an option for participants to wear a sleep monitor during these nights to collect additional sleep quality data. During the trial, participants will complete a baseline visit before surgery and be evaluated daily for delirium and sleep quality during the first three postoperative days. Researchers will use validated tools to measure delirium incidence and severity, along with self-reported sleep quality. The study includes safety monitoring and aims to complete data collection by November 2027.

Daridorexant to Prevent Post-cardiotomy Delirium