NCT07217912

Daridorexant to Prevent Post-cardiotomy Delirium

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting. Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.

Conditions

• Postoperative Cognitive Decline
• Postoperative Delirium

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: 2025-10-14
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-10-20
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study