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Daridorexant to Prevent Delirium After Heart Surgery

NCT06630390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-07-11

Study results available
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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

DRUG

Daridorexant 50 mg

Administered consistent with labeling from the US Food and Drug Administration.

OTHER

Placebo

Identical appearing to daridorexant

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Mark A Oldham, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-02-16
Completion
2025-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630390 on ClinicalTrials.gov