Daridorexant to Prevent Delirium After Heart Surgery

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06630390
Phase
PHASE2
Status
Completed

Conditions

  • POSTOPERATIVE COGNITIVE DECLINE
  • POSTOPERATIVE DELIRIUM

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Jun 2025
Primary completion
Feb 16, 2025
Completion
Feb 16, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Daridorexant
    Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
  • Placebo Comparator: Placebo
    Oral matching placebo each of the first three nights after heart surgery.

Primary Outcome Measure

Delirium [ Time Frame: First 3 days after surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642-

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By research site
University of Rochester Medical Center· Rochester, NY

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