Actively Recruiting

Age: 18Years +
All Genders
NCT05740735

Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12

114

Participants Needed

2

Research Sites

127 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine if the use of emotional sound as subject own name (SON) pronounced by a familiar voice (FV) compared to SON pronounced by a non-familiar voice (NFV) during event related potential (ERP) produced a more reliable neurophysiological P300 responses, and to assess the prognostic value of this P300 responses induced by the SON with a FV.

CONDITIONS

Official Title

Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage, or head trauma
  • Persistent disorder of consciousness 12 hours after sedation weaning
  • Patients previously assessed with event related potentials using only neutral sounds between April 2022 and December 2022
Not Eligible

You will not qualify if you...

  • Moribund patient
  • Uncontrolled shock during neurophysiological evaluation
  • Sedated patient
  • Minor patient
  • Brain death
  • Known deafness
  • Pregnant woman
  • Prior inclusion in the study
  • Patient not affiliated to a social security system
  • Implementation of limitations and stop of active therapies
  • Patient under legal protection
  • Patient benefiting from State Medical Aid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Medical ICU, HEGP Hospital, APHP.Centre

Paris, IDF, France, 75015

Not Yet Recruiting

2

Medical ICU, Cochin Hospital, APHP.Centre

Paris, Île-de-France Region, France, 75014

Actively Recruiting

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Research Team

S

Sarah Benghanem, MD, MSc, PhD student

CONTACT

M

Marie BENHAMMANI-GODARD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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