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Recruiting Observational

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

NCT05740735 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-03-25
Last updated
2025-09-12

Condition(s) studied

Disorder of Consciousness

Investigational drug(s) / intervention(s)

Use of "expressive" soundsHaving benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)

Use of "expressive" sounds: Use of "expressive" sounds, that is to say the own first name pronounced by the voice of the relative to generate the P300 and a sound with an "approaching" character of the subject to generate the MMN. The investigators will thus be able to compare: * MMN: present/absent for each modality (neutral vs approaching sounds) * Wave P3a: latencies and amplitudes for each modality (own first name voice of the near vs unfamiliar).

Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds): Retrospective inclusion Have already had an assessment with event related potentials without "emotional" modalities (VF and similar sounds) as part of their care between April 2022 and December 2022 in intensive care at Cochin hospital.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage or head trauma, * persistent disorder of consciousness (DoC) 12 hours after sedation weaning or patient who has benefited from a prognostic assessment for persistent DoC and who has had in this assessment an evaluation by late PEA with MMN and P300 responses only to neutral sounds ("beep" and patient's first name pronounced by an unfamiliar voice) there is more than 6 months (since April 2022) Exclusion Criteria: * Moribund patient * Uncontrolled Shock during the 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

Primary outcome measure(s)

  • Glasgow Outcome Scale-Extended (GOS-E) — Month 3
    Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death

Trial sites (2)

FacilityCityRegionStatus
Medical ICU, HEGP Hospital, APHP.Centre Paris IDF Not Yet Recruiting
Medical ICU, Cochin Hospital, APHP.Centre Paris Île-de-France Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05740735 on ClinicalTrials.gov ↗ ← All trials in France