Using emotional sounds to assess consciousness in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the neurophysiological responses of critically ill patients with a disorder of consciousness by comparing their reactions to emotional sounds of their own name spoken by a familiar voice versus a non-familiar voice. It focuses on measuring event-related potentials (ERPs), specifically the P300 response, to determine the prognostic value of these responses in assessing patient outcomes. The study is conducted in intensive care units and involves patients who have experienced cardiac arrest, stroke, or head trauma. By utilizing advanced neurophysiological techniques, the research seeks to improve the accuracy of consciousness assessments in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical ICU, Cochin Hospital, APHP.Centre
  Paris, Île-de-France Region, France Recruiting
• Medical ICU, HEGP Hospital, APHP.Centre
  Paris, Idf, France Not yet recruiting

Study contacts

• Principal investigator: Sarah Benghanem, MD, MSc, PhD student — Medical ICU Cochin Hospital, APHP.Centre
• Study coordinator: Sarah Benghanem, MD, MSc, PhD student
• Email: sarah.benghanem@aphp.fr
• Phone: 0033158412533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.