NCT05740735 Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
| NCT ID | NCT05740735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Disorder of Consciousness |
| Study Type | OBSERVATIONAL |
| Enrollment | 114 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 114 participants in total. It began in 2024-03-25 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sarah Benghanem, MD, MSc, PhD student
PRINCIPAL INVESTIGATOR
Medical ICU Cochin Hospital, APHP.Centre
Frequently Asked Questions
Who can join the NCT05740735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disorder of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05740735 currently recruiting?
Yes, NCT05740735 is actively recruiting participants. Contact the research team at sarah.benghanem@aphp.fr for enrollment information.
Where is the NCT05740735 trial being conducted?
This trial is being conducted at Paris, France, Paris, France.
Who is sponsoring the NCT05740735 clinical trial?
NCT05740735 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Sarah Benghanem, MD, MSc, PhD student at Medical ICU Cochin Hospital, APHP.Centre. The trial plans to enroll 114 participants.