Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 22, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how different types of sounds can help doctors understand the brain activity of critically ill patients who have a disorder of consciousness. Specifically, the researchers want to see if saying a patient's own name in an emotional tone by a familiar voice can produce stronger brain responses compared to saying the same name in a neutral tone by someone they don't know. The goal is to find out if these brain responses can give better clues about a patient's chances of recovery.
To participate in this study, patients must be in the intensive care unit (ICU) due to serious conditions like cardiac arrest or stroke and must show signs of a disorder of consciousness for at least 12 hours after waking up from sedation. They should not be in a very critical state or have conditions like brain death. If eligible, participants can expect to listen to sounds while their brain activity is monitored, which will help researchers gather important information about their condition. This study is currently looking for participants, and it's important to know that only those who meet specific health criteria can take part.
Gender
ALL
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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, Ile De France, France
Paris, Idf, France
Patients applied
Trial Officials
Sarah Benghanem, MD, MSc, PhD student
Principal Investigator
Medical ICU Cochin Hospital, APHP.Centre
Alain Cariou, MD, PhD
Study Director
Medical ICU, Cochin Hospital, APHP.Centre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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