Using emotional sounds to assess consciousness in critically ill patients
Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness (DOC)
This study is testing if critically ill patients can show signs of awareness by measuring their brain responses to hearing their name spoken by someone they know compared to a stranger.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris, IDF and 1 other locations) |
| Trial ID | NCT05740735 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include ICU patients with persistent disorders of consciousness following cardiac arrest, stroke, or head trauma.
Not a fit: Patients who are moribund, brain dead, or have known deafness will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict recovery outcomes in critically ill patients with disorders of consciousness.
How similar studies have performed: While some studies have explored neurophysiological assessments in similar contexts, this specific approach using emotional sounds is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, IDF and 1 other locations
- Medical ICU, HEGP Hospital, APHP.Centre — Paris, Idf, France (Not_yet_recruiting)
- Medical ICU, Cochin Hospital, APHP.Centre — Paris, Île-de-France Region, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.