Actively Recruiting
Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
Led by Centre Hospitalier St Anne · Updated on 2025-08-17
96
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to determine whether the clinical response to olfactory stimulation (known as the "sniff" response) can help predict 3-month neurological outcomes in ICU patients with persistent disorders of consciousness after sedation withdrawal, regardless of the reason for admission or the initial severity. The main questions this study aims to answer are: * Can the "sniff" response to olfactory stimulation predict neurological outcomes at 3 months? * Is this response a better prognostic indicator than commonly used neurophysiological tests? Researchers will compare the results obtained from olfactory stimulation with those from somatosensory and auditory stimulations to determine whether the olfactory method provides additional or superior prognostic value. Participants will receive additional olfactory stimuli as part of the neurophysiological evaluation for prognostic purposes and be followed up at 3 months for clinical, neurological, and functional evaluation
CONDITIONS
Official Title
Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to neuro-intensive care unit (neuro-ICU)
- Age 6 18 years
- Patients with persistent disorders of consciousness defined by an abnormal CRS-R score (<16) at 72 hours after sedation withdrawal and spontaneous ventilation
- Consent obtained from legal representatives or activation of emergency waiver
- Patient covered by or affiliated with a social security system
You will not qualify if you...
- Pregnancy
- Brain death
- Pre-existing ENT or olfactory bulb pathologies that may affect olfactory functions
- Acute or chronic peripheral neurological diseases that may alter evoked potentials
- Known neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease)
- Patients under legal guardianship or protective supervision (safeguard or protection measures)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GHU Psychiatrie et Neurosciences
Paris, GHU Psychiatrie Et Neurosciences, France, 75014
Actively Recruiting
Research Team
E
Eleonore BOUCHEREAU, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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