Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
Recruiting now · Not applicable
Conditions studied: Disorders of Consciousness Due to Severe Brain Injury
In brief
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
Key facts
- Study ID
- NCT07127224
- Run by
- Centre Hospitalier St Anne
- People needed
- 96
- Starts
- 2024-02-05
- Expected to finish
- 2027-05-05
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admission to neuro-intensive care unit (neuro-ICU)
- Age ≥ 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 may not qualify if…
- 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)
Where it is running
- GHU Psychiatrie et Neurosciences — Paris, GHU Psychiatrie Et Neurosciences, France (enrolling)
Full record on ClinicalTrials.gov
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