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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the response to smells, called the "sniff" response, can help predict neurological outcomes three months after sedation withdrawal in adults in the ICU with persistent disorders of consciousness. The study compares this olfactory response with other common tests like auditory and somatosensory stimulations to see if it provides better or additional information about recovery. This observational study aims to improve prognosis predictions for patients with severe brain injuries causing consciousness disorders. Participants are adult ICU patients who will undergo non-invasive neurophysiological tests involving olfactory, auditory, and somatosensory stimulations at the bedside. The olfactory stimulation is added specifically to assess prognosis. The study group includes patients with persistent disorders of consciousness after sedation withdrawal. There are no experimental treatments; instead, the focus is on diagnostic testing and monitoring. During the study, participants will be followed up three months after inclusion to assess their clinical, neurological, and functional status. The main outcome measured is the Glasgow Outcome Scale-Extended (GOS-E) score at three months, which evaluates recovery level. Researchers will track responses from all stimulations to compare their ability to predict outcomes. The total participation involves initial assessments in the ICU and a follow-up evaluation at three months.
CONDITIONS
Brief 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 18 years or older
- Persistent disorders of consciousness with an abnormal CRS-R score less than 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 affecting olfactory functions
- Acute or chronic peripheral neurological diseases that may alter evoked potentials
- Known neurodegenerative diseases such as Parkinson's disease or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 72 hours after sedation withdrawal
Participants undergo non-invasive neurophysiological assessments including olfactory, auditory, and somatosensory stimulations to evaluate neurological prognosis.
1 to 2 bedside assessment visits
Duration - 3 months after inclusion
Participants are clinically and neurologically followed up to assess outcomes after initial diagnostic evaluation.
1 follow-up visit at 3 months
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
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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