Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

NCT07127224 | Recruiting

• 1 other identifier: D21-P017
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Disorders of Consciousness Due to Severe Brain Injury

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale-Extended (GOS-E) score at 3 months

  3 months after inclusion

Study Arms (1)

Patients with disorders of consciousness

EXPERIMENTAL

Adult ICU patients with disorders of consciousness will undergo non-invasive neurophysiological assessments including olfactory, auditory, and somatosensory stimulations. Olfactory stimuli are added for prognostic evaluation. Clinical and neurological follow-up will be done at 3 months.

Diagnostic Test: Olfactory stimulation

Interventions

Olfactory stimulation DIAGNOSTIC_TEST

Olfactory stimulation ("sniff" test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients.

Patients with disorders of consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Psychiatrie et Neurosciences

Paris, GHU Psychiatrie Et Neurosciences, 75014, France

RECRUITING

Central Study Contacts

Eleonore BOUCHEREAU, MD, PhD

CONTACT

0145658902; e.bouchereau@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: February 5, 2024
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 5, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

FR (1)