Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

NCT ID: NCT07127224

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2027-05-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with disorders of consciousness

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.

Group Type: EXPERIMENTAL

Olfactory stimulation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Olfactory stimulation

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHU Psychiatrie et Neurosciences

Paris, GHU Psychiatrie Et Neurosciences, France

Site Status: RECRUITING

Countries

France

Central Contacts

Eleonore BOUCHEREAU, MD, PhD

Role: CONTACT

e.bouchereau@ghu-paris.fr

0145658902 ext. +33

Facility Contacts

Role: primary

k.sylla@ghu-paris.fr

0145657678

Other Identifiers

D21-P017

Identifier Type: -

Identifier Source: org_study_id