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NCT Number: NCT07127224

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

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

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Key information

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHU Psychiatrie et Neurosciences

Paris, GHU Psychiatrie Et Neurosciences, 75014, France

Location status: Recruiting

Location contact

Eleonore BOUCHEREAU, MD, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

0145657678

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3 months after inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonore BOUCHEREAU, MD, PhD

CONTACT

[email protected]

0145658902 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients

Acronym: CEOS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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