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RecruitingNCT07127224CEOSUpdated Aug 17, 2025

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

An interventional study of Olfactory stimulation in Disorders of Consciousness Due to Severe Brain Injury, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Feb 2024, registered Aug 2025).
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Disorders of Consciousness Due to Severe Brain Injury
03

In context

Lead sponsor

Centre Hospitalier St Anne is the lead sponsor of 99 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    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.

    Diagnostic Test: Olfactory stimulation

Interventions

  • Diagnostic testOlfactory stimulation

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months after inclusion

07

Study locations

1 of 1 sites recruiting
  • GHU Psychiatrie et Neurosciences
    Paris, GHU Psychiatrie Et Neurosciences 75014, France
    • · Contact · k.sylla@ghu-paris.fr · 0145657678
    • Eleonore BOUCHEREAU, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07127224
Lead sponsor
Centre Hospitalier St Anne
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Feb 5, 2024
Primary completion
May 5, 2027 (estimated)
Completion
May 5, 2027 (estimated)
Last update
Aug 17, 2025

Study contacts

Eleonore BOUCHEREAU, MD, PhD
Contact
e.bouchereau@ghu-paris.fr
0145658902 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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