ClinicalTrials.gg
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 9 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 72 studies in Brain Injuries with a site in France — 19 open to participants now, 20 under way, none of them phase 3. Brain Injuries · France.

Planned enrollment
13th of 36
96 · median 46
Started
2024
with 3 others
No phase
26 of 72
7 open now
Primary completion
2027-05
later than 11 of 19 live
Registered
67th of 72
by date

Among the 72 studies in Brain Injuries with a site in France, this one is the 13th largest by planned enrollment of the 36 interventional ones that give a count, is one of 4 that started in 2024, is one of 26 with no phase, reaches primary completion later than 11 of the 19 other live ones, and was the 67th registered.

Brain Injuries

947 studies on the registry are indexed under Brain Injuries; 236 are open to participants now.

Browse Brain Injuries studies →

Open to participants now

19 of the 72 studies in Brain Injuries with a site in France are open now. Recruiting first, the newest first:

13 more — sign in →

All 19 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 152 Brain Injuries studies recruiting now, 75 (49%) set no upper age limit and 55 (36%) stop at 75 or younger; 39 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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

03

Conditions studied

  • Disorders of Consciousness Due to Severe Brain Injury
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for May 2027, 39 months after the start.

Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 39 months is above that.

Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Aug 17, 2025
StartActual
Feb 5, 2024
Primary completionEst.
May 5, 2027
CompletionEst.
May 5, 2027
Last update
Aug 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
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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