Disorders of Consciousness Due to Severe Brain InjuryCEOSNCT07127224
Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
A study testing Olfactory stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Consciousness Due to Severe Brain Injury
- What is being tested?
- Olfactory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 5 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHU Psychiatrie et Neurosciences
Paris, GHU Psychiatrie Et Neurosciences, 75014
0145657678, k.sylla@ghu-paris.fr
Eleonore BOUCHEREAU, MD, PhD
About this study
Official title: 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:
Read more
- 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
- Being tested
- Olfactory stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory stimulationDiagnostic test
Olfactory stimulation ("sniff" test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Olfactory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale-Extended (GOS-E) score at 3 months
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start5 Feb 2024
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Consciousness Due to Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127224
- Sponsor's protocol ID
- D21-P017
- Acronym
- CEOS
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients
- ClinicalTrials.gov ID
- NCT07127224
- Acronym / sponsor ID
- CEOS / D21-P017
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with disorders of consciousness | Experimental | Diagnostic Test: Olfactory stimulationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory stimulationOlfactory stimulation ("sniff" test) combined with auditory and somatosensory stimulations during bedside neurophysiological assessments to evaluate neurological prognosis in ICU patients. | Diagnostic test | Patients with disorders of consciousness |
Primary outcome
Glasgow Outcome Scale-Extended (GOS-E) score at 3 months
Time frame: 3 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory stimulation in people with Disorders of Consciousness Due to Severe Brain Injury, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonore BOUCHEREAU, MD, PhD (0145658902 ext. +33, e.bouchereau@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale-Extended (GOS-E) score at 3 months (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.