NCT07127224 Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
| NCT ID | NCT07127224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Disorders of Consciousness Due to Severe Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-05-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2024-02-05 with a primary completion date of 2027-05-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07127224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disorders of Consciousness Due to Severe Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07127224 currently recruiting?
Yes, NCT07127224 is actively recruiting participants. Contact the research team at e.bouchereau@ghu-paris.fr for enrollment information.
Where is the NCT07127224 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07127224 clinical trial?
NCT07127224 is sponsored by Centre Hospitalier St Anne. The trial plans to enroll 96 participants.