NCT07127224

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Disorders of Consciousness Due to Severe Brain Injury

Interventions

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

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-05-05
• Completion: 2027-05-05
• First posted: 2025-08-17
• Last updated: 2025-08-17

Locations

1 site across 1 country: France