Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients) (NCT07127224) | Clinical Trial Compass
RecruitingNot Applicable
Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)
France96 participantsStarted 2024-02-05
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glasgow Outcome Scale-Extended (GOS-E) score at 3 months