RecruitingNAINTERVENTIONAL

Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)

This study, called "Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients," is exploring a new way to understand recovery in people who are in a coma or have serious brain injuries. Researchers are interested in whether a simple 'sniff' response to different smells can help predict how well these patients will recover three months after their injury. They will compare this sniff test to other common brain tests to see if it provides clearer or more helpful information about a patient's future. The study aims to improve how doctors understand and talk about recovery chances for patients with disorders of consciousness.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier St Anne

Enrolment target

Start

05 Feb 2024

Estimated completion

05 May 2027

Disorders of Consciousness Due to Severe Brain Injury

What is this study about?

This study aims to discover if a simple 'sniff' test can help doctors better understand the recovery prospects for patients who have severe brain injuries and are in a coma or have other disorders of consciousness. When someone has a serious brain injury, it can be very difficult for doctors to predict how well they might recover.

Researchers will gently introduce different smells to these patients and observe if they show a 'sniff' response. They believe that this response might be a good indicator of how a patient's brain is working and how they might recover in the coming months. This information could be really valuable for families and doctors trying to make important decisions about care.

The study also wants to see if this 'sniff' test is more accurate or helpful than the usual brain tests doctors currently use. By comparing the 'sniff' test results with other tests, the researchers hope to find new and more reliable ways to predict patient outcomes three months after their injury, regardless of what caused the initial brain injury or how severe it was at first.

Key takeaways

This study uses smell tests to predict recovery after a severe brain injury.
It aims to find better ways to understand a patient's prognosis (outlook).
Participation involves extra smell tests and a follow-up at 3 months.
There are no new treatments, only observations.
The findings could help future patients and their families.
Your legal representative must give consent.

Who may be eligible?

To take part in this study, you must be at least 18 years old and currently in a special brain injury unit (neuro-intensive care unit). You would have been off sedatives for at least 72 hours, breathing on your own, and still showing signs of a disorder of consciousness.

Your legal representative (someone who can make decisions for you) would need to give permission for you to join the study, or special emergency consent rules might apply. You also need to be part of a social security system or have medical coverage.

You would not be able to join if you are pregnant, have been diagnosed with brain death, or have existing nose or smell problems. People with certain nerve problems affecting their brain test results or those with known conditions like Parkinson's or Alzheimer's disease are also not eligible. Additionally, if you are under certain legal care arrangements that limit your decision-making, you cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Are you in a neuro-intensive care unit (NICU)?
Have you been off sedatives for at least 3 days and are breathing on your own?
Do you currently have a disorder of consciousness?
Do you *not* have pre-existing serious nose/smell problems or other specific nerve or brain diseases?
Is a legal representative available to give consent for your participation?

Answer every question to see your result.

What does participation involve?

If you participate in this study, you will receive some additional smell tests as part of your regular brain evaluations. These tests involve introducing different scents to see if you show a 'sniff' response. Researchers will carefully observe your reactions. After this initial assessment, you will be followed up at your hospital at three months. During this follow-up, doctors will check your overall health, your neurological condition, and how well you are able to perform daily activities. This is an observational study, so you won't be given any new medications or treatments that are different from your usual care. The total duration of your participation, including follow-up, will be around three months.

Potential risks and benefits

As this is an observational study, there are no new medications or treatments involved, so the direct medical risks are expected to be very low. The main potential benefit is that the study might lead to a better understanding of how to predict recovery for patients with severe brain injuries, which could help many future patients and their families. There are no direct benefits to you as an individual participant. You or your legal representative have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

GHU Psychiatrie et Neurosciences
Verified postcode
Paris, France· Recruiting

Common questions

What is a 'disorder of consciousness'?

It means someone has a severe brain injury and isn't fully awake or aware of their surroundings, sometimes known as a coma or vegetative state.

What does 'olfactory stimulation' mean?

It's a fancy way of saying using different smells to see how someone reacts, like whether they sniff in response.

Will I get different medical treatment if I join?

No, this study only involves extra tests – you will continue to receive your usual medical care and treatments.

Why is a 'sniff' response important?

Researchers believe that sniffing in response to smells might show how well certain parts of the brain are working and could help predict recovery after a brain injury.

Who decides if I can be in the study?

Because you might not be able to decide for yourself, your legal representative (like a close family member) would give permission for you to join.

How to find out more

Eleonore BOUCHEREAU, MD, PhD

e.bouchereau@ghu-paris.fr 0145658902 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.