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Could body clocks predict coma recovery?

NCT ID NCT06245434

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tracks 90 coma patients in intensive care to see if their body's natural daily rhythms (like sleep-wake cycles) return as they wake up. Researchers will measure behavior, eye movements, temperature, and urine biomarkers every few hours. The goal is to better understand how consciousness returns, which could lead to better ways to predict recovery and select patients for future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict when a patient might wake from a coma and identify biological markers for future coma treatments.
What could go wrong
This is an early observational study with only 90 participants. It is not testing a treatment, so it may not directly lead to new therapies. Results may not apply to all coma patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

17 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Group 1 * Admission to the Neurological Intensive Care Unit * Initial disorder of consciousness (GCS \< 8) or initial brain lesion (on CT or MRI) requiring intubation and sedation during management (for upper airway protection or due to coma) * Intubated patient under mechanical ventilation with no response to simple commands * Weaning from sedation : acquired / possible within 7 days of inclusion in the absence of new complications * Severity of clinical or morphological impairment leading to risk of persistent disturbance of consciousness * Sedation discontinued or able to be discontinued within 3 month of initial management of the disorder of consciousness or brain injury * Effective treatment of the cause of admission without risk of short-term recurrence * Patient aged 17 or over * Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1 * Presence of relatives able to sign consent or of the minor's legal representative Group 2 * Admission to the Neurological Intensive Care Unit or the Neurological Continuing Care Unit * Absence of severe disorder of consciousness but possibility of minimal alteration of the initial Glasgow score (GCS between 9 and 15) with no time limit, with a stratification of three consecutive patient populations distinguished by the initial neurological alteration: * GCS = 15 * GCS \< 15 by predominance of an initial defect in responses to simple or complex commands obtained by motor or verbal means, without abnormality of arousal (E score = 4 but M score \< 6 and/or V score \< 5) * GCS \< 15 with predominant initial somnolence, with or without abnormal motor or verbal responses to simple or complex commands (E score = 2 or 3 but M score = 6 and/or V score = 5). * Existence of functional communication or functional use of objects at inclusion * Mechanism of injury for which the aetiology is no longer active or at risk of recurrence * Patient aged 17 or over * Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1 * In the case of impaired judgement despite functional communication or in the case of aphasia with functional use of objects: presence of relatives able to sign consent or of the legal representative of the minor or of the legal representative of the protected adult. Group 3 * Admission to the Adult Post-Resuscitation Rehabilitation Department, in the Neurological Multidisciplinary Intensive Care Unit * Disturbance of consciousness defined by an absence of communication or an absence of functional use of objects (for patients with aphasia), i.e. the two signs that could indicate emergence from the pauci-relational state, which includes patients presenting : * persistent coma * a vegetative state (or unresponsive wakefulness syndrome) * a pauci-relational state (MCS- or MCS+ if responding to simple commands). * Persistent within the following timeframe * More than 3 months after the initial management of the disorder of consciousness or brain injury * More than 1 month after a post-anoxic coma. * Mechanism of injury for which the aetiology is no longer active or at risk of recurrence * Patient aged 17 or over * Presence of relatives likely to sign the consent or of the legal representative of a minor or of the legal representative of a protected adult Exclusion Criteria: Group 1 * Subjects with a contraindication to MRI scans * Admission for status epilepticus * Existence of status epilepticus during the stay and persisting for \> 24h or presenting an electrical remission for less than 48h prior to inclusion * Post-anoxic coma with bilateral abolition of N20 PES cortical responses * Coma related to a potentially recurrent cause of coma (tumours, infectious diseases with risk of relapse and inflammatory diseases) * Moribund patient (life expectancy \< 24h) or in WLST (no assessment possible of the dynamics of ongoing awakening) * Haemodynamic or respiratory instability incompatible with a prolonged attempt to stop sedation (except in the case of scheduled surgery outside the visit dates) * Patients under guardianship, curatorship or safeguard of justice * Patients not affiliated to the French health insurance system * Pregnant women or women of childbearing age without proof of the absence of a current pregnancy Group 2 * Subjects with a contraindication to MRI scans * Epileptic seizures on admission or during the stay * Single seizure: if no rapid return to consciousness (GCS \< 8 for \> 12 hours) * \> 2 distinct epileptic seizures regardless of the duration of loss of consciousness * Status epilepticus * Post-anoxic coma with bilateral abolition of N20 cortical PES responses. * Coma linked to a potentially recurrent cause of coma (tumour, infection with risk of relapse and inflammation). * A moribund patient (life expectancy \< 24 hours) or a patient undergoing WLST with a high risk of death before the end of the study (inclusion possible if no therapeutic escalation is decided in a stabilised patient). * Haemodynamic or respiratory instability incompatible with prolonged evaluation of the absence of sedation (risk of general anaesthesia for further failure, except in the case of scheduled surgery outside the visit dates). * Patients under guardianship, curatorship or safeguard of justice * Patients not affiliated to the French health insurance system * Pregnant women or women of childbearing age without proof of the absence of a current pregnancy Group 3 * Subjects with a contraindication to MRI scans * Epileptic seizures during the week preceding inclusion: * Single seizure: if no rapid return to usual state of consciousness for \> 12 hours * \> 2 separate comitial seizures regardless of duration of loss of consciousness * Epileptic malaise * Post-anoxic coma with bilateral abolition of N20 cortical responses to SEP * Coma related to a potentially recurrent cause of coma (tumour, infection with risk of relapse and inflammation) * Moribund patients (life expectancy \< 24 hours) or patients undergoing WSLT with a high risk of death before the end of the study (inclusion possible if no therapeutic escalation is decided in a stabilised patient). * Haemodynamic or respiratory instability incompatible with prolonged evaluation of the absence of sedation (risk of general anaesthesia for further failure, except in the case of scheduled surgery outside the visit dates). * Patients under guardianship, curatorship or safeguard of justice prior to the event that provoked their state of chronic disturbance of consciousness. Patients under guardianship because of their chronic disorder of consciousness are eligible for the study. * Patients not affiliated to the French health insurance system * Pregnant women or women of childbearing age without proof of the absence of a current pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer

    RECRUITING

    Bron, Lyon, 69500, France

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