Actively Recruiting

Phase Not Applicable
Age: 17Years +
All Genders
NCT06245434

Circadian Rhythmicity During Coma Awakening

Led by Hospices Civils de Lyon · Updated on 2026-02-06

90

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute brain injury is a major cause of admission to intensive care units, as well as of mortality and morbidity, worldwide and for all age groups. With most patients surviving these injuries thanks to recent medical advances, society is facing not only the growing burden of disability, but above all the ethical issues involved in withdrawal of life-sustaining therapies (WSLT). To resolve this dilemma, effective treatment would be necessary, but this is hampered by our limited knowledge of the pathophysiological mechanisms of the natural history of coma, from onset to recovery. A more systematic description of coma awakening using a multimodal battery in intensive care unit patients would enable us to refine the awakening and re-emergence of consciousness and define appropriate biomarkers for selecting candidates in interventional studies. The investigators hypothesize that the current postulate of successive stages (i.e. from one clinical class to the next) of coma recovery is incomplete, as it does not take into account the rhythmic nature of wakefulness. The investigators propose that the best correlate of the natural history of coma recovery is a gradual shift from the loss of physiological cycles to a circadian rhythmicity of arousal indices (behavioural and neurophysiological) and a wide amplitude of metric fluctuations in assessing content richness.

CONDITIONS

Official Title

Circadian Rhythmicity During Coma Awakening

Who Can Participate

Age: 17Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to the Neurological Intensive Care Unit
  • Initial disorder of consciousness (Glasgow Coma Score less than 8) or brain lesion requiring intubation and sedation
  • Intubated patient under mechanical ventilation with no response to simple commands
  • Weaning from sedation possible within 7 days of inclusion without new complications
  • Severity of impairment risking persistent consciousness disturbance
  • Sedation discontinued or able to be discontinued within 3 months of initial management
  • Effective treatment of admission cause without short-term recurrence risk
  • Patient aged 17 or older
  • Urinary catheter in place at inclusion and remains until first visit
  • Presence of relatives able to sign consent or legal representative if minor
  • Admission to Neurological Intensive or Continuing Care Unit
  • Glasgow Coma Score between 9 and 15 with possible minimal alteration
  • Functional communication or use of objects at inclusion
  • Mechanism of injury no longer active or at risk of recurrence
  • Admission to Adult Post-Resuscitation Rehabilitation or Neurological Multidisciplinary Intensive Care Unit
  • Disturbance of consciousness including coma, vegetative state, or minimally conscious state
  • Persistent disturbance more than 3 months after initial management or more than 1 month after post-anoxic coma
  • Presence of relatives or legal representatives able to consent
Not Eligible

You will not qualify if you...

  • Contraindication to MRI scans
  • Admission for status epilepticus or status epilepticus lasting more than 24 hours
  • Post-anoxic coma with bilateral abolition of N20 cortical responses
  • Coma due to recurrent causes like tumors, infections with relapse risk, or inflammatory diseases
  • Moribund patients with life expectancy less than 24 hours or undergoing withdrawal of life-sustaining therapies
  • Hemodynamic or respiratory instability incompatible with sedation withdrawal
  • Patients under guardianship, curatorship, or safeguard of justice
  • Patients not affiliated with the French health insurance system
  • Pregnant women or women of childbearing age without proof of no current pregnancy
  • Epileptic seizures on admission or during stay with certain severity criteria
  • Epileptic seizures within one week before inclusion for rehabilitation patients
  • Guardianship due to chronic disorder of consciousness prior to event (except eligible for chronic condition)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service de Réanimation Polyvalente Neurologique Hôpital Neurologique Pierre Wertheimer

Bron, Lyon, France, 69500

Actively Recruiting

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Research Team

G

GOBERT FLORENT, M.D. Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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