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Recruiting NCT06245434

Circadian Rhythmicity During Coma Awakening

Trial Parameters

Condition Acute Brain Injury Coma
Sponsor Hospices Civils de Lyon
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 17 Years
Max Age N/A
Start Date 2024-12-02
Completion 2028-12-02
Interventions
Repeated behavioural assessmentAct-Pass paradigmBiological measures of circadian and monoamines biomarkers

Brief Summary

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.

Eligibility Criteria

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 wwith 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

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