Clinical trial NCT06766513: Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
Official title: Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma, Nervous System
Brain Trauma
Keywords: Traumatic brain injury
Disorders of consciousness
Vegetative State
Minimally Conscious State
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.


Eligibility criteria: Inclusion Criteria:

* Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit
* Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)
* Traumatic brain injury
* Patient aged 18 years or older
* Presence of relatives able to express non-opposition to the study
* Subjects affiliated with a social security scheme (or beneficiaries)

Exclusion Criteria:

* Admission for status epilepticus
* Individuals admitted to a healthcare or social care facility for purposes other than research
* Adults under legal protection measures (guardianship, conservatorship)
* Individuals not affiliated with a social security scheme or not benefiting from a similar scheme

Primary outcomes:
measure: Subjective assessments
timeFrame: during 104 consecutive hours after enrollment
measure: Actimetry
timeFrame: during 104 consecutive hours after enrollment
Secondary outcomes:
measure: Coma Recovery Scale-Revised
timeFrame: once a day for 6 to 5 days
measure: Coma Recovery Scale-Revised
timeFrame: 3 months after the start of study
measure: Coma Recovery Scale-Revised
timeFrame: 6 months after the start of study
measure: Glasgow Coma Scale assessment
timeFrame: once a day for 6 to 5 days
measure: Glasgow Coma Scale assessment
timeFrame: 3 months after the start of study
measure: Glasgow Coma Scale assessment
timeFrame: 6 months after the start of study
measure: Glasgow Outcome Scale-Extended assessment
timeFrame: 6 months after the start of study
measure: Glasgow Outcome Scale-Extended assessment
timeFrame: 3 months after the start of study
measure: Montreal Cognitive Assessment
timeFrame: 3 months after the start of study
measure: Montreal Cognitive Assessment
timeFrame: 6 months after the start of study
measure: Short Form 36 assessment
timeFrame: 3 months after the start of the study
measure: Short Form 36 assessment
timeFrame: 6 months after the start of study
Other outcomes:
Locations:
city: Bron, France
country: France
facility: Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
Study officials:
affiliation: Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation
name: Jacques LUAUTE, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
name: Florent GOBERT, Doctor
role: PRINCIPAL_INVESTIGATOR
References: