Trauma, Nervous System, Brain Trauma
Conditions
Keywords
Traumatic brain injury, Disorders of consciousness, Vegetative State, Minimally Conscious State
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.
Interventions
OTHERActimetry
actimetry will be performed continuously during these 104 hours.
OTHERSubjective assessments
The subjective assessments of the patient's awake/sleep state will be collected every 2 hours during the night and at least 3 times during the day, for a total of at least 8 assessments per 24-hour period, over a duration of 104 consecutive hours (slightly more than 4 days, starting at midnight and ending at 8 :00 AM, to cover 4 full days and 4 full nights).
OTHERquestionnaire
MOCA : Montreal Cognitive Assessment
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective assessments | during 104 consecutive hours after enrollment |
| Actimetry | during 104 consecutive hours after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale-Extended assessment | 6 months after the start of study |
| Coma Recovery Scale-Revised | once a day for 6 to 5 days |
| Short Form 36 assessment | 3 months after the start of the study |
| Montreal Cognitive Assessment | 3 months after the start of study |
| Glasgow Coma Scale assessment | once a day for 6 to 5 days |
Countries
France
Contacts
Primary ContactJacques LUAUTE, professor
Backup ContactAnne-Laure CHARLOIS
Outcome results
None listed