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Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
Sponsor: Hospices Civils de Lyon
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-02-01
Completion Date
2028-08-01
Last Updated
2025-01-09
Healthy Volunteers
No
Conditions
Interventions
Actimetry
actimetry will be performed continuously during these 104 hours.
Subjective 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).
questionnaire
MOCA : Montreal Cognitive Assessment
questionnaire
SF-36 The Short Form (36)
questionnaire
CRS-R (Coma Recovery Scale-Revised)
questionnaire
GOSE (Glasgow Outcome Scale-Extended)
questionnaire
GCS (Glasgow Coma Scale)
Locations (1)
Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
Bron, France, France