Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness

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.

Conditions

• Trauma, Nervous System
• Brain Trauma

Interventions

OTHER

Actimetry

actimetry will be performed continuously during these 104 hours.

OTHER

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).

OTHER

questionnaire

MOCA : Montreal Cognitive Assessment

OTHER

questionnaire

SF-36 The Short Form (36)

OTHER

questionnaire

CRS-R (Coma Recovery Scale-Revised)

OTHER

questionnaire

GOSE (Glasgow Outcome Scale-Extended)

OTHER

questionnaire

GCS (Glasgow Coma Scale)

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Principal Investigators

• Jacques LUAUTE, Professor · Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation

• Florent GOBERT, Doctor · Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2028-02-01

Completion

2028-08-01

Countries

• France