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

N/ANot Yet RecruitingNCT06766513

Hospices Civils de Lyon40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Trauma, Nervous System Brain Trauma

Interventions

actimetry will be performed continuously during these 104 hours.

Subjective assessmentsOTHER

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).

questionnaireOTHER

MOCA : Montreal Cognitive Assessment

questionnaireOTHER

SF-36 The Short Form (36)

questionnaireOTHER

CRS-R (Coma Recovery Scale-Revised)

questionnaireOTHER

GOSE (Glasgow Outcome Scale-Extended)

questionnaireOTHER

GCS (Glasgow Coma Scale)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

Bron, France, France

Outcomes

Primary Outcomes

Subjective assessments

Time frame: during 104 consecutive hours after enrollment

Actimetry

Time frame: during 104 consecutive hours after enrollment

Secondary Outcomes

Coma Recovery Scale-Revised

Time frame: once a day for 6 to 5 days

Coma Recovery Scale-Revised

Time frame: 3 months after the start of study

Coma Recovery Scale-Revised