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Not yet recruiting NCT06766513

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

No phase Interventional Trauma, Nervous System Brain Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Actimetry, Subjective assessments, questionnaire, questionnaire.
Who it may be relevant to
Registry conditions: Trauma, Nervous System, Brain Trauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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)

Primary outcome measures

  • Subjective assessments [Time frame: during 104 consecutive hours after enrollment]
  • Actimetry [Time frame: during 104 consecutive hours after enrollment]
Secondary outcome measures (12)
  • 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 [Time frame: 6 months after the start of study]
  • Glasgow Coma Scale assessment [Time frame: once a day for 6 to 5 days]
  • Glasgow Coma Scale assessment [Time frame: 3 months after the start of study]
  • Glasgow Coma Scale assessment [Time frame: 6 months after the start of study]
  • Glasgow Outcome Scale-Extended assessment [Time frame: 6 months after the start of study]
  • Glasgow Outcome Scale-Extended assessment [Time frame: 3 months after the start of study]
  • Montreal Cognitive Assessment [Time frame: 3 months after the start of study]
  • Montreal Cognitive Assessment [Time frame: 6 months after the start of study]
  • Short Form 36 assessment [Time frame: 3 months after the start of the study]
  • Short Form 36 assessment [Time frame: 6 months after the start of study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique — Bron, France

Identifiers

NCT: NCT06766513 · 69HCL24_0936 · 2024-A02567-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗