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

NCT06766513 | Not Yet Recruiting

• 2 other identifiers: 69HCL24_09362024-A02567-40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Nervous System; Brain Trauma

Keywords

Traumatic brain injury; Disorders of consciousness; Vegetative State; Minimally Conscious State

Outcome Measures

Primary Outcomes (2)

• Subjective assessments

  during 104 consecutive hours after enrollment

• Actimetry

  during 104 consecutive hours after enrollment

Secondary Outcomes (12)

• Coma Recovery Scale-Revised

  once a day for 6 to 5 days

• Coma Recovery Scale-Revised

  3 months after the start of study

• Coma Recovery Scale-Revised

  6 months after the start of study

• Glasgow Coma Scale assessment

  once a day for 6 to 5 days

• Glasgow Coma Scale assessment

  3 months after the start of study

Study Arms (2)

Patients in a vegetative state

EXPERIMENTAL

Other: Actimetry; Other: Subjective assessments; Other: questionnaire

Patients in a minimally conscious state

EXPERIMENTAL

Other: Actimetry; Other: Subjective assessments; Other: questionnaire

Interventions

Actimetry OTHER

actimetry will be performed continuously during these 104 hours.

Patients in a minimally conscious state; Patients in a vegetative state

Subjective assessments OTHER

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).

Patients in a minimally conscious state; Patients in a vegetative state

questionnaire OTHER

MOCA : Montreal Cognitive Assessment

Patients in a minimally conscious state; Patients in a vegetative state

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

Bron, France, 69500, France

Location

MeSH Terms

Conditions

Trauma, Nervous System; Brain Injuries, Traumatic; Consciousness Disorders; Persistent Vegetative State

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Unconsciousness

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jacques LUAUTE, Professor

  Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation

  PRINCIPAL INVESTIGATOR

• Florent GOBERT, Doctor

  Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques LUAUTE, professor

CONTACT

04.78.86.51.87; jacques.luaute@chu-lyon.fr

Anne-Laure CHARLOIS

CONTACT

anne-laure.charlois@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

FR (1)