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NCT Number: NCT06766513

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

Bron, France, 69500, France

Location contact

Jacques LUAUTE

CONTACT

[email protected]

04.78.86.51.87 ext. +33

Jacques LUAUTE

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actimetry

Other

actimetry will be performed continuously during these 104 hours.

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).

Questionnaire

Other

MOCA : Montreal Cognitive Assessment

Primary outcomes

  1. Subjective assessments

    Time frame: during 104 consecutive hours after enrollment

  2. Actimetry

    Time frame: during 104 consecutive hours after enrollment

Secondary outcomes

  1. Coma Recovery Scale-Revised

    Time frame: once a day for 6 to 5 days

  2. Coma Recovery Scale-Revised

    Time frame: 3 months after the start of study

  3. Coma Recovery Scale-Revised

    Time frame: 6 months after the start of study

  4. Glasgow Coma Scale assessment

    Time frame: once a day for 6 to 5 days

  5. Glasgow Coma Scale assessment

    Time frame: 3 months after the start of study

  6. Glasgow Coma Scale assessment

    Time frame: 6 months after the start of study

  7. Glasgow Outcome Scale-Extended assessment

    Time frame: 6 months after the start of study

  8. Glasgow Outcome Scale-Extended assessment

    Time frame: 3 months after the start of study

  9. Montreal Cognitive Assessment

    Time frame: 3 months after the start of study

  10. Montreal Cognitive Assessment

    Time frame: 6 months after the start of study

  11. Short Form 36 assessment

    Time frame: 3 months after the start of the study

  12. Short Form 36 assessment

    Time frame: 6 months after the start of study

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Laure CHARLOIS

CONTACT

[email protected]

Jacques LUAUTE, professor

CONTACT

[email protected]

04.78.86.51.87 ext. 33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SLEEPDOC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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