Health TrialsbyHealthPanel

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

ConditionsTrauma, Nervous SystemBrain Trauma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Actimetry

    Other intervention

    actimetry will be performed continuously during these 104 hours.

  • Subjective assessments

    Other intervention

    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 intervention

    MOCA : Montreal Cognitive Assessment

  • questionnaire

    Other intervention

    SF-36 The Short Form (36)

  • questionnaire

    Other intervention

    CRS-R (Coma Recovery Scale-Revised)

  • questionnaire

    Other intervention

    GOSE (Glasgow Outcome Scale-Extended)

  • questionnaire

    Other intervention

    GCS (Glasgow Coma Scale)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients in a vegetative stateExperimental treatment 3 interventions
Group B: Patients in a minimally conscious stateExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique Status unavailable 69500, Bron, FranceFranceFrance

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: