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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Trauma, Nervous System; Brain Trauma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06766513

2024-A02567-40 (Other Identifier)

69HCL24_0936

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Patients in a vegetative state

Experimental group

Treatment:

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: Actimetry

Other: Subjective assessments

Patients in a minimally conscious state

Experimental group

Treatment:

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: questionnaire

Other: Actimetry

Other: Subjective assessments