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

Not Applicable

Not yet recruiting

• Conditions: Trauma, Nervous System; Brain Trauma

• Registration Number: NCT06766513
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-02-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective assessments	during 104 consecutive hours after enrollment
Actimetry	during 104 consecutive hours after enrollment

Secondary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised	6 months after the start of study
Glasgow Coma Scale assessment	6 months after the start of study
Glasgow Outcome Scale-Extended assessment	3 months after the start of study
Montreal Cognitive Assessment	6 months after the start of study
Short Form 36 assessment	6 months after the start of study

Trial Locations

Locations (1)

Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique; 🇫🇷 Bron, France, France