NCT06766513

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Actimetry	actimetry will be performed continuously during these 104 hours.
OTHER	Subjective assessments	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).
OTHER	questionnaire	MOCA : Montreal Cognitive Assessment
OTHER	questionnaire	SF-36 The Short Form (36)
OTHER	questionnaire	CRS-R (Coma Recovery Scale-Revised)
OTHER	questionnaire	GOSE (Glasgow Outcome Scale-Extended)
OTHER	questionnaire	GCS (Glasgow Coma Scale)

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: France