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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma, Nervous System; Brain Trauma
• Intervention / Treatment: Other: Actimetry; Other: Subjective assessments; Other: questionnaire; Other: questionnaire; Other: questionnaire; Other: questionnaire; Other: questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques LUAUTE, professor; Phone Number: 33 04.78.86.51.87; Email: jacques.luaute@chu-lyon.fr
• Study Contact Backup: Name: Anne-Laure CHARLOIS; Email: anne-laure.charlois@chu-lyon.fr

Study Locations

• France
  • Bron, France, France, 69500
    • Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
    • Contact: Jacques LUAUTE; Phone Number: +33 04.78.86.51.87; Email: jacques.luaute@chu-lyon.fr
    • Contact: Jacques LUAUTE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients in a vegetative state	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)
Experimental: Patients in a minimally conscious state	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjective assessments	during 104 consecutive hours after enrollment
Actimetry	during 104 consecutive hours after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Coma Recovery Scale-Revised	once a day for 6 to 5 days
Coma Recovery Scale-Revised	3 months after the start of study
Coma Recovery Scale-Revised	6 months after the start of study
Glasgow Coma Scale assessment	once a day for 6 to 5 days
Glasgow Coma Scale assessment	3 months after the start of study
Glasgow Coma Scale assessment	6 months after the start of study
Glasgow Outcome Scale-Extended assessment	6 months after the start of study
Glasgow Outcome Scale-Extended assessment	3 months after the start of study
Montreal Cognitive Assessment	3 months after the start of study
Montreal Cognitive Assessment	6 months after the start of study
Short Form 36 assessment	3 months after the start of the study
Short Form 36 assessment	6 months after the start of study

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jacques LUAUTE, Professor, Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation; Principal Investigator: Florent GOBERT, Doctor, Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Disorders of consciousness; Vegetative State; Minimally Conscious State
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Craniocerebral Trauma; Brain Injuries, Traumatic; Wounds and Injuries; Brain Injuries; Consciousness Disorders; Trauma, Nervous System
• Other Study ID Numbers: 69HCL24_0936; 2024-A02567-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No