Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
NCT ID: NCT06766513
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-02-01
2028-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Connectivity Measurement After Severe Traumatic Brain Injury
NCT02647996
Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury
NCT06790979
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
NCT06568536
Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury
NCT02754063
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital
NCT02236676
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients in a vegetative state
Actimetry
actimetry will be performed continuously during these 104 hours.
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).
questionnaire
MOCA : Montreal Cognitive Assessment
questionnaire
SF-36 The Short Form (36)
questionnaire
CRS-R (Coma Recovery Scale-Revised)
questionnaire
GOSE (Glasgow Outcome Scale-Extended)
questionnaire
GCS (Glasgow Coma Scale)
Patients in a minimally conscious state
Actimetry
actimetry will be performed continuously during these 104 hours.
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).
questionnaire
MOCA : Montreal Cognitive Assessment
questionnaire
SF-36 The Short Form (36)
questionnaire
CRS-R (Coma Recovery Scale-Revised)
questionnaire
GOSE (Glasgow Outcome Scale-Extended)
questionnaire
GCS (Glasgow Coma Scale)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Actimetry
actimetry will be performed continuously during these 104 hours.
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).
questionnaire
MOCA : Montreal Cognitive Assessment
questionnaire
SF-36 The Short Form (36)
questionnaire
CRS-R (Coma Recovery Scale-Revised)
questionnaire
GOSE (Glasgow Outcome Scale-Extended)
questionnaire
GCS (Glasgow Coma Scale)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacques LUAUTE, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation
Florent GOBERT, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
Bron, France, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jacques LUAUTE
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-A02567-40
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL24_0936
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.