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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02567-40 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in a vegetative state | Experimental |
| |
| Patients in a minimally conscious state | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actimetry | Other | actimetry will be performed continuously during these 104 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective assessments | during 104 consecutive hours after enrollment | |
| Actimetry | during 104 consecutive hours after enrollment |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques LUAUTE, professor | Contact | 04.78.86.51.87 | 33 | jacques.luaute@chu-lyon.fr |
| Anne-Laure CHARLOIS | Contact | anne-laure.charlois@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique | Bron, France | 69500 | France |
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| Subjective assessments | Other | 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 | Other | MOCA : Montreal Cognitive Assessment |
|
| questionnaire | Other | SF-36 The Short Form (36) |
|
| questionnaire | Other | CRS-R (Coma Recovery Scale-Revised) |
|
| questionnaire | Other | GOSE (Glasgow Outcome Scale-Extended) |
|
| questionnaire | Other | GCS (Glasgow Coma Scale) |
|
| 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 |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D000070642 | Brain Injuries, Traumatic |
| D003244 | Consciousness Disorders |
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001925 | Brain Damage, Chronic |
| D014474 | Unconsciousness |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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