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| Name | Class |
|---|---|
| Fondation Garches | OTHER |
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After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.
After a BI , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by blue enriched withe bright light in order to improve fatigue and quality of life.
The main objective is to decrease fatigue and the secondary objectives are to improve quality of life,decrease daytime sleepiness and increase vigilance.
This is a randomized clinical trial with 2 groups blue enriched withe bright light versus nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl estimate the fatigue severity scale score , the quality of life the score (SF12), the sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will included patient with severe BI more than six months after the BI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe brain injury patient | Placebo Comparator | Severe brain injury patients with placebo |
|
| Severe brain injury patient with device | Experimental | Severe brain injury patients withe with "Luminette",Lucimed Belgium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | THIS GROUP WILL RECEIVE NO BRIGHT LIGHT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | Fatigue measure by fatigue severity scale | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth slumber scale | Subjective Slumber measured by Epworth slumber scale | 30 minutes |
| Analog visual scales | subjective slumber measured by Epworth slumber scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIA ANTONIA QUERA SALVA, MD PhD | RAYMOND POINCARE HOSPITAL | Principal Investigator |
| SARAH HARTLEY, MD | RAYMOND POINCARE HOSPITAL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Raymond Poincare | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31246878 | Derived | Quera Salva MA, Azabou E, Hartley S, Sauvagnac R, Leotard A, Vaugier I, Pradat Diehl P, Vallat-Azouvi C, Barbot F, Azouvi P. Blue-Enriched White Light Therapy Reduces Fatigue in Survivors of Severe Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E78-E85. doi: 10.1097/HTR.0000000000000500. |
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| ID | Term |
|---|---|
| D000070625 | Brain Injuries, Diffuse |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| "Luminette",Lucimed Belgium |
| Device |
THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT |
|
| 10 minutes |
| Psychomotor Vigilance Task | vigilance measured by Psychomotor Vigilance Task | 15 minutes |
| P300 | Cognitive evoked potential measure by P300 | 30 minutes |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |