Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe brain injury patients more than 6 months after the trauma
- •Out of the phase of post-traumatic amnesia (score in Galveston Orientation and Amnesia Test (GOAT) upper to 75)
- •Initial score on the Glasgow coma scale inferior or equal to 8 within the first 24 hours after brain injury, except sedation
- •Age from 18 to 65 years old
- •Fatigue severity score ( FSS) superior or equal to 4 and/or a score on the sleepiness Epworth scale superior or equal to 10 and/or a score to the quality questionnaire of sleep of Pittsburg > in 5
- •Having given a writing informed consent
- •Registered on the Social Security
排除标准
- •Non-stabilized psychiatric neurological affection and/or endocrine diseases or drug addiction
- •Major depression diagnosed with the "MINI" depression scale
- •Cognitive, behavioural or motor disorders incompatible with use of phototherapy glasses
- •Night workers or transméridien journey in the last month
- •Chronic fatigue syndrome before the accident
- •Major obesity (BMI > 33)
- •High risk of apnea syndrome in the Berlin questionnaire
- •Consumption of long half-l hypnotics or stimulants
- •Treatments with antidepressants are tolerated if the dose is stable during all the participation on approval and for at least one month before the inclusion.
- •Eye lesion, in particular of the retina
- •Photosensibility
结局指标
主要结局
Fatigue Severity Scale
时间窗: 30 minutes
Fatigue measure by fatigue severity scale
次要结局
- Analog visual scales(10 minutes)
- Epworth slumber scale(30 minutes)
- Psychomotor Vigilance Task(15 minutes)
- P300(30 minutes)