Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. Impact of Lactulose and Carnitine Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Sleep latency during Maintenance of Wakefulness Test (MWT)
研究概览
简要总结
The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.
详细描述
Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck accidents on French Freeways. Since the publication of a new law (2005 december 28th - Official Journal) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in patients suffering from hepatic encephalopathy. Furthermore, even if therapeutic drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to driving impairment. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from hepatic encephalopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis proved by histologic or clinico-biologics criteria, whatever its severity, its stability defined by a child stable score (variation < 2 points for the last month) without any other disease which could be responsible of excessive daytime sleepiness
- •driver's licence since at least 2 years
- •driving more than 2000 Km/year
- •registered to French national health and pensions organization
- •having given their written light agreement in order to participate in the study.
排除标准
- •Night workers
- •neurologic disease
- •recent strong complication (< 30 days)
- •recent antibiotics or lactulose intake
- •substance abusers (alcohol)
- •hepatoma more than 5 cm
- •disorder associated which engaged life prognostic in a short time
- •glycemia fasted > 8 mmol/l
- •haemoglobin < 10g/l
- •neurologic or psychiatric disorders associated which affect superiors functions,
- •hepatic encephalopathy stage 3 or 4
- •having participated in a clinical study during the last 6 months
- •drugs abusers
- •unable to drive.
研究组 & 干预措施
Carnitine
Versus placebo.
干预措施: L-carnitine (Drug)
Lactulose
Versus placebo
干预措施: Lactulose (Drug)
结局指标
主要结局
Sleep latency during Maintenance of Wakefulness Test (MWT)
时间窗: 40 min
次要结局
- Nocturnal sleep quality and quantity will be measured by Polysomnography (PSG).(1 night)
- Nocturnal sleep quality and quantity measured by Actimetry.(during 3 days)