EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Objective Sleepiness Scale (OSS) during extended wakefulness
研究概览
简要总结
The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness induced by sleep restriction or abnormal sleep/wake cycle). This project will allow a better understanding of the determinants of drowsiness and its impact on cognitive performance and the development of methods and models for the evaluation and prediction of cognitive performance deficit related to sleepiness. The secondary hypersomnolence will be objectified by continuous EEG recording and analysed by visual reading according to Objective Sleepiness Scale (OSS) criteria and automatically analyzed using the MEEGAWAKE algorithm (developed by PHYSIP). The level of secondary hypersomnolence will be modified by varying the duration and maintening of prior sleep or the sleep timing. The ability to stay awake will be measured by the maintenance of wakefulness test (MWT). Subjective sleepiness and mind wandering will be measured before and/or after all measurements. Simulated driving task, maintenance of wakefulness tests and several cognitive tasks to measure sustained attention, alertness, selective attention will be performed every 4 hours.
详细描述
Chronotype and general tendency to daydream in daily life will be evaluated at the inclusion visit. Healthy volunteers will be placed in sleep deprivation patterns that will modify the level of secondary hypersomnolence. These patterns correspond to sleep deprivation caused by work schedules usually observed: shift work (SDP1) or night on-call (SDP2). shift work will be simulated by total sleep deprivation for 24 hours (comparable to the first day of a night worker) followed by early morning sleep, and an extended 17 hours wakefulness (comparable to second day of night shift). Secondary hypersomnolence will be assessed throughout prolonged awakenings (24 hours + 17 hours). The night on-call will be simulated by two half-hour awakenings during the nocturnal sleep. Hypersomnolence will be measured within 17 hours of wakefulness following this sleep fragmentation. The sleep history (quantity and quality of sleep) will be evaluated by actigraphy + ambulatory polysomnography (1 day before the experiment) and 2 polysomnographies in the laboratory during the experiment. Polysomnography recordings will be visually and automatically analyzed by the ASEEGA algorithm. Ambulatory recordings are automatically analyzed by ASEEGA. Throughout these sleep deprivation patterns, electrophysiological variables (EEG, EOG and EMG) will be continuously recorded in order to identify objective drowsiness states determined visually using the OSS or automatically by the MEEGAWAKE algorithm. Subjective sleepiness scale, Mind wandering scale, maintenance of wakefulness tests (MWT, electrophysiological test) and cognitive tests will be repeated, every 4hr, throughout the sleep deprivation patterns in order to determine abilities to stay awake, driving performance, sustained and selective attention, vigilance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18 and 27,
- •With a score on the PHQ-4 scale less than or equal to 2 for scores A (Anxiety) and D (Depression),
- •Subjects with no complaints of excessive daytime sleepiness (total ESS score <11),
- •Non-professional drivers,
- •Subjects who have held their driving license for at least one year,
- •Subjects affiliated to a social security scheme,
- •Subjects able to understand the study,
- •Subjects available to come to the 3 visits required by the study,
- •Free, informed and written consent signed
排除标准
- •Pathologies that can induce excessive daytime sleepiness: untreated narcolepsy or idiopathic hypersomnia, untreated restless legs syndrome, untreated periodic leg movement syndrome,
- •Chronic insomnia disorder,
- •Excessive alcohol consumption (> 2 glasses per day) during the last 6 months,
- •Excessive consumption of coffee, tea or cola-type caffeinated beverages (> 5 cups/day),
- •Severe pathologies involving the vital prognosis in the short term,
- •Uncontrolled endocrine pathologies (dysthyroidism, diabetes),
- •All progressive cardiac pathologies, treated or untreated,
- •All progressive neurological conditions treated or not (brain tumor, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy, etc.),
- •Substance dependence,
- •Shift workers or night workers who have performed on-call or on-call duty in the last 72 hours,
- •Patients taking psychotropic drugs (antidepressants, antihistamines),
- •Long-term treatment with benzodiazepines and z-drugs,
- •Patients on cardiotropic,
- •Deprived of liberty by a judicial or administrative decision,
- •Pregnant or breastfeeding woman,
- •Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
研究组 & 干预措施
Sleep deprivation
healthy volunteers
干预措施: sleep deprivation patterns (Behavioral)
结局指标
主要结局
Change in Objective Sleepiness Scale (OSS) during extended wakefulness
时间窗: Once every 4 hours during SDP1 and SDP2 wakefulness
OSS is based on the visual analysis of electrophysiological variables (EEG (C4, O2, C3, P3), 1 vertical EOG and 1 horizontal EOG). Each state of drowsiness (score) corresponds to a specific EEG activity accompanied by well-differentiated blinking and eye movements
次要结局
- Daydreaming frequency scale(Once time during inclusion. Visit V0)
- Change in conscious experience during extended wakefulness(5 assessments every 4 hours during SDP1 and SDP2 wakefulness)
- Change in Karolinska sleepiness scale (KSS) during extended wakefulness(12 assessments every 4 hours during SDP1 and SDP2 wakefulness)
- Change in sleep onset mesured by Maintenance of Wakefulness Test (MWT) during extended wakefulness(Once every 4 hours during SDP1 and SDP2 wakefulness)
- Change in number of inappropriate line crossings (driving performance) during extended wakefulness(Once every 4 hours during SDP1 and SDP2 wakefulness)
- Munich Chorotype Questionnaire(Once time during inclusion. Visit V0)
- Horne and Ostberg morning/evening questionnaire (MEQ)(Once time during inclusion. Visit V0)
- Sleep efficiency (PSG)(2 times before SDP1 and SDP2)
- Sleep efficiency (actigraphy)(2 times before SDP1 and SDP2)
- Change in Standard deviation of the lateral position of the car (driving performance) during extended wakefulness(Once every 4 hours during SDP1 and SDP2 wakefulness)
- Change Sustained and selective attention during extended wakefulness(Once every 4 hours during SDP1 and SDP2 wakefulness)
- Total sleep time (PSG)(2 times before SDP1 and SDP2)
- Total sleep time (actigraphy)(2 times before SDP1 and SDP2)
- Change in Vigilance during extended wakefulness(Once every 4 hours during SDP1 and SDP2 wakefulness)
- Change in Simple reaction time test (PVT) during extended wakefulness(1 time every 4 hours during SDP1 and SDP2 wakefulness)
- Amount of sleep stages (PSG)(2 times before SDP1 and SDP2)
- Wake after sleep onset (actigraphy)(2 times before SDP1 and SDP2)
- Sleep onset latency (actigraphy)(2 times before SDP1 and SDP2)
- Sleep onset latency (PSG)(2 times before SDP1 and SDP2)
- Wake after sleep onset (PSG)(2 times before SDP1 and SDP2)