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临床试验/NCT03153917
NCT03153917已完成不适用

Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
total amount of melatonin excreted during the sleep period for the night shift

研究概览

简要总结

Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Nurses or nursing assistants working in the Sleep and Respiratory Diseases Department of the Croix-Rousse Hospital with positions in 12 hours for more than 6 months
  • informed consent given by the subject

排除标准

  • Pregnancy or lactation <6 months
  • Taking treatment modifying the secretion of melatonin (melatoninergic drugs (including antidepressants), beta-blockers)
  • Refusal of participate
  • Minor or major protected subject
  • Not affiliated to a social security scheme
  • Participant in another interventional study interfering with sleep / wake rhythm or work schedules (judgment of the investigator)

研究组 & 干预措施

melatonin and cortisol sampling

Experimental

14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon.

干预措施: melatonin and cortisol sampling (Other)

结局指标

主要结局

total amount of melatonin excreted during the sleep period for the night shift

时间窗: at day 8 (night shift)

The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition

total amount of melatonin excreted during the sleep period for the day shift.

时间窗: at day 2 (day shift)

The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition

次要结局

  • Insomnia severity(at day 1)
  • Chronotype(at day 1)
  • Sleep subjective quality(at day 2, 8 and 13)
  • Light exposition(15 days)
  • Total amount of melatonin excreted during the sleep period at rest(at day 13 (rest))
  • Asthenia(at day 1)
  • Objective sleep duration(15 days)
  • Excessive daytime sleepiness(at day 1)
  • Anxiety(at day 1)
  • Depression(at day 1)
  • Vigilance at awakening(at day 2, 8 and 13)
  • Cortisol secretion dynamics in 12h day shift(at day 2 (day shift))
  • Cortisol secretion dynamics in 12h night shift(at day 8 (night shift))
  • Cortisol secretion dynamics at rest(at day 13 (rest))
  • Objective sleep quality(15 days)
  • Melatonin secretion dynamics in 12h day shift(at day 2 (day shift))
  • Melatonin secretion dynamics in 12h night shift(at day 8 (night shift))
  • Melatonin secretion dynamics at rest(at day 13 (rest))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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