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临床试验/NCT00319371
NCT00319371已完成不适用

Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1

研究概览

简要总结

We study the skin-temperature (skin temperature measurement on different skin regions) and circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.

This project will provide further information at which circadian phase vasospasms occur in daily routine life (one week recordings). Special interest lays on the time before sleep. The attained results could be used to establish a therapy with few side effects for people with difficulties initiating sleep because of vasospasm.

详细描述

We study the skin-temperature and circadian rest-activity cycles of 40 women in their daily life.

20 women with vasospasm and difficulties of initiating sleep and 20 women without vasospasm and no difficulties of initiating sleep.

Women without contraceptives will be examined in the luteal phase (i.e. in the two weeks before menstruation). The ambulant registry will be done continuously during one week with so called i-Buttons (IButtonTM, Maxim, USA). These will be fixed to various parts of the body (i.e. wrist, ankle, ...) with Fixomull, a medical bond. Also the subjects have to wear a instrument for registration activity, the so called Actiwatch (Cambridge, UK). The data that will be gained from these instruments, shall help us to objectify sleep-latency and sleep-fragmentation ("sleeping-through").

Furthermore, the subjects obtain a sleep-and activity-dairy, that has to be filled before and after sleeping. At one day, that the proband can choose, saliva samples have to be taken by the subjects themselves. In the saliva, the concentration of melatonin will be qualified. The attained results could be used to establish a therapy with few side effects for people with difficulties of initiating sleep because of vasospasm.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Subjects have to show a vasospasm and difficulties of initiating sleep (screening with questionnaires and interview)
  • Controls have to show no vasospasm and no difficulties of initiating sleep (screening with questionnaires and interview)

排除标准

  • bad health or unhealthy conditions
  • allergies (i.e. nickel)
  • medication
  • delayed sleep phase syndrome
  • advanced sleep phase syndrome
  • alcohol- or drug problems
  • blood donation in last three months before study
  • participation at an other clinical study in last three months before study
  • shift work in last three months before study
  • long-distance flight (> 2 time zones) in last month before study

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other

研究点 (1)

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