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临床试验/NCT00282061
NCT00282061Unknown1 期

Synchronization and Desynchronization Between Circadian Rhythms in Patients With Delayed Sleep Phase Syndrome (DSPS)

Sheba Medical Center2 个研究点 分布在 1 个国家开始时间: 2006年1月25日最近更新:
适应症
相关药物

试验速览

阶段
1 期
试验地点
2

研究概览

简要总结

This study's first aim is to widen the knowledge of the characteristics of delayed sleep phase disorder (DSPS) by focusing on the circadian rhythms of appetite regulation factors and their phase relations to the cycles of sleep-wake, melatonin, cortisol and body temperature. This study's second aim is to assess the influence of forced morning awakening, as a daily struggle faced by DSPS patients, upon the synchronization of these variables in DSPS patients. The investigators hypothesize that the chronic incompatibility between the endogenous sleep-wake rhythm of the DSPS patients and the morning wakefulness, as a social demand, may impair the synchronization between the different rhythms, as findings indicate in normal subjects under jet lag. And finally, the third aim of the study is to assess the influence of successful treatment with melatonin upon the phase locations of circadian rhythms of studied measures and the synchronization between them. These measures will be assessed in a controlled study, for 36 hours (sampled every 2 hours) under three distinct experimental conditions: first, under free sleep-wake conditions (ad-libitum bedtime and arousal); second, under restricted sleep-wake conditions (enforced morning wake-up); and finally, after 12 weeks of melatonin treatment.

详细描述

Method:

Subjects:

A total of 20 subjects, 10 diagnosed as DSPS patients and 10 matched healthy controls with a proven normal sleep-wake cycle.

Exclusion criteria for the recruitment would be body mass index (BMI) higher than 28 or lower than 22, shift-work, or chronic disease and chronic medication use.

Procedure:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Ect
盲法
None

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of DSPS

排除标准

  • BMI higher than 28 or lower than 22
  • Shift-work
  • Chronic disease and chronic medication use

研究者

申办方类型
Other Gov

研究点 (2)

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