HPA AXIS/SLEEP/GCRC

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。本研究旨在探讨下丘脑-垂体肾上腺(HPA)轴活动与睡眠的关系，以及改变HPA轴的活动和节律是否有助于克服失眠。这项双盲安慰剂对照先导研究将探索米非司酮对失眠症受试者的昼夜节律和睡眠的影响，在这种情况下，通过操纵HPA轴的活动。这项研究将使用从社区或睡眠诊所招募的慢性失眠患者进行，他们表现出慢性失眠。受试者将被随机分配为每天服用安慰剂或600毫克米非司酮，为期五天。在研究开始时，大约两名受试者将被分配米非司酮开放标签作为试点试验。受试者将前瞻性地接受包括动作描记、多导睡眠图、睡眠日记和鼓室温度在内的测量，以及通过在GCRC过夜获得的治疗前和治疗后的两项激素检测。我们预计，接受米非司酮治疗的受试者最终将表现出总皮质醇水平和夜间皮质醇水平的下降。此外，我们预计皮质醇的这种下降将与睡眠效率的提高相关。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall purpose of this study is to investigate the relationships in hypothalamic-pituitary adrenal (HPA) axis activity and sleep, and to assess whether altering the HPA axis activity and rhythm can help overcome insomnia. This double-blinded placebo controlled pilot study will explore the effects of mifepristone on circadian rhythms and sleep, in this case, in subjects with insomnia, via manipulation of HPA axis activity. This study will be performed using chronic insomnia subjects recruited from the community or the sleep clinic who demonstrate chronic insomnia. The subjects will be randomly assigned to receive either placebo or 600 mg of Mifepristone daily, for five days. At the start of the study, approximately two subjects will be assigned mifepristone open-label as a pilot trial. Subjects will be prospectively followed with measures to include actigraphy, polysomnography, sleep diaries and tympanic temperature, as well as both pre-treatment and two post-treatment hormonal assays obtained via overnight stays in the GCRC. We expect that subjects treated with mifepristone will eventually demonstrate a decrease in their total and evening cortisol levels. Furthermore, we expect that such a decrease in cortisol shall correlate with an improvement in sleep efficiency.