HPA AXIS/SLEEP/GCRC

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的总体目的是探讨下丘脑-垂体-肾上腺（HPA）轴活动与睡眠的关系，并评估改变HPA轴活动和节律是否有助于克服失眠。 这项双盲安慰剂对照的初步研究将探索米非司酮对昼夜节律和睡眠的影响，在这种情况下，在失眠症患者中，通过操纵HPA轴活动。 本研究将使用从社区或睡眠诊所招募的表现出慢性失眠的慢性失眠受试者进行。 受试者将被随机分配接受安慰剂或米非司酮600毫克，每天五天。 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。 将对受试者进行前瞻性随访，测量包括体动记录仪、多导睡眠图、睡眠日记和鼓膜温度，以及通过在GCRC过夜获得的治疗前和两次治疗后激素测定。我们预计，米非司酮治疗的受试者最终将显示其总皮质醇水平和夜间皮质醇水平下降。 此外，我们预计皮质醇的这种减少应与睡眠效率的改善相关。

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.