This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.
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