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临床试验/NCT00000380
NCT00000380已完成不适用

Age-Related Sleep Impairment - Treatment w/GHRH

University of Washington0 个研究点开始时间: 1996年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成

研究概览

简要总结

The purpose of this study is to examine the effects of giving growth hormone releasing hormone (GHRH) to treat sleep disorders in older men and in older women who are on estrogen replacement therapy (ERT).

Many older men and women complain of sleep disturbances. GHRH has been used successfully to treat sleep disorders in young men and may help older men and women.

40 healthy older men and 40 healthy older women on ERT will receive either GHRH or an inactive placebo.

An individual may be eligible for this study if he/she is a healthy older man or woman with sleep disturbances, and is on estrogen replacement therapy (women).

详细描述

To examine the effects of synthetic growth hormone releasing hormone (GHRH) versus placebo on the sleep quality, 24-hour secretory pattern of growth hormone (GH), and insulin-like growth factor 1 (IGF-1) concentrations of 40 healthy older men and 40 healthy older women on estrogen replacement therapy (ERT). To determine if augmenting the GH-IGF-1 axis can improve the objective sleep quality of the older population. To determine if treatment-related changes in sleep quality are correlated with changes in GH and/or IGF-1 concentrations.

Nearly 40% of the geriatric population complain of poor sleep quality, a complaint that is validated by objective findings. The physiological consequences of age-impaired sleep are poorly understood, but may include damped circadian rhythms and impaired anabolic hormone status. Poor sleep may also account for the disproportionate prescription of sedative hypnotics to older adults which may exacerbate sleep apnea, lead to daytime carryover effects such as sedation, falls, fractures, cognitive impairment, and anterograde amnesia, and has been associated with increased morbidity and mortality. The recent NIH Consensus Conference on the Treatment of Sleep Disorders in Older People concluded that nonsedative interventions to improve sleep quality in the elderly population are obviously needed. One such intervention may be stimulation of the GH-IGF-1 axis by GHRH administration. Clinical evidence indicates sleep quality can be affected by extremes of GH status and several recent studies report acute GHRH administration improves sleep quality in young men. We have recently demonstrated that measures of sleep quality correlate with basal IGF-1 concentrations in healthy older men and ERT women.

40 healthy older men and 40 healthy older women on ERT receive either GHRH or placebo.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients must have:
  • Age-related sleep impairment.
  • Estrogen replacement therapy for women.

排除标准

  • 未提供

研究组 & 干预措施

GHRH

Experimental

Growth-hormone-releasing hormone (GHRH), also known as growth-hormone-releasing factor (GRF, GHRF), somatoliberin or somatocrinin, is a releasing hormone for growth hormone.

干预措施: GHRH (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: GHRH (Drug)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vitiello

Professor, Psychiatry and Behavioral Sciences

University of Washington

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