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临床试验/NCT01534338
NCT01534338已完成1 期

A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
48
试验地点
2
主要终点
Sleep

研究概览

简要总结

The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women (all races and ethnicities) 55 years of age and older
  • Have current problems sleeping
  • Fluent in English
  • Able to understand and provide signed informed consent
  • Willing to be randomly assigned to treatment condition

排除标准

  • Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
  • Individuals living outside of a 20 mile radius from the UCLA Medical Center
  • Individuals with current substance dependence

结局指标

主要结局

Sleep

时间窗: Within 2 weeks post-intervention

Primary sleep outcomes to be assessed include Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, Insomnia Severity Index, and Pre-Sleep Arousal Scale

次要结局

  • Mindfulness(Within 2 weeks post-intervention)
  • Inflammatory Biology(Within 2 weeks post-intervention)

研究者

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

David S. Black

Principal Investigator

University of California, Los Angeles

研究点 (2)

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