跳至主要内容
临床试验/NCT03578003
NCT03578003招募中不适用

Morning Bright Light to Improve Sleep Quality in Veterans

Portland VA Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Change in Insomnia Severity Index (ISI)

研究概览

简要总结

One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • History of bipolar disorder
  • History of macular degeneration
  • Non-English speaking
  • Decisionally impaired
  • Currently using a light box

结局指标

主要结局

Change in Insomnia Severity Index (ISI)

时间窗: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention

Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)

次要结局

未报告次要终点

研究者

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

Miranda M Lim

Staff Physician and Assistant Professor

Portland VA Medical Center

研究点 (2)

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