NCT00860756Unknown早期 1 期
Sleep Disturbance in Deployed Soldiers
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Actigraph and self report questionnaires
研究概览
简要总结
Hypotheses:
- Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.
- Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention group will more closely approximate normal as compared to sleep measures of Soldiers randomized to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All study participants must be on Active Duty, or be Reserve or National Guard Service Members notified of impending deployment.
- •Recruited prior to deployment in order to obtain baseline measures before deployment.
- •Have been stateside at least one full year.
- •Able to read and speak English and consent themselves.
排除标准
- •Subjects with self-identified sleep disorder (for example restless leg syndrome or sleep apnea)
- •Pregnancy. Pregnant women will be excluded from the study since pregnancy places women in a non-deployable status and pregnant Soldiers will not be deploying.
结局指标
主要结局
Actigraph and self report questionnaires
时间窗: baseline, 6 months, 18 months
次要结局
- Self report questionnaires(baseline, 6 months, 18 months)
研究者
研究点 (6)
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