Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Subjective Sleep Times
研究概览
简要总结
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •Male gender
- •veteran of OIF/OEF
- •comorbid mental health problems such as depression, anxiety are allowed
- •self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares.
- •sleep disturbances must have started after a deployment
排除标准
- •Axis I mental disorders incompatible with active military service
- •History of moderate to severe traumatic brain injury
- •Sleep Apnea
- •Current use of Continuous Positive Airway Pressure Devices
- •Significant Co-morbid conditions (heart, lung, liver disease, etc.)
- •Other treatment programs that involve cognitive processing therapy
- •No concurrent use of acupuncture during study
- •taking any anticoagulation medication
- •essential tremors
结局指标
主要结局
Change in Subjective Sleep Times
时间窗: Baseline (upon entering study) and at one month
Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month
Change in Objective Sleep Times
时间窗: Baseline (upon entering study) and at one month
Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month.
Acceptability of Acupuncture as a Treatment for Sleep Disturbance
时间窗: One month
Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question.
次要结局
- Change in Post Traumatic Stress Disorder Symptoms(Baseline (upon enterning the study) and week 3 & at week 5)
- Change in Depression(Baseline (upon entering study) and at week 3 & at week 5)
- Change in Sleep Quality(Baseline (upon entering study) and at one month)