Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Polysomnography
研究概览
简要总结
People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.
详细描述
People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.
Prior to the cross-over study described here, a dosing study will be completed. Twenty Veterans with PTSD with or without history of mTBI, assessed for inclusion and exclusion per protocol, will be evaluated over three polysomnography nights with at least a one week washout period. Pseudo-randomly distributed across the three nights, each participant will be tested on three of the 10 parameters, creating a total of 60 testing sessions (6 for each parameter setting with each represented twice in each night slot). primary sleep architecture variables (slow wave sleep time, REM sleep time) and autonomic responses will be used as outcomes. The optimal dose will be selected and the study will proceed to the cross-over design phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
- •English fluency
排除标准
- •Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
- •Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the
- •e.g., schizophrenia
- •Untreated sleep apnea
- •CPAP controlled sleep apnea is okay
- •Major uncorrected sensory deficit
- •Current drug or alcohol abuse
- •Drug abuse within the last two months will result in exclusion or delay
- •Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
- •No pregnancy
研究组 & 干预措施
non-invasive nerve stimulation a
Electrical stimulation will be delivered to a location at the ear.
干预措施: non-invasive nerve stimulation (Device)
non-invasive nerve stimulation b
Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly.
干预措施: non-invasive nerve stimulation (Device)
结局指标
主要结局
Polysomnography
时间窗: One night comparison
Polysomnography measures. Slow wave sleep time. Rem sleep time.
次要结局
未报告次要终点