Neurophysiological Patterns of Mindfulness Meditation for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Feasibility (i.e., subject retention at initial follow-up assessment)
研究概览
简要总结
This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 - 50 years*
- •chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency >20 minutes
- •speak and understand English
- •have a smart phone for mobile app installation
排除标准
- •sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
- •shift worker or routine night shifts
- •women with pregnancy or breast feeding
- •history of head trauma or surgery
- •regular (defined as twice a week or more) practice of mind-body interventions
- •neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
- •current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).
研究组 & 干预措施
Experimental group
Participants will utilize a daily sleep program available within a widely used smartphone app, which includes seven soundtracks (10-15min each) for guided mindfulness practice at bedtime. Techniques include breathing exercises, mental imagery, awareness of body and mind, and muscle and body relaxation.
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Feasibility (i.e., subject retention at initial follow-up assessment)
时间窗: At one month follow up visit
The primary metric for assessing Feasibility will be subject retention at the initial follow-up assessment. This includes the proportion of enrolled subjects that are active in the study at the initial follow-up assessment.
次要结局
- Acceptability(At completion of the 4 week program)
研究者
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center