The Effects of Melatonin on Sleep Spindles in Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in sleep spindle density
研究概览
简要总结
Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with ASD
- •12-18 years of age
- •English speaking
- •Able to understand and respond to questionnaires in English
排除标准
- •Pregnant or breastfeeding
- •Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
- •Chronic medical conditions that affect sleep
- •Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
- •History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
- •Other neurological disorder, including seizure disorder
- •Diagnosed sleep disorder
- •Known genetic causes of ASD
- •Currently taking melatonin or those who have had an adverse reaction to melatonin in the past
研究组 & 干预措施
Melatonin
5mg melatonin gummy 30 min before bedtime for 2 consecutive nights
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Change in sleep spindle density
时间窗: Five nights of sleep over two weeks
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.
次要结局
- Change in sleep quality(Five nights of sleep over two weeks)
研究者
Dara S. Manoach, PhD
Professor
Massachusetts General Hospital