Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Spike wave index
研究概览
简要总结
Background: Close relationship exists between sleep slow wave (SSW) and the generation of spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between excitatory depolarization ("Up-phase" of the SSW) and inhibitory hyperpolarization ("Down-phase" of the SSW). It has been shown experimentally that with increasing synchrony of slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in correspondence to the SSW "Up-phase" enhance the amplitude of the subsequent SSW. Conversely, tones delivered at the SSW "Downphase" have a disruptive effect on the following SSW.
Participants: Patients with epilepsy and spike waves in NREM-sleep.
Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by acoustic pulses applied at the "Up-" or "Down-phase" of SSW.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Rolandic epilepsy/BECTS
- •Participants with ESES/CSWS
- •Participants with generalized spike waves in sleep
- •EEG within 6 months before study night consistent with the diagnosis
排除标准
- •Clinically significant concomitant acute or chronic disease
- •Seizure frequency >1/week, history of convulsive status epilepticus or seizures provoked by sleep deprivation
- •Severe sleep problems
- •Treatment with corticosteroids, immunosuppressive or vagus nerve stimulation
结局指标
主要结局
Spike wave index
时间窗: Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Change of spike wave index during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spike wave index given in percent and calculated by number of seconds within 10 second windows with spike waves over the whole 15 minutes of the block design part.
次要结局
- Spike wave spreading(Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes)
- Spike wave amplitude in the NREM (2) period following the NREM (1) period with acoustic pulses(Change baseline (NREM 1) and NREM 2: expected average of 1 hour)
- Spike wave amplitude(Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes)
- Spike wave index in the NREM (2) period following the NREM (1) period with acoustic pulses(Change baseline (NREM 1) and NREM 2: expected average of 1 hour)
- Spike wave spreading in the NREM (2) period following the NREM (1) period with acoustic pulses(Change baseline (NREM 1) and NREM 2: expected average of 1 hour)