Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Interictal Discharge frequency
研究概览
简要总结
The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression
详细描述
- To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
- To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
- To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years old
- •Able to provide informed consent
- •Fluent in English
- •Frequent nocturnal IEDs (≥ 10% of the sleep record)
- •Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
- •Frequent nocturnal seizures (≥1 per week)
排除标准
- •Hearing impairment
- •Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
- •Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
- •Seizures ≤ 24 hours prior to study.
- •Alcohol or recreational drug use in the 24 hours prior to the study
- •MOCA <26
- •History of recent travel across time zones within the 1 month prior to study activities
- •Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
- •No medication changes at least 1 month before study, and during 3 months of study activities
结局指标
主要结局
Interictal Discharge frequency
时间窗: 72 hours
IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
Successful System Training
时间窗: 72 hours
Assessment of how well participants learn to use stimulation smart-phone application and headphones, defined as the percentage of subjects with correctly maintained earphones during the first four hours of nocturnal sleep in the first days of use.
System Adherence
时间窗: 2 months
Percentage of nights during which patients were compliant with the acoustic stimulation device during two months of home use (1 month control acoustic condition, 1 month 1Hz stimulation) determined weekly by patient self-report
次要结局
- System Use effect on Features of Sleep(72 hours)
- Seizure Control(3 months)