Introducing a Structured Sleep Disruption Pattern to Provoke Earlier Seizures During Epilepsy Monitoring Unit Admissions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Seizure frequency during EMU (epilepsy monitoring unit) stay
研究概览
简要总结
Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
This is a single blind study and patients will not know which group they are in.
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 60 years
- •EMU monitoring for presurgical evaluations
- •Average 2-3 seizures per week based on pre-admission seizure diary
- •Sleep as a known seizure trigger
排除标准
- •- Multiple seizures a day based on pre-admission seizure diary
研究组 & 干预措施
Alarm
Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at 4 timepoints during the night (specific timepoints adjusted based on patient's preferred bed times). This intervention will stop when the clinical team has collected sufficient seizures for clinical decision making.
干预措施: Alarm system (Device)
Control
Patients in the control group will have an alarm system placed in their room, but the alarm system will not sound during any of the nights during their EMU admission.
结局指标
主要结局
Seizure frequency during EMU (epilepsy monitoring unit) stay
时间窗: 1 month after the EMU stay (up to 9 weeks)
Average number of seizures per day, recorded daily during the patient's EMU stay. Measured for all groups of patients.
Duration of EMU (epilepsy monitoring unit) admission
时间窗: 1 month after the EMU stay (up to 9 weeks)
Overall duration (in days) of the EMU admission. Measured for all groups of patients.
Average interictal spike rates
时间窗: 1 month after the EMU stay (up to 9 weeks)
Average number of spike rates, taken from a random segment for each day and night. Measured for all groups of patients.
Change in sleep quality
时间窗: Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)
As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances.
次要结局
未报告次要终点