Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Accuracy of sleep monitoring in-hospital
研究概览
简要总结
A lot of effort has already been put into the development of smaller, wearable and more user-friendly devices to monitor seizures in patients with epilepsy.
The investigators hypothesize that a wearable EEG ( in combination with additional non-EEG biosignals (motion, ECG, EMG, respiration, temperature,...) derived from Byteflies Sensor Dot and new medical patches (Plug 'n Patch system), will be able to objectively detect epileptic seizures and monitor sleep in the hospital and home environment for specific types of childhood epilepsy.
The accuracy of seizure detection and sleep monitoring by the wearable miniature EEG device in combination with other (autonomic) biosignals (full PnP system) will be compared with the golden standard video-EEG and seizure and sleep diaries filled-out by the participants.
详细描述
The objective of the study will be the following:
- Multimodal seizure detection Evaluation of data quality and seizure annotation accuracy. Comparison of data derived from the multimodal wearable device (Sensor dot in combination with Plug and Patch system) versus video EEG and seizure diary in childhood epilepsy syndromes with
- Tonic seizures
- Atonic seizures
- Myoclonic seizures During wakefulness and during sleep
- Sleep monitoring Assessment of sleep data quality, latency, sleep fragmentation and time spent in different sleep stages in different childhood epilepsy syndromes. Investigation of the influence of occuring seizures on sleep architecture.
Comparison of data wearable device (Byteflies Sensor Dot in combination with Plug and Patch system) versus video-EEG and sleep diary in childhood epilepsy syndromes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood epilepsy with tonic, atonic or myoclonic seizures
- •Parental informed consent and assent of the child if applicable
- •Parent or caregiver can keep a seizure and sleep diary reliably.
- •Exclusion criteria
- •Inability to provide written informed consent by parent or caregiver.
- •Known allergy to electrodes or medical adhesives used as part of the study protocol.
- •Having an implanted device, such as (but not limited to) a pacemaker, ICD, VNS because Sensor Dot contains magnets that could interfere with the operation of these devices.
- •Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
排除标准
- 未提供
结局指标
主要结局
Accuracy of sleep monitoring in-hospital
时间窗: 24 hours
Assessment of sleep parameters with wearable multimodal device. Comparison of data with golden standard video EEG. Sleep scoring will be done according to American Academy of Sleep Medicine.
Accuracy of seizure detection in-hospital
时间窗: 24 hours
Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG.
次要结局
- Accuracy of seizure detection at home(1-21 days)
- Accuracy of sleep monitoring at home(1-21 days)