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Clinical Trial Summary

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.


Clinical Trial Description

The objective of the study will be the following: 1. 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 2. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04584385
Study type Observational
Source Universitaire Ziekenhuizen Leuven
Contact Katrien Jansen, MD, PhD
Phone +3216343845
Email katrien.jansen@uzleuven.be
Status Recruiting
Phase
Start date February 1, 2021
Completion date February 1, 2025

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