UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT04584385
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.
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Notify Me4 year–18 year
All sexes
Observational
Leuven, Vlaams-Brabant, 3000, Belgium
The objective of the study will be the following:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EEG monitoring
Time frame: 24 hours
Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG.
Time frame: 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.
Time frame: 1-21 days
Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver.
Time frame: 1-21 days
Accuracy of sleep monitoring of the wearable multimodal device versus sleep checklist (Sleep Behavior Questionnaire (SQ-SP A.P.H.M. Maas, W. Braam, R. Didden, M. Smits, & L.M.G. Curfs 2005 )
Universitaire Ziekenhuizen KU Leuven
Other
Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
Acronym: PnP
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