Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04584385
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-09-23
Brief Title:
Advanced EEG Technology in Childhood Epilepsy
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Advanced EEG Technology in Childhood Epilepsy A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PnP
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None