Advanced EEG Technology in Childhood Epilepsy

Sleep Disorder Clinical Trial

— PnP  

Official title:

Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584385
• Other study ID #: s64658
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Katrien Jansen, MD, PhD
• Phone: +3216343845
• Email: katrien.jansen[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy in Children
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• EEG
EEG monitoring

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Byteflies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of seizure detection in-hospital	Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG.	24 hours
Primary	Accuracy of sleep monitoring in-hospital	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.	24 hours
Secondary	Accuracy of seizure detection at home	Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver.	1-21 days
Secondary	Accuracy of sleep monitoring at home	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 )	1-21 days