Advanced EEG Technology in Childhood Epilepsy (PnP)

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Sleep Disorder

Epilepsy in Children

Treatments

Diagnostic Test: EEG

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04584385

s64658

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.