Clinical trial NCT04584385: Advanced EEG Technology in Childhood Epilepsy
Official title: Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy in Children
Sleep Disorder
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Byteflies
First posted: 2020-10-14
Enrollment: 130
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 4 and 18 years old with epilepsy

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.

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.

Eligibility 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.

Primary outcomes:
measure: Accuracy of seizure detection in-hospital
timeFrame: 24 hours
measure: Accuracy of sleep monitoring in-hospital
timeFrame: 24 hours
Secondary outcomes:
measure: Accuracy of seizure detection at home
timeFrame: 1-21 days
measure: Accuracy of sleep monitoring at home
timeFrame: 1-21 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
References: