Advanced EEG Technology in Childhood Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-03-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Epilepsy in Children Sleep Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Childhood epilepsy

Children with refractory tonic, myoclonic or atonic seizures

EEG

Intervention Type DIAGNOSTIC_TEST

EEG monitoring

Interventions

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EEG

EEG monitoring

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No