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OpenTrials
Completed

NCT Number: NCT04584385

Advanced EEG Technology in Childhood Epilepsy

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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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EEG

Diagnostic Test

EEG monitoring

Primary outcomes

  1. Accuracy of seizure detection in-hospital

    Time frame: 24 hours

    Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG.

  2. Accuracy of sleep monitoring in-hospital

    Time frame: 24 hours

    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.

Secondary outcomes

  1. Accuracy of seizure detection at home

    Time frame: 1-21 days

    Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver.

  2. Accuracy of sleep monitoring at home

    Time frame: 1-21 days

    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 )

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Byteflies

Registry information

Official study title

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

Acronym: PnP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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