Trials / Completed
CompletedNCT04584385
Advanced EEG Technology in Childhood Epilepsy
Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 4 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EEG | EEG monitoring |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2023-03-08
- Completion
- 2023-03-08
- First posted
- 2020-10-14
- Last updated
- 2024-07-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04584385. Inclusion in this directory is not an endorsement.