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| Name | Class |
|---|---|
| Byteflies | INDUSTRY |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Childhood epilepsy | Children with refractory tonic, myoclonic or atonic seizures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG | Diagnostic Test | EEG monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of seizure detection in-hospital | Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG. | 24 hours |
| Accuracy of sleep monitoring in-hospital | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of seizure detection at home | Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver. | 1-21 days |
| Accuracy of sleep monitoring at home |
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Inclusion Criteria:
Exclusion criteria
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Children between 4 and 18 years old with epilepsy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38798709 | Derived | Proost R, Heremans E, Lagae L, Van Paesschen W, De Vos M, Jansen K. Automated sleep staging on reduced channels in children with epilepsy. Front Neurol. 2024 May 10;15:1390465. doi: 10.3389/fneur.2024.1390465. eCollection 2024. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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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 )
| 1-21 days |
| D001523 | Mental Disorders |