Epilepsy in ChildrenPnPNCT04584385
Advanced EEG Technology in Childhood Epilepsy
An observational study of Epilepsy in Children and Sleep Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Epilepsy in Children, Sleep Disorder
- What is being tested?
- EEG
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 8 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between 4 and 18 years old with epilepsy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
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.
Read the detailed description
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.
- Conditions
- Epilepsy in Children, Sleep Disorder
- Being tested
- EEG
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
EEG monitoring
| Study group | Role | What they receive |
|---|---|---|
| Childhood epilepsy | Children with refractory tonic, myoclonic or atonic seizures Receives: Diagnostic Test: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (2)
Accuracy of seizure detection at home
Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver.
Measured: 1-21 days
Accuracy of sleep monitoring at home
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 )
Measured: 1-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Feb 2021
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Byteflies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584385
- Sponsor's protocol ID
- s64658
- Acronym
- PnP
- Status last verified
- Jul 2024
- First submitted
- 23 Sep 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38798709
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced EEG Technology in Childhood Epilepsy: A Multimodal Wearable Approach for Long-term Seizure Detection and Sleep Monitoring.
- ClinicalTrials.gov ID
- NCT04584385
- Acronym / sponsor ID
- PnP / s64658
- Conditions
- Epilepsy in Children, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Byteflies
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childhood epilepsy | – | Diagnostic Test: EEGChildren with refractory tonic, myoclonic or atonic seizures |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between 4 and 18 years old with epilepsy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGEEG monitoring | Diagnostic test | Childhood epilepsy |
Primary outcome
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.
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.
2 secondary outcomes
Accuracy of seizure detection at home
Time frame: 1-21 days
Accuracy of sleep monitoring at home
Time frame: 1-21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 38798709Proost 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy in Children and Sleep Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of seizure detection in-hospital (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.