NCT04284072: SeizeIT2

Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

Completed NA Last updated 8 November 2022

What this trial tests

NA trial testing Sensor Dot in Epilepsy in 496 participants. Completed in 30 June 2022.

Timeline

22 June 2020

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	496
Start date	22 June 2020
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	7 locations across Belgium, Sweden, United Kingdom, Germany, Portugal

Drugs / interventions tested

• Sensor Dot

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

4 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accurate detection of typical absence seizures in adults and children using a two-channel electroencephalographic wearable behind the ears.
   Swinnen L, Chatzichristos C, Jansen K, Lagae L, et al · · 2021 · cited 57× · PMID 34490891 · DOI 10.1111/epi.17061
2. The power of ECG in multimodal patient-specific seizure monitoring: Added value to an EEG-based detector using limited channels.
   Vandecasteele K, De Cooman T, Chatzichristos C, Cleeren E, et al · · 2021 · cited 38× · PMID 34240748 · DOI 10.1111/epi.16990
3. High precision in epileptic seizure self-reporting with an app diary.
   Zabler N, Swinnen L, Biondi A, Novitskaya Y, et al · · 2024 · cited 10× · PMID 38982283 · DOI 10.1038/s41598-024-66932-y
4. Classification with a Deferral Option and Low-Trust Filtering for Automated Seizure Detection.
   Becker T, Vandecasteele K, Chatzichristos C, Van Paesschen W, et al · · 2021 · cited 10× · PMID 33557034 · DOI 10.3390/s21041046
5. SeizeIT2: Wearable Dataset Of Patients With Focal Epilepsy.
   Bhagubai M, Chatzichristos C, Swinnen L, Macea J, et al · · 2025 · cited 2× · PMID 40664714 · DOI 10.1038/s41597-025-05580-x
6. Automated Sleep Staging in Epilepsy Using Deep Learning on Standard Electroencephalogram and Wearable Data.
   Macea J, Heremans ERM, Proost R, De Vos M, et al · · 2025 · cited 1× · PMID 40176726 · DOI 10.1111/jsr.70061
7. A multicenter, video-EEG-based validation of a multimodal wearable device for focal seizure detection in adults: The SeizeIT2 study.
   Swinnen L, Bhagubai M, Chatzichristos C, Weber Y, et al · · 2026 · PMID 41949013 · DOI 10.1002/epi4.70260