SeizeIT2
Research type
Research Study
Full title
A multi-centre study to examine clinical scenarios for long-term monitoring of epileptic seizures with a wearable biopotential technology (Sensor Dot)
IRAS ID
280186
Contact name
Arjune Sen
Contact email
Sponsor organisation
University Hospital Leuven (UZ Leuven)
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Epilepsy is a serious and common neurological disorder marked by recurrent epileptic seizures (1). Epilepsy has a prevalence of around 0.5% and affects around 50 million people worldwide (2). Video-Electroencephalography (video-EEG) is the clinical standard for diagnosing and managing people with epilepsy. Video-EEG can generate accurate results, but the equipment is bulky and requires a hospital admission in most cases. Preliminary evidence indicates that more user-friendly and discreet wearable devices could become a powerful tool to manage the care of people with epilepsy. Their small size and simple operation make them ideally suited for ultra-long-term use at home, but also restrict the number of EEG channels that can be captured and do not have video recording capabilities.
The multicenter, observational SeizeIT2 study aims to collect scientific evidence on whether the Byteflies Sensor Dot (a 2-channel biopotential (ExG) and motion recording wearable) generates data that is of sufficient quality to objectively annotate epileptic seizures in the hospital and home environment for people with focal impaired awareness, absences, and/or tonic-clonic seizures. We will examine the accuracy of seizure annotations made on data derived from the wearable SensorDot, against those derived from the clinical standard (video-EEG) or patient-reported seizure diaries. Additionally, the resulting database of seizure annotations will be a valuable resource for continued research on epilepsy and the development of seizure detection algorithms that can improve the standard of care for people with epilepsy.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0009
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion