CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 496 enrolled
Drug / intervention
Sensor Dotdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04284072
NCT04284072N/ACompleted
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A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Feb 25, 2020·Updated Nov 8, 2022

In Brief

A clinical study evaluating Sensor Dot for Epilepsy. Completed, enrolled 496 participants across 7 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Germany, Portugal, Sweden, United Kingdom
CollaboratorsFreiburg University, King's College London, Oxford University Hospitals NHS Trust, University of Coimbra, Karolinska Institutet, RWTH Aachen University, UCB Pharma, Byteflies, Helpilepsy

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 25, 2020
Enrollment StartJun 22, 2020
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago

Interventions

Sensor Dotdevice

Multimodal (EEG, ECG, EMG and motion) seizure monitoring with Sensor Dot to complement EMU-based video-EEG monitoring (EMU Phase), and optional home-based seizure diary logging (Home Phase).