An interventional study of Sensor Dot in Epilepsy, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 7 sites in 5 countries. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic
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.
Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.
A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.
The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 496 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study with a device intervention for epileptic seizure monitoring in subjects with refractory focal impaired awareness, tonic-clonic, and/or typical absence seizures.
Device: Sensor Dot
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).
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Time frame: up to two weeks
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Time frame: up to two weeks
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Time frame: up to two weeks
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Time frame: up to two weeks
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Time frame: up to two weeks
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Time frame: up to two weeks
Sensor Dot usability
We will assess the usability of the device as perceived by users (patients and healthcare personnel) via surveys
Time frame: up to two weeks
To assess seizure duration
From the Sensor Dot data, we will be able to assess seizure duration
Time frame: up to two weeks
To assess the usability of the seizure e-diary
We will asses usability of the electronic seizure diary
Time frame: up to two weeks
To evaluate the accuracy of automated seizure detection algorithms
We will use the collected data and seizure annotations to develop algorithms to automatically detect epileptic seizures. We plan to evaluate how accurate these new automated seizure detection algorithms are.
Time frame: 2 years
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Accuracy as determined by expert reviewers
Time frame: up to 2 weeks
Sensor Dot Performance
We will assess the technical performance of the device by comparing the actual length of recorded data against the expected recording length, and what percentage of the data is high quality enough to make seizure annotations.
Time frame: up to 2 weeks
Plan to share: Yes — We plan to share the individual biosignals (EEG, EMG, ECG and movement) and 24-channel seizure-annotated EEG data, de-identified demographic and epilepsy-related data two years after the finish of the study (1-1-2024) upon request to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitaire Ziekenhuizen KU Leuven