An interventional study of Physiological signal monitoring and seizure detection in Epilepsy, Tonic-Clonic, sponsored by EpiWatch, Inc.. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by EpiWatch, Inc. · Not applicable, Interventional, and Supportive care
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).
Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.
This study's enrollment of 242 is above the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.
Browse Epilepsy, Tonic-Clonic studies →This is the only study on the registry with EpiWatch, Inc. as lead sponsor.
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Exclusion Criteria:
Single arm study of subjects that have been issued an EpIWatch
Device: Physiological signal monitoring and seizure detection
Data collection and as an adjunct to other methods of seizure monitoring
Comparison of video-EEG to EpiWatch Results for PPA
Lower bound of 95% confidence interval of the positive percent agreement (PPA) \> 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Time frame: 6 months
Comparison of video-EEG to EpiWatch results for FAR
Upper bound of 95% confidence interval of the false alarm rate (FAR) \<.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Time frame: 6 months
Pediatric Ambulation Positive Percent Agreement
Estimate the PPA in pediatric participants in ambulation in addition to at rest
Time frame: 6 months
Pediatric Ambulation False Alarm Rate
Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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