CompletedNot Applicable

EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System

United States242 participantsStarted 2021-09-20

Plain-language summary

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).

Who can participate

Age range5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to a site EMU for video-EEG monitoring * Age five and older at the time of enrollment * Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures * Willing and able to comply with study procedures Exclusion Criteria: * Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors * Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch * Inability or unwillingness to comply with study procedures

What they're measuring

Comparison of video-EEG to EpiWatch Results for PPA

Timeframe: 6 months

Comparison of video-EEG to EpiWatch results for FAR

Timeframe: 6 months

Trial details

NCT IDNCT05059002

SponsorEpiWatch, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Epilepsy, Tonic-Clonic trials