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 range

5 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

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