EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
Completed · Not applicable
Conditions studied: Epilepsy, Tonic-Clonic
In brief
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).
Key facts
- Study ID
- NCT05059002
- Run by
- EpiWatch, Inc.
- People needed
- 242
- Starts
- 2021-09-20
- Expected to finish
- 2023-10-31
- Last updated by the study team
- 2025-02-04
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Medicine — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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