NCT05059002

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: EpiWatch, Inc. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Epilepsy, Tonic-Clonic

Interventions

Type	Name	Description
DEVICE	Physiological signal monitoring and seizure detection	Data collection and as an adjunct to other methods of seizure monitoring

Timeline

• Start date: 2021-09-20
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2021-09-28
• Last updated: 2025-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study