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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-10-31

Brief Summary

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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).

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Detailed Description

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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

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Epilepsy, Tonic-Clonic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Monitored Subjects

Single arm study of subjects that have been issued an EpIWatch

Group Type OTHER

Physiological signal monitoring and seizure detection

Intervention Type DEVICE

Data collection and as an adjunct to other methods of seizure monitoring

Interventions

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Physiological signal monitoring and seizure detection

Data collection and as an adjunct to other methods of seizure monitoring

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No