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

January 31, 2025 updated by: EpiWatch, Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Monitored Subjects
Single arm study of subjects that have been issued an EpIWatch
Device: Physiological signal monitoring and seizure detection
Data collection and as an adjunct to other methods of seizure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of video-EEG to EpiWatch Results for PPA
Time Frame: 6 months
Lower bound of 95% confidence interval of the positive percent agreement (PPA) > 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
6 months
Comparison of video-EEG to EpiWatch results for FAR
Time Frame: 6 months
Upper bound of 95% confidence interval of the false alarm rate (FAR) <.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Ambulation Positive Percent Agreement
Time Frame: 6 months
Estimate the PPA in pediatric participants in ambulation in addition to at rest
6 months
Pediatric Ambulation False Alarm Rate
Time Frame: 6 months
Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EpiWatch, Inc.

Investigators

  • Principal Investigator: Gregory L Krauss, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPW001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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