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

NCT05059002 | Completed DMC FDA Device

• 1 other identifier: EPW001
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Epilepsy, Tonic-Clonic

Keywords

Seizure Detection; Seizure; Digital Health

Outcome Measures

Primary Outcomes (2)

• Comparison of video-EEG to EpiWatch Results for PPA

  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

  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 Outcomes (2)

• Pediatric Ambulation Positive Percent Agreement

  6 months

• Pediatric Ambulation False Alarm Rate

  6 months

Study Arms (1)

Monitored Subjects

OTHER

Single arm study of subjects that have been issued an EpIWatch

Device: Physiological signal monitoring and seizure detection

Interventions

Physiological signal monitoring and seizure detection DEVICE

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

Monitored Subjects

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• EpiWatch, Inc.: lead

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Epilepsy, Tonic-Clonic; Seizures

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory L Krauss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: September 20, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 4, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)