Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring (EPIVIEWS)

EPIVIEWS: Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy

Detailed Description

Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life.

New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers.

Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: John David Damalerio; Phone Number: +353 83 017 0056; Email: johndaviddamale22@rcsi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Epilepsy Monitoring Unit in Beaumont Hospital who have a history of tonic-clonic seizures

Description

Inclusion Criteria:

1. The participant is over the age of 18
2. The participant has access to a smartphone
3. The participant has a history of generalised tonic-clonic seizures in the past year

Exclusion Criteria:

1. The participant lacks capacity to give informed consent (e.g. has intellectual disability)
2. The participant is a paediatric patient (aged below 18)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of Life in Epilepsy Inventory (QOLIE-31)	Prior to admission

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: wearable device
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: EPIVIEWS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No