Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Epilepsy Clinical Trial

— EPIVIEWS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180538
• Other study ID #: EPIVIEWS
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Royal College of Surgeons, Ireland
• Contact: John David Damalerio
• Phone: +353 83 017 0056
• Email: johndaviddamale22[@]rcsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Beaumont Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life in Epilepsy Inventory (QOLIE-31)		Prior to admission