Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

Not yet recruiting

• Conditions: Epilepsy

• Registration Number: NCT06180538
• Lead Sponsor: Royal College of Surgeons, Ireland

Brief 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.

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22
• Study Start: 2024-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life in Epilepsy Inventory (QOLIE-31)	Prior to admission