NCT06180538

Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-12-22
• Last updated: 2023-12-22