Seizure Forecasting Study

Empatica is conducting a first-of-its-kind Seizure Forecasting Study using real-world data collected by our EmbracePlus wearable.

The study aims to develop a seizure forecasting algorithm focused on providing a personalized risk prediction tool for people living with epilepsy.

Study Eligibility

• The study is open to US-based users of EpiMonitor, Empatica’s new FDA-cleared epilepsy monitoring system.
• Participants must be 6 years of age or older and have a diagnosis of or be at risk of epilepsy.
  • Subjects between the ages of 6 and 21 require the consent of their legal guardian to enroll in the study.

Participant Requirements for the Study

Participants will be required to:

• Wear EmbracePlus continuously and consistently, except during charging periods.
• Fill in surveys regarding medication intake, quality of life, seizure history, and experience using EpiMonitor.
  • The frequency of the survey requests may vary between 1 to 6 months.
• Maintain a seizure diary, correctly labeling seizures and false alerts using the EpiMonitor App.
• Participate in the study for 6-18 months.
• If you are not an independent user of EpiMonitor, your legal guardian must be able to complete the surveys and seizure labeling on your behalf.

Types of data collected

Empatica will collect data measured by the EmbracePlus smartwatch. This data includes seizure, sleep, and activity data, as well as additional information related to vital signs such as pulse rate and respiratory rate. Please note that pulse and respiratory rate data will not be available to users on the EpiMonitor app. Data is collected automatically and will be stored anonymously.

EpiMonitor Experience

All FDA-cleared EpiMonitor features will be available to study participants at all times. However, as the study aims to collect additional data from the EmbracePlus, the device’s PPG (Photoplethysmography) sensor will be intermittently activated.

You may notice a slight reduction in the battery life of the EmbracePlus when the green lights on the bottom are turned on. These lights indicate that the PPG sensor is active, computing additional data such as pulse rate and respiratory rate. As a result, the expected battery life is around 5 to 6 days.

Participating in the study will not impact the accuracy of the EpiMonitor seizure detection algorithm.

If you are withdrawn from the study or you choose to withdraw from the study for any reason, the experimental visualization and forecasting features will be removed from the EpiMonitor App, and the device battery life will return to up to 7 days. As long as you are subscribed to the EpiMonitor product, you will have all the EpiMonitor features available in your subscription tier.

Enrollment Process

Anyone can declare their interest in enrolling before purchasing EpiMonitor on our Online Store:

Choose the EmbracePlus box with ‘Join our Study’ and click on ‘Register to continue’

If you already have an account, log in with your credentials. If you don’t have an account, click on ‘Sign up’ to create one.

After logging in or completing the account registration, click on ‘Enrol now on our Seizure Forecasting Study’.

You will be asked to electronically sign the Study’s consent form.

Once the consent form is signed, you will be redirected to the purchase page with the $50 discount applied.

Enrollment Process if you have already purchased EpiMonitor

If you have already purchased and didn’t get the chance to join the study, you can go to your EpiMonitor account and follow these steps:

1. Click on the ‘Seizure Forecasting Study’ widget.
   

2. Click on ‘Enroll now’.
   

3. You will receive a consent form in your email. You just need to read and electronically sign it to complete the enrollment.

Withdrawing from the Study

You can withdraw at any time directly from your EpiMonitor Account or the EpiMonitor App by following these steps:

Withdrawal from the study is permanent and you will no longer be able to enroll again.

1. Log into your EpiMonitor account.

2. Click the ‘Seizure Forecasting’ widget.
   

3. Click ‘Withdraw from the Study’.
   

4. You’ll see a green banner on the top that confirms your withdrawal from the Study, and the Forecasting widget will disappear from the EpiMonitor Account.