US Clinical Trial

Joining the Embrace clinical trial

The clinical trial is only for US customers using the Embrace 1. If you reside outside of the US, you can still use the Embrace and the Alert system without participating in a trial. Eligibility Criteria You have an Embrace. You can read and und...

Purpose of the clinical trial

We aim to demonstrate how effective Embrace and the Alert App are in detecting movement and EDA patterns that might be related with tonic-clonic seizures and alerting caregivers in real-world conditions.   It’s necessary to test on a large number ...

Participating without an Embrace

It’s not possible to participate in the clinical trial without an Embrace. The opportunity to participate is only open only to those that have purchased an Embrace 1 or have received a donated watch in the US, and meet eligibility requirements. If...

What is required to report as a participant

As a participant or parent of a participant we’ll ask that you report: True Detection: Confirm if you have a Generalized Tonic Clonic seizure (aka “Grand Mal” or “shaking seizure”) and the system reports it correctly. False Alarm: Tell us if the ...

Withdraw participation

You can withdraw at any time and discontinue use of the Alert App. To withdraw from the study, the best thing to do would be to email epilepsy-research@empatica.com. 

Benefits of the clinical trial

By participating in the clinical trial you are helping advance scientific progress in the Epilepsy research space. You are also contributing to an improved user experience with the Embrace (such as reduced false alarm rate and better activity esti...

Risks of participating

Using the Embrace watch and Alert app should not pose a significant risk to your health and wellbeing. However, there are still some things to consider. If the Embrace gets dirty, an allergen can build up and lead to a skin irritation - to reduce ...

Choosing not to participate

Participation in the clinical trial is entirely voluntary. If you choose not to participate you can still use the Embrace to track your sleep, rest and activity with the Mate app. Please note, however, that seizure detection and alerting capabilit...

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