US Clinical Trial

Joining the Embrace clinical trial

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

Purpose of the clinical trial

The purpose of the clinical trial is to demonstrate how effective Embrace and Alert App are in detecting for possible convulsive seizures and alerting caregivers.    It’s necessary to test on a large number of people to ensure that any benefit der...

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 owners of the original Embrace in the United States that meet the eligibility requirements. If you reside outside of the...

What is required to report as a participant

As a participant, or parent of a participant, we’ll ask that you report: True Detection: When Embrace correctly detects a tonic-clonic seizure. False Alarm: When Embrace alerts for an activity that is not a tonic-clonic seizure. Missed Detection...

Withdrawing participation

You can withdraw at any time and discontinue use of the Alert App. To withdraw from the study, please email us at epilepsy-research@empatica.com stating your intention to withdraw.   Withdrawing your participation from the clinical trial will disa...

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 Embrace and the Alert App do not pose a significant risk to your health and well-being. However, there are still some things to consider. If the Embrace gets dirty, an allergen could build up and lead to a skin irritation. To reduce your ris...

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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