Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System

Status unconfirmed · Not applicable

Conditions studied: Epilepsy

In brief

To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).

Key facts

Study ID

NCT03207685

Run by

Empatica, Inc.

People needed

100

Starts

2017-06-30

Expected to finish

2022-01-01

Last updated by the study team

2021-02-02

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.

You may not qualify if…

• Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
• Women who are pregnant.
• Patients who are known or suspected to have a history of PNES only.
• Patients with known allergic reactions to nickel or stainless steel
• Infants who were born pre-term and may not have fully developed skin

Where it is running

• NYU Langone Medical Center — New York, New York, United States
• Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit — Roma, Italy

Full record on ClinicalTrials.gov

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