NCT03207685

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

Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Empatica, Inc. · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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). Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG. A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Additional Seizure Monitoring	Embrace could offer an additional layer of seizure monitoring

Timeline

• Start date: 2017-06-30
• Primary completion: 2019-01-15
• Completion: 2022-01-01
• First posted: 2017-07-05
• Last updated: 2021-02-02

Locations

2 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated device study