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

NCT03207685 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-02

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Additional Seizure Monitoring

Embrace could offer an additional layer of seizure monitoring

Sponsors & Collaborators

  • Empatica, Inc.

    lead INDUSTRY

Principal Investigators

  • Rosalind W Picard, Sc.D. · Empatica, Inc.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-01-15
Completion
2022-01-31
FDA Device
Yes

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207685 on ClinicalTrials.gov