NCT03206502

Embrace: Seizure Characterization

Characterizing Sleep, Stress, and Seizures in Daily Life: An Internet-based Study With the Empatica Embrace Watch and Smartphone-based Diary-alert System

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100,000 (estimated)
• Sponsor: Empatica, Inc. · Industry
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Accepted

Summary

The study is intended to characterize sleep, stress, and seizures in daily life with the Empatica Embrace watch and smartphone-based diary-alert system. The primary study objective is to collect and validate biometric signals from epilepsy patients using the Empatica Embrace watch and compare them to ictal events captured from human (patient and caregiver) reports.

Detailed description

Patients use the Embrace sensor with a smartphone app, "Alert". The sensor attempts to capture convulsive seizure events such as generalized tonic-clonic seizures (GTCS's), and to initiate an alert when such an event is captured. Patients can also enter seizures (captured or not, GTCS or not) into the "Mate" diary, and they can cancel or mark false alarms if Embrace triggered a false alarm.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Embrace + Alert App	Participants will wear an Embrace smartwatch to collect data, and will provide survey/diary information on the occurrence of seizures. The device sends data to the Alert app, which issues either true detections or false alarms when it detects a possible convulsive seizure. Participants are asked to either cancel (in real time) or mark (at a later time) all false alarms using the Alert app.

Timeline

• Start date: 2016-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2017-07-02
• Last updated: 2020-08-24

Regulatory

• FDA-regulated device study