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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy
• Intervention / Treatment: Device: Embrace + Alert App

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 97 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be between the ages of 1-99
• Anyone (healthy or not) can participate
• Adult participant must either be able to give consent or must have an acceptable surrogate capable of giving consent on their behalf.
• Participants under age 18 must have an adult guardian give informed consent, and if capable, the patient must give informed assent.
• Participants with GTCS must have a functioning smartphone (iOS or Android) that can be paired with the Embrace over a Bluetooth Low Energy connection and agree that it can be kept on or near their person.
• Participants with GTCS (or their surrogate) must be able to identify one or more "designated frequent caregivers," who has a functioning phone, agrees to keep it regularly charged, agrees to receive alerts, and agrees to respond to alerts promptly to the best of their ability.
• Participants must be fluent in the language of the consent forms (Currently limited to English but Spanish and other languages are planned).
• Participants must reside in the United States.

Exclusion Criteria:

• Participants must not have broken or injured skin at the wrist or leg location where Embrace is worn, and they must be able to tolerate wearing Embrace snugly for long periods of time. Thus, they should not have allergies to the material composition of the Embrace watch, or discomfort wearing a wristwatch or leg-band device.
• Participants should not be homeless.
• Participants should not have active dependence on substances that are not currently prescribed by their doctor (e.g. alcohol, pain medications, illegal drugs) or be taking substances that they are not willing to disclose as a study participant.
• Participants must not be pregnant or planning to become pregnant within six months at the time of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Embrace+Alert App; Participants are allowed to enter the trial (to use Embrace+Alert app) whether or not they have epilepsy. People without epilepsy may use Alert in this trial even though they are not expected to have seizures, as long as they are willing to mark false positives. Since many people with epilepsy live active lives and appear perfectly healthy outwardly, it is important that their active lifestyle data not trigger false alarms. Allowing healthy participants without epilepsy to contribute active lifestyle data helps us make the detection algorithm even stronger and better.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the GTCS detection of the Embrace + Alert app	The number of GTCS automatically detected by Embrace will be compared to the total recorded by the wearer+caregiver in a seizure diary. This fraction is the sensitivity.	The primary outcome is assessed continuously over the trial period (each new seizure is counted and summed for each person; the average time period is 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False alarm rate of the GTCS detection of the Embrace + Alert app	The number of alerts elicited by Embrace+Alert app that do NOT correspond to convulsive seizures marked in the seizure diary are "false alarms". False alarms can also be explicitly marked by patients.	The secondary outcome is assessed continuously over the trial period (each false alarm is counted and summed for a running total within each person; the average time period is 6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability	The System Usability Scale will be given to assess system usability	After one month of use.

Collaborators and Investigators

• Sponsor: Empatica, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: 2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No