Back to results

Embrace: Seizure Characterization

Primary Purpose

Epilepsy

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Embrace + Alert App

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

1 Year - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embrace+Alert App

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03206502

First Posted

November 21, 2016

Last Updated

August 20, 2020

Sponsor

Empatica, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03206502

Brief Title

Embrace: Seizure Characterization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2026 (Anticipated)

Study Completion Date

May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Empatica, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Embrace+Alert App

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Embrace + Alert App

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity of the GTCS detection of the Embrace + Alert app

Description

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.

Time Frame

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 Measure Information:

Title

False alarm rate of the GTCS detection of the Embrace + Alert app

Description

Time Frame

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 Pre-specified Outcome Measures:

Title

System Usability

Description

The System Usability Scale will be given to assess system usability

Time Frame

After one month of use.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Embrace: Seizure Characterization

We'll reach out to this number within 24 hrs