Embrace: Seizure Characterization

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03206502
• Other study ID #: 2016-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2026

Study information

• Verified date: August 2020
• Source: Empatica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Empatica, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	System Usability	The System Usability Scale will be given to assess system usability	After one month of use.
Primary	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	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)