Clinical trial NCT03206502: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Lead sponsor: Empatica, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 100000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity of the GTCS detection of the Embrace + Alert app
timeFrame: 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 outcomes:
measure: False alarm rate of the GTCS detection of the Embrace + Alert app
timeFrame: 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 outcomes:
measure: System Usability
timeFrame: After one month of use.
Locations:
Study officials:
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