An interventional study of Embrace + Alert App in Epilepsy, sponsored by Empatica, Inc.. Enrolling by invitation. Open to participants aged 1 Year to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Empatica, Inc. · Not applicable, Interventional, and Diagnostic
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.
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Empatica, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
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.
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)
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.
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)
System Usability
The System Usability Scale will be given to assess system usability
Time frame: After one month of use.
No study locations are listed for this record.
Plan to share: No
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Empatica, Inc.