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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embrace+Alert App | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embrace + Alert App | Device | 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability | The System Usability Scale will be given to assess system usability | After one month of use. |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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