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A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and accelerometry. These measures are used to automatically detect epileptic seizures that are transmitted to a mobile phone-based system for alerts and recording.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The experimental group will make use of the Alert app that sends alarms to patients mobile devices, and if desired to the mobile devices of their caregivers. This group will also use the Mate app which is used as a seizure diary |
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| Control group | Active Comparator | The control group will only use the Mate app and not the Alert app. This group will thus not receive any notification, from the device, and will be unaware, of the devices performance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embrace with Alert and Mate apps | Device | Patients will wear the device on their wrist as often as possible during the day and night. The Embrace Watch contains sensors and memory recordings of electrodermal activity, temperature and physical activity from the wearer. This group will receive notifications on the mobile phone when seizure takes place. Quality of life questionnaires will be filled by the patients at the first follow-up and final assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31 | The change between the QOLIE-31 questionnaire total score measured at the first and the final visit will serve as primary endpoint. The possible range of each scale's final score is from 0 to 100. higher scores reflect better quality of life. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from Baseline of the total scores of seven Quality of Life in Epilepsy Inventory-31 subscales covering the following epilepsy-specific domains: | Epilepsy-specific domains are: seizure worry, overall QOL, emotional well being, energy/fatigue subscales, medication effects, work-driving-social limits, cognitive function subscales. The possible range of each scale's final score is from 0 to 100. Higher scores reflect better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurotech | Lausanne | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D004830 | Epilepsy, Tonic-Clonic |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Embrace with Mate app only | Device | Patients will wear the device on their wrist as often as possible during the day and night. This group will just use the Mate app that summarizes Embrace Watch data for the owner and captures contextual information around events.This group will not receive any alert notification on the mobile phone when a seizure takes place. |
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| 3 month |
| Total number of true and false positives seizure detection | Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app | 3 month |
| The usability total score of Embrace and Mate apps | Will be assessed with the System usability scale (SUS). The score are to 0 from 100. | 3 month |
| The utility total score of the system in general | will be assessed via a structured questionnaire-based interview that was Tailored for this study | 3 month |