Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
26 participants
INTERVENTIONAL
2018-10-10
2021-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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experimental group
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
Embrace with Alert and Mate apps
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.
Control group
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
Embrace with Mate app only
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.
Interventions
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Embrace with Alert and Mate apps
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.
Embrace with Mate app only
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure
* primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion
* seizure frequency \> 1 seizure/month during the last three months
* signed the informed consent form
* own a mobile phone device compatible with the embrace apps
* able to use the device without help from caregivers
Exclusion Criteria
* epilepsy diagnosis remains uncertain
* evidence of psychogenic non epileptic seizures
* seizure frequency below 1/month during any of the three previous months
* past-history of nickel allergy and contact dermatitis
* did not sign the informed consent form
* does not own mobile phone device compatible with the embrace apps
* cognitive or behavioral impairment preventing compliance or correct use of the device and app.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Philippe Ryvlin
Head of Department of Clinical Neurosciences
Locations
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Neurotech
Lausanne, , Switzerland
Countries
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Other Identifiers
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EMBQL
Identifier Type: -
Identifier Source: org_study_id
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