Embrace and Quality of Life (EMBQL)

Vaud University Hospital Center

Status: Terminated

Conditions: Epilepsy, Tonic-Clonic

Treatments: Device: Embrace with Alert and Mate apps; Device: Embrace with Mate app only

Study type: Interventional

Funder types: Other

Identifiers

NCT03831802

EMBQL

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female aged >18 years old
• 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

• patients aged less than 18 years old
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

experimental group

Experimental group

Description:

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

Treatment:

Device: Embrace with Alert and Mate apps

Control group

Active Comparator group

Description:

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

Treatment:

Device: Embrace with Mate app only