Embrace and Quality of Life (EMBQL)

V

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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