Embrace and Quality of Life

Epilepsy, Tonic-Clonic Clinical Trial

— EMBQL  

Official title:

Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03831802
• Other study ID #: EMBQL
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: August 20, 2021

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: August 20, 2021
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Epilepsy, Tonic-Clonic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Neurotech	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	3 month
Secondary	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
Secondary	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
Secondary	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