Embrace and Quality of Life

Not Applicable

Terminated

• Conditions: Epilepsy, Tonic-Clonic

• Registration Number: NCT03831802
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-21
• Study Start: 2018-10-10
• Primary Completion: 2018-10-10
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Study Completion: 2021-08-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31	3 month	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.

Secondary Outcome Measures

Name	Time	Method
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:	3 month	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.
Total number of true and false positives seizure detection	3 month	Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
The usability total score of Embrace and Mate apps	3 month	Will be assessed with the System usability scale (SUS). The score are to 0 from 100.
The utility total score of the system in general	3 month	will be assessed via a structured questionnaire-based interview that was Tailored for this study

Trial Locations

Locations (1)

Neurotech; 🇨🇭 Lausanne, Switzerland