- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03831802
Embrace and Quality of Life (EMBQL)
July 19, 2022 updated by: Philippe Ryvlin, Centre Hospitalier Universitaire Vaudois
Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lausanne, Switzerland, 1011
- Neurotech
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
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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.
Other Names:
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ACTIVE_COMPARATOR: 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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
Time Frame: 3 month
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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.
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3 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
Time Frame: 3 month
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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.
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3 month
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Total number of true and false positives seizure detection
Time Frame: 3 month
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Detected by the embrace device, saved via the alert app and controlled by the patient via the mate app
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3 month
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The usability total score of Embrace and Mate apps
Time Frame: 3 month
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Will be assessed with the System usability scale (SUS).
The score are to 0 from 100.
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3 month
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The utility total score of the system in general
Time Frame: 3 month
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will be assessed via a structured questionnaire-based interview that was Tailored for this study
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3 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 10, 2018
Primary Completion (ACTUAL)
October 10, 2018
Study Completion (ACTUAL)
August 20, 2021
Study Registration Dates
First Submitted
August 21, 2018
First Submitted That Met QC Criteria
February 4, 2019
First Posted (ACTUAL)
February 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMBQL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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