Epilepsy, Tonic-ClonicEMBQLNCT03831802
Embrace and Quality of Life
A study testing Embrace with Alert and Mate apps and Embrace with Mate app only in people with Epilepsy, Tonic-Clonic, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Tonic-Clonic
- What is being tested?
- Embrace with Alert and Mate apps and Embrace with Mate app only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2018to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Epilepsy, Tonic-Clonic
- Being tested
- Embrace with Alert and Mate apps, Embrace with Mate app only
- Keywords
- epilepsy, mhealth, quality of life
- Medical subject headings
- Epilepsy, Tonic-Clonic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace with Alert and Mate appsDevice
Also called experimental group's intervention
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 onlyDevice
Also called Control group's intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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 Receives: Device: Embrace with Alert and Mate apps |
| Control group | Active comparator | 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 Receives: Device: Embrace with Mate app only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (4)
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.
Measured: 3 month
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
Measured: 3 month
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.
Measured: 3 month
The utility total score of the system in general
will be assessed via a structured questionnaire-based interview that was Tailored for this study
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start10 Oct 2018
- Primary completion10 Oct 2018
- Study completion20 Aug 2021
Why it stopped: because of technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Tonic-ClonicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Ryvlin, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831802
- Sponsor's protocol ID
- EMBQL
- Acronym
- EMBQL
- Status last verified
- Jul 2022
- First submitted
- 21 Aug 2018
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
- ClinicalTrials.gov ID
- NCT03831802
- Acronym / sponsor ID
- EMBQL / EMBQL
- Conditions
- Epilepsy, Tonic-Clonic
- Keywords
- epilepsy, mhealth, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of technical issues
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Embrace with Alert and Mate appsThe 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 |
| Control group | Active comparator | Device: Embrace with Mate app onlyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embrace with Alert and Mate appsAlso: experimental group's interventionPatients 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. | Device | experimental group |
| Embrace with Mate app onlyAlso: Control group's interventionPatients 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. | Device | Control group |
Primary outcome
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
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.
4 secondary outcomes
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
Total number of true and false positives seizure detection
Time frame: 3 month
The usability total score of Embrace and Mate apps
Time frame: 3 month
The utility total score of the system in general
Time frame: 3 month
Results and safety
The study was stopped early (reason given: because of technical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embrace with Alert and Mate apps and Embrace with Mate app only in people with Epilepsy, Tonic-Clonic, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: because of technical issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.