Quality of Life in Epilepsy Patients Wearing a Biosensor for Seizure Detection Through Electrodermal Activity and Accelerometry - a Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- The mean change from Baseline of the total score, of the french version of the Quality of life Epilepsy inventory-31
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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:(3 month)
- Total number of true and false positives seizure detection(3 month)
- The usability total score of Embrace and Mate apps(3 month)
- The utility total score of the system in general(3 month)
Investigators
Philippe Ryvlin
Head of Department of Clinical Neurosciences
Centre Hospitalier Universitaire Vaudois