Seizure alarm with wearable electrocardiogram device for people with epilepsy
| ISRCTN | ISRCTN85640482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85640482 |
| Secondary identifying numbers | DFF Sagsnummer: 0134-00400B |
- Submission date
- 14/08/2024
- Registration date
- 21/08/2024
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
The main aim of this study is to create a wearable seizure alarm which can detect epileptic seizures. Recent studies have shown that heart rate variability analysis measured with an electrocardiogram (ECG) can detect seizures in patients with epilepsy. Therefore, this study will develop an online detection of epileptic seizures using small, wearable and wireless ECG devices. The study will assess the detection of seizures using a wearable ECG patch, which sends ECG data to a smartphone with implemented real-time seizure detection algorithms, during long-term video-EEG monitoring.
Who can participate?
Patients above the age of 3 years and with a diagnosis of probable focal or generalized epilepsy, enrolled for long-term video/EEG monitoring at Aarhus University Hospital or the Danish Epilepsy Center
What does the study involve?
The participants will wear the ECG device during their 1-5 days of term video/EEG monitoring and will respond to the seizure detection app on a smartphone.
What are the possible benefits and risks of participating?
If and when commercialized the wearable seizure alarm will be a vital asset for patients enabling caregivers and families to take necessary precautions during seizures and obtain an objective seizure count to optimize treatment. Side effects of temporary skin irritation may occur at the location of the ECG electrodes.
Where is the study run from?
Aarhus University Hospital (Denmark)
When is the study starting and how long is it expected to run for?
August 2021 to December 2024
Who is funding the study?
Danish Council for Independent Research (Denmark)
Who is the main contact?
1. Assistant Professor Jesper Jeppesen, jespjepp@rm.dk
2. Professor Sándor Beniczky, sandor.beniczky@clin.au.dk
Contact information
Principal Investigator
Palle Juul-Jensens Boulevard 165, plan 2, krydspunkt J209
Århus N
8200
Denmark
 ORCID ID |
0000-0002-6035-6581 |
|---|---|
| Phone | +45 (0)22888925 |
| sandor.beniczky@clin.au.dk |
Public, Scientific
Palle Juul-Jensens Boulevard 165, plan 2, krydspunkt J209
Århus N
8200
Denmark
| ORCID ID |
0000-0002-3095-2040 |
|---|---|
| Phone | +45 (0)22888925 |
| jespjepp@rm.dk |
Study information
| Study design | Multicenter Phase III clinical trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Seizure alarm with wearable electrocardiogram device for people with epilepsy: a Phase III study |
| Study objectives | The overall aim of this study is to investigate if an implementation of a heart rate variability (HRV)-based seizure detection algorithm into small, wearable ECG devices, is reliable as a seizure alarm system. The hypotheses are: Heart rate variability algorithms implemented into a small, non-invasive, wearable and wireless ECG device can reliably detect seizures in real-time, and send seizure alarms. |
| Ethics approval(s) |
Approved 13/01/2022, Medical Research Ethics Committees (Ørestads Boulevard 5, København S, 2300, Denmark; +45 (0)72 21 66 77; dketik@dketik.dk), ref: Sagsnr: 2119788 |
| Health condition(s) or problem(s) studied | Epilepsy |
| Intervention | The recording and data collection will be done using the portable ECG device, C3 Holter Monitor patch. The patients will be recorded during the whole 1-5 day period they are enrolled for video-EEG long-term monitoring (LTM). During the enrolment period, patients will complete a standardized training session (exercise bike) to obtain a control period, as HRV has been proven to change with physical exercise. Furthermore, the patients will be asked to perform an algorithmic stress test, as cognitive stress is known to influence sudden changes in the HRV parameters. Statistical analysis of the sensitivity and specificity (false positive alarms) of seizure detection by means of the HRV algorithm developed in a previous study (Jeppesen et al., Epilepsia 2019) will be conducted for the whole enrollment period of 1-5 days (inclusive the exercise and stress test). This will be done both individually and group-specifically (epilepsy form and type). The applicability and usability of the mobile seizure detection application and device will be evaluated. Significant HRV differences between frontal lobe and temporal lobe epilepsy will be identified. The seizure detection app will log all seizure alarms and register patient responses to the alarms. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | C3 Holter Monitor patch |
| Primary outcome measure | Seizure detection sensitivity and false alarm rate using the wearable ECG device in connection with the seizure detection app for patients with marked autonomic changes during seizures who are enrolled in a 1-5 days long-term video-EEG monitoring |
| Secondary outcome measures | 1. Seizure detection sensitivity and false alarm rate using the wearable ECG device in connection with the seizure detection app for patients without marked autonomic changes during seizures who are enrolled in a 1-5 days long-term video-EEG monitoring 2. Sensitivity of specific seizure types (focal and generalized seizures) of the wearable ECG device in connection with the seizure detection app for the enrolled patients in the 1-5 days long-term video-EEG monitoring study 3. Applicability and usability of the mobile seizure detection application and device of the enrolled patients in the 1-5 days long-term video-EEG monitoring study, assessed using side effects (e.g. skin irritation), dropout rates and reasons for dropouts |
| Overall study start date | 01/08/2021 |
| Completion date | 01/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 4 Years |
| Sex | Both |
| Target number of participants | 100-120 |
| Key inclusion criteria | 1. Patients enrolled for long-term video/EEG monitoring at Aarhus University Hospital or Danish Epilepsy Center 2. Above the age of 3 years 4. Diagnosis of probable focal or generalized epilepsy |
| Key exclusion criteria | 1. Pregnant women will be excluded from the study due to foreseeable noise on the ECG recording 2. Incompetent adults |
| Date of first enrolment | 07/02/2022 |
| Date of final enrolment | 01/11/2024 |
Locations
Countries of recruitment
- Denmark
Study participating centres
Palle Juul-Jensens Boulevard 165, plan 2, krydspunkt J209
Århus N
8200
Denmark
Dianalund
4293
Denmark
Sponsor information
University/education
Department of Clinical Medicine
Palle Juul-Jensens Boulevard 11
Århus N
8200
Denmark
| Phone | +45 (0)20234527 |
|---|---|
| clin@au.dk | |
| Website | https://clin.au.dk/ |
"ROR" |
https://ror.org/01aj84f44 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Danish Council for Independent Research, Det Frie Forskningsrad, Independent Research Fund Denmark, DFF
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated during and/or analysed during the current study are not expected to be made available due to the approval limitations by the ethical committee |
Editorial Notes
17/01/2025: The intention to publish date was changed from 01/12/2024 to 01/03/2025.
14/08/2024: Study's existence confirmed by the Medical Research Ethics Committees.
