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Seizure alarm with wearable electrocardiogram device for people with epilepsy

Seizure alarm with wearable electrocardiogram device for people with epilepsy: a Phase III study

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN85640482
Enrollment
100
Registered
2024-08-21
Start date
2022-02-07
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy Nervous System Diseases

Interventions

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 lon

Sponsors

Aarhus University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Pregnant women will be excluded from the study due to foreseeable noise on the ECG recording 2. Incompetent adults

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Denmark

Contacts

Public ContactJesper Jeppesen
jespjepp@rm.dk+45 (0)22888925

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026