Seizure alarm with wearable electrocardiogram device for people with epilepsy
Phase 3
- Conditions
- EpilepsyNervous System Diseases
- Registration Number
- ISRCTN85640482
- Lead Sponsor
- Aarhus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
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
1. Pregnant women will be excluded from the study due to foreseeable noise on the ECG recording
2. Incompetent adults
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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<br>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<br>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