Development and validation of an algorithm for an ultra low-power miniaturized device with accelerometry, electrocardiography and electromyography based tonic seizure detection.
Completed
- Conditions
- Epilepsy10039911
- Registration Number
- NL-OMON47184
- Lead Sponsor
- Epilepsiecentrum Kempenhaeghe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients who meet all of the following criteria are eligible for this study:
- Currently residing at Providentia (long stay facilities of Kempenhaeghe)
- Over 18 years of age
- Nightly tonic and/or tonic-clonic seizures
- Minimal seizure frequency: 1/week
- Informed consent form signed by legal representatives
Exclusion Criteria
Subjects meeting one or more of the following criteria cannot be selected:
- History of heart failure, significant heart disease or, obstructive sleep apnea
- Drugs or pacemakers that significantly influence heart rate (for example beta-blockers)
- Inability to comply with the test procedure
- Inability to tolerate the used electrodes
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the added value of electromyography analysis to<br /><br>the analysis of heartrate and accelerometry. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are analysis of heartrate and accelerometry,<br /><br>comparison to the Emfit bed sensor and quality of life. </p><br>