The 'Livassured' Combined Sensor system to detect Epileptic Noctural SEizures (LICSENSE)
- Conditions
- Epilepsy10039911
- Registration Number
- NL-OMON44973
- Lead Sponsor
- Epilepsiecentrum Kempenhaeghe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
Subjects who meet all of the following criteria are eligible for this trial:
1. Between 2 and 18 years of age with or without mental impairment, or between 18 - 65 years with a mental impairment.
2. Major motor seizures defined as tonic-clonic, generalized tonic, hypermotor or series of myoclonic seizures.
3. Minimal nocturnal seizure frequency: 1/month.
4. The mentally impaired patients all live in the long-term facilities at Kempenhaeghe or SEIN. Children may live in their family home.
5. Informed consent form signed by legal representatives.
Subjects meeting one or more of the following criteria cannot be selected:
1. Intensive non-epileptic movement patterns such as severe choreatiform movements due to birth defects, intensive sleep walking, frequent night terrors (> 1/night)
2. Only minor motor seizures: non-generalised or short (< 10 sec.) tonic seizures or isolated myoclonias.
3. Pacemaker
4. Inability to comply to the trial procedure
5 Dark colored skin.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The combined analysis of heart rate and accelerometry, the added value of<br /><br>video/audio analysis and the technical performance are primary endpoints.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary end points are the performances of heart rate, accelerometry, video<br /><br>and audio alone, comparison with the Emfit bed sensor, quality of life,<br /><br>optimalisation of care and levels of trust of caregivers in system performance.</p><br>