|- candidate number||15270|
|- NTR Number||NTR4115|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-aug-2013|
|- Secondary IDs||SD1 |
|- Public Title||The ‘Livassured’ Combined sensor system to detect Epileptic Nocturnal SEizures |
|- Scientific Title||The performance of the ‘Livassured’ Combined sensor system in the detection of Epileptic Nocturnal SEizures (LICSENSE).|
|- hypothesis||This is a clinical trial in the home environment of 60 epilepsy patients to investigate the sensitivity and positive predictive value of a multimodal sensor system (‘LivAssured’) for the detection of nocturnal motor seizures. |
|- Healt Condition(s) or Problem(s) studied||Epilepsy, Seizure detection, Heart rate, Video Analysis, Audio Analysis, Accelerometry|
|- Inclusion criteria||1. Between 2 and 18 years of age, 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 motor seizure frequency: 1/week.
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.
|- Exclusion criteria||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 tonic seizures (often short lasting) or isolated myoclonias.
3. Inability to comply to the trial procedure.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-apr-2015|
|- Target number of participants||60|
|- Interventions||No intervention. Assessment of a diagnostic sensor system (armband, videocamera).|
|- Primary outcome||the detection rate of the combination of heart rate and accelerometry analysis and the added value of video and audio detection.|
|- Secondary outcome||the performances of heart rate, accelerometry, video and audio alone, the technical performance of the sensor system and quality of life and ‘trust’ of the patient and caregivers. |
|- Timepoints||Each patients will be oberved for 3 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Arends|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J. Arends|
|- Sponsor/Initiator ||SEIN, University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Nuts/Ohra, ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||This is a clinical trial in the home environment of 60 epilepsy patients to investigate the sensitivity and positive predictive value of a multimodal sensor system (‘LivAssured’) for the detection of nocturnal motor seizures. Results for combined analysis of heart rate and accelerometry and the added value of video/audio analysis will be the primary endpoints.
Secondary end points are the performances of heart rate, accelerometry, video and audio alone, the technical performance of the sensor system and quality of life and ‘trust’ of the patient and caregivers.
|- Main changes (audit trail)|
|- RECORD||13-aug-2013 - 27-aug-2017|