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.
ID
Bron
Verkorte titel
Aandoening
epilepsy
epilepsie
seizure detection
aanvalsdetectie
heart rate
hartfrequentie
accelerometry
accelerometrie
video analysis
video analyse
audio analysis
audio analyse
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
the detection rate of the combination of heart rate and accelerometry analysis and the added value of video and audio detection.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Each patients will be oberved for 3 months.
Onderzoeksproduct en/of interventie
No intervention. Assessment of a diagnostic sensor system (armband, videocamera).
Publiek
P.O. Box 30.007
J. Arends
Assen 9400 RA
The Netherlands
+31 (0)592 334883
Johan.Arends@GGZDrenthe.nl
Wetenschappelijk
P.O. Box 30.007
J. Arends
Assen 9400 RA
The Netherlands
+31 (0)592 334883
Johan.Arends@GGZDrenthe.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3950 |
| NTR-old | NTR4115 |
| Ander register | : SD1 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |