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The ‘Livassured’ Combined sensor system to detect Epileptic Nocturnal SEizures

The performance of the ‘Livassured’ Combined sensor system in the detection of Epileptic Nocturnal SEizures (LICSENSE).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20529
Enrollment
60
Registered
2013-08-13
Start date
2014-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy epilepsie seizure detection aanvalsdetectie heart rate hartfrequentie accelerometry accelerometrie video analysis video analyse audio analysis audio analyse

Interventions

No intervention. Assessment of a diagnostic sensor system (armband, videocamera).

Sponsors

Kempenhaeghe, SEIN, UMCU.
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the detection rate of the combination of heart rate and accelerometry analysis and the added value of video and audio detection.

Secondary

MeasureTime frame
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.

Contacts

Public ContactJ. Arends

GGZ Drenthe, Department of Psychotic Disorders, Mental Health Care Services Drenthe, P.O. Box 30.007

Johan.Arends@GGZDrenthe.nl+31 (0)592 334883

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)