Development of a multimodal seizure detection instrument to improve safety and disease management of epilepsy patients at home

Development of a multimodal seizure detection instrument to improve safety and disease management of epilepsy patients at home - Nocturnal Seizure Detector

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35980

Enrollment

100

Registered

2011-12-27

Start date

2012-02-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

epilepsy seizures

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with refractory epilepsy and nocturnal seizures who are referred for clinical video-EEG seizure recordings to the epilepsy monitoring unit of one of the participating centers.

Exclusion criteria

Exclusion criteria: Self-reported nocturnal seizure frequency must be at least 1 per week. The patient or parents/legal representatives must be capable of understanding Dutch and filling in questionnaires, and must be able to provide informed consent.

Design outcomes

Primary

Measure	Time frame
The outcome parameter is the performance (in terms of sensitivity and positive predictive value) of the MSDI against the gold standard of nocturnal video-EEG recording, so the association between seizures detected by the MSDI and seizures detected by video-EEG.	—

Secondary

Measure	Time frame
Secondary endpoints are: (1) User friendliness measured by questionnaires on the valued aspects of the system and on potential objections. (2) Inventory of the expectations of the performance of a seizure detection device from patients and caregivers and clinicians.	—

Countries

Netherlands

Outcome results