Promoting Implementation of Seizure Detection Devices in Epilepsy Care
Condition: Epilepsy in Children
MeSH terms: Epilepsy; Seizures
Study type: Interventional

Summary: 
      This is a multicenter home-based medical device intervention study, with prospective
      validation of the wearable seizure detection device (Nightwatch) and retrospective validation
      of remote sensors (video and audio detection) in children. The investigators will also
      perform a feasibility and utility analysis of Nightwatch.
    

Detailed description: 
      Various remote and wearable sensor devices have become available for the detection of
      potentially dangerous seizures, with limited impact on epilepsy care so far. Both the
      investigator's remote and wearable seizure detection devices (SDDs) have been extensively
      tested and proven highly sensitive. Yet the home performance in children, an important target
      population, had been insufficiently studied.

      Objective: 1. To test the performance of the wearable SDD (Nightwatch) prospectively and the
      remote SDD (automated video and audio analysis) retrospectively in children in a family home
      setting. 2. To assess the feasibility, cost-effectiveness and cost-utility of Nightwatch in
      children.

      Study design: A multicenter home-based medical device intervention study with prospective
      validation of our wearable SDD.

      Study population: 60 children (ages 4-16 years) with refractory epilepsy (≥1 major nocturnal
      seizure per week) recruited from the outpatient clinics of one of the participating epilepsy
      centers (Stichting Epilepsie instellingen Nederland (SEIN), Academic Centre of Epileptology
      Kempenhaeghe (Kempenhaeghe), University Medical Center Utrecht (UMCU)).

      Intervention: Phase I: Two months of baseline (usual care); Phase 2: Two months of nocturnal
      seizure monitoring at home, using Nightwatch and the remote SDD.

      Main study parameters/endpoints: The diagnostic performance of Nightwatch and the remote SDD
      algorithms, i.e. sensitivity, positive predictive value, false alarm rate and % time with
      uninterrupted signal output. The investigators will evaluate feasibility of Nightwatch
      through surveys on quality of life, sleep, parental strain, interviews with parents/guardians
      and neurologists, and a value sensitive design group session. The investigators will also
      perform a cost-effectiveness and cost-utility analysis by medical consumption and costs
      questionnaires.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Implementing SDDs will not pose any direct or substantial risk. Study
      participation can be a burden though, due to impact of the devices on privacy, number of
      false alarms and time spent on the questionnaires and interviews. Application of the SDDs,
      however, might offer better insight into the actual number of nocturnal seizures in a child,
      change in medical management and facilitate appropriate interventions in major motor
      seizures. If reliable, SDDs may improve the night rest of both patient and parents/guardians.
    

Intervention name(s): Nightwatch
Intervention type(s): Device
Intervention description(s): Nocturnal monitoring for 2 months with three different seizure detection devices.
Other intervention name(s): Video and audio detection
Intervention model: Single Group Assignment
Intervention model description: Phase 1: Usual care (2 months), Phase 2: Intervention with monitoring true different devices (2 months), Phase 3: Optional phase with continued use of Nightwatch or tailoring.
Masking: None (Open Label)
Primary purpose: Diagnostic