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Promoting Implementation of Seizure Detection Devices in Epilepsy Care

NCT03909984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-18

No results posted yet for this study

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.

Conditions

  • Epilepsy in Children

Interventions

DEVICE

Nightwatch

Nocturnal monitoring for 2 months with three different seizure detection devices.

Sponsors & Collaborators

  • Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Stichting Epilepsie Instellingen Nederland

    lead OTHER

Principal Investigators

  • Anouk van Westrhenen, MD · Stichting Epilepsie Instellingen Nederland

  • Roland D Thijs, MD, PhD · Stichting Epilepsie Instellingen Nederland

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2021-04-08
Completion
2021-04-08

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909984 on ClinicalTrials.gov