Promoting Implementation of Seizure Detection Devices in Epilepsy Care

NCT03909984 | Completed DMC

• 1 other identifier: NL62995.041.17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• Diagnostic performance Nightwatch - sensitivity

  Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of sensitivity.

  Monitoring period of 2 months per participant.

• Diagnostic performance Nightwatch - positive predictive value

  Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of positive predictive value.

  Monitoring period of 2 months per participant.

• Diagnostic performance Nightwatch - false alarm rate

  Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of false alarm rate.

  Monitoring period of 2 months per participant.

• Diagnostic performance Nightwatch - % time with uninterrupted signal

  Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of % of time with uninterrupted signal output.

  Monitoring period of 2 months per participant.

Secondary Outcomes (10)

• Diagnostic performance of video and audio detection - sensitivity

  Monitoring period of 2 months per participant.

• Diagnostic performance of video and audio detection - positive predictive value

  Monitoring period of 2 months per participant.

• Diagnostic performance of video and audio detection - false alarm rate

  Monitoring period of 2 months per participant.

• Diagnostic performance of video and audio detection - % time with uninterrupted signal output.

  Monitoring period of 2 months per participant.

• Feasibility of Nightwatch will be examined in an interview with parents/guardians, focussing on different aspects of the device.

  4 month period (2 months usual care + 2 months monitoring)

Study Arms (1)

Intervention

OTHER

All participants will be monitored for 2 months.

Device: Nightwatch

Interventions

Nightwatch DEVICE

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

Also known as: Video and audio detection

Intervention

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-16 years
• Diagnosis of refractory epilepsy with ≥1 major nocturnal seizure per week.
• Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
• Written informed consent by legal representatives (mostly parents) and also by the subject when aged ≥12 years and capable of signing informed consent.

You may not qualify if:

• Intensive non-epileptic movement patterns such as severe choreatiform movements, intensive sleep walking, or frequent night terrors (\> 1/week).
• Minor motor seizures only, i.e. non-generalized or short (\< 10 sec.) tonic seizures or isolated myoclonias that are self-limited and do not require intervention.
• Presence of a pacemaker or cardiac arrhythmias that may generate false alarms (e.g. supraventricular tachycardia).
• Inability to comply to the trial procedure.
• Skin characteristics (e.g. tattoo) that may affect photoplethysmography and thereby influence performance of the Nightwatch.
• Dependence on another SDD (e.g. Emfit or saturation monitor). Simultaneous use of a baby phone (or other types of microphones) is permitted.
• Subjects who are not sleeping alone in the bed (i.e. co-sleeping in the parents'/guardians' bed influences the remote SDD). Subjects and parents/guardians are not allowed to change their sleeping habits for the duration of the study only.

Sponsors & Collaborators

• Stichting Epilepsie Instellingen Nederland: lead
• Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care: collaborator
• UMC Utrecht: collaborator

Study Sites (3)

Stichting Epilepsie Instellingen Nederland (SEIN)

Heemstede, Achterweg 5, 2103 SW, Netherlands

Location

Academic Center of Epileptology Kempenhaeghe

Heeze, 5591 VE, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• van Westrhenen A, Lazeron RHC, van Dijk JP, Leijten FSS, Thijs RD; Dutch TeleEpilepsy Consortium. Multimodal nocturnal seizure detection in children with epilepsy: A prospective, multicenter, long-term, in-home trial. Epilepsia. 2023 Aug;64(8):2137-2152. doi: 10.1111/epi.17654. Epub 2023 Jun 14.

  PMID: 37195144 DERIVED

Study Officials

• Anouk van Westrhenen, MD

  Stichting Epilepsie Instellingen Nederland

  PRINCIPAL INVESTIGATOR

• Roland D Thijs, MD, PhD

  Stichting Epilepsie Instellingen Nederland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: April 10, 2019
• Study Start: April 26, 2018
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

NL (3)