Promoting Implementation of Seizure Detection Devices in Epilepsy Care (PROMISE)

Promoting Implementation of Seizure Detection Devices in Epilepsy Care: the PROMISE Study

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy in Children
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Heeze, Netherlands, 5591 VE
    • Academic Center of Epileptology Kempenhaeghe
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht
  • Achterweg 5
    • Heemstede, Achterweg 5, Netherlands, 2103 SW
      • Stichting Epilepsie Instellingen Nederland (SEIN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Intervention; All participants will be monitored for 2 months.	Device: Nightwatch; Nocturnal monitoring for 2 months with three different seizure detection devices.; Other Names: Video and audio detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of video and audio detection - sensitivity	Diagnostic performance of our remote seizure detection devices (video and audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of sensitivity.	Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - positive predictive value	Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of positive predictive value.	Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - false alarm rate	Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of false alarm rate.	Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - % time with uninterrupted signal output.	Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of % 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.	Feasibility of Nightwatch with a mixed methods approach focusing on Acceptability, Demand, Implementation, Practicality, Expansion, Limited-efficacy testing, impact of the SDD on parents/guardians with children (interview).	4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Caregiver Strain Index (CSI).	Effect of Nightwatch on parental stress, with a stress questionnaire (CSI), containing 13 questions about stress with 'yes/no' answers. 11-13 tims 'yes' indicates high level of stress, 7-10 times 'yes' indicates medium level of stress and 0-6 times 'yes' means low level of stress.	4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Pittsburgh Sleep Quality Index (PSQI).	Effect of Nightwatch on parental sleep with a sleep questionnaire (PSQI), containing 10 questions about sleep, with scales from 1-4 to indicate how often parents/guardians experience certain sleep problems.	4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of the Quality of Life questionnaire: EQ-5D-5L	Effect of Nightwatch on parental quality of life, with a QoL questionnaire (EQ-5D-5L), containing 5 questions about the person's health with a 1-5 scale indicating the severity of a certain health problem and a 0-100 rating scale of their health.	4 month period (2 months usual care + 2 months monitoring)
Cost-effectiveness analysis of Nightwatch	Economic evaluation from a societal prospective of Nightwatch involving a cost-effectiveness analysis (CEA).	4 month period (2 months usual care + 2 months monitoring)
Cost-utility analysis of Nightwatch	Economic evaluation from a societal prospective of Nightwatch involving a cost- a cost-utility analysis (CUA).	4 month period (2 months usual care + 2 months monitoring)

Collaborators and Investigators

• Sponsor: Stichting Epilepsie Instellingen Nederland
• Collaborators: UMC Utrecht; Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care
• Investigators: Principal Investigator: Anouk van Westrhenen, MD, Stichting Epilepsie Instellingen Nederland; Study Director: Roland D Thijs, MD, PhD, Stichting Epilepsie Instellingen Nederland

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2018
• Primary Completion (ACTUAL): April 8, 2021
• Study Completion (ACTUAL): April 8, 2021

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: NL62995.041.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Principal investigators will share necessary information on participants and enrollment.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No