Clinical trial NCT03909984: Promoting Implementation of Seizure Detection Devices in Epilepsy Care
Official title: Promoting Implementation of Seizure Detection Devices in Epilepsy Care: the PROMISE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy in Children
Lead sponsor: Stichting Epilepsie Instellingen Nederland
Sponsor class: OTHER
Collaborators: name: Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care
name: UMC Utrecht
First posted: 2019-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance Nightwatch - sensitivity
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance Nightwatch - positive predictive value
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance Nightwatch - false alarm rate
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance Nightwatch - % time with uninterrupted signal
timeFrame: Monitoring period of 2 months per participant.
Secondary outcomes:
measure: Diagnostic performance of video and audio detection - sensitivity
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance of video and audio detection - positive predictive value
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance of video and audio detection - false alarm rate
timeFrame: Monitoring period of 2 months per participant.
measure: Diagnostic performance of video and audio detection - % time with uninterrupted signal output.
timeFrame: Monitoring period of 2 months per participant.
measure: Feasibility of Nightwatch will be examined in an interview with parents/guardians, focussing on different aspects of the device.
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
measure: Feasibility of Nightwatch by means of Caregiver Strain Index (CSI).
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
measure: Feasibility of Nightwatch by means of Pittsburgh Sleep Quality Index (PSQI).
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
measure: Feasibility of Nightwatch by means of the Quality of Life questionnaire: EQ-5D-5L
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
measure: Cost-effectiveness analysis of Nightwatch
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
measure: Cost-utility analysis of Nightwatch
timeFrame: 4 month period (2 months usual care + 2 months monitoring)
Other outcomes:
Locations:
city: Heemstede
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland (SEIN)
state: Achterweg 5
city: Heeze
country: Netherlands
facility: Academic Center of Epileptology Kempenhaeghe
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Stichting Epilepsie Instellingen Nederland
name: Anouk van Westrhenen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stichting Epilepsie Instellingen Nederland
name: Roland D Thijs, MD, PhD
role: STUDY_DIRECTOR
References: