Promoting Implementation of Seizure Detection Devices in Epilepsy Care: the PROMISE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Diagnostic performance Nightwatch - false alarm rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diagnostic performance Nightwatch - false alarm rate
时间窗: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of false alarm rate.
Diagnostic performance Nightwatch - sensitivity
时间窗: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of sensitivity.
Diagnostic performance Nightwatch - % time with uninterrupted signal
时间窗: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of % of time with uninterrupted signal output.
Diagnostic performance Nightwatch - positive predictive value
时间窗: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of positive predictive value.
次要结局
- Diagnostic performance of video and audio detection - sensitivity(Monitoring period of 2 months per participant.)
- Feasibility of Nightwatch by means of Caregiver Strain Index (CSI).(4 month period (2 months usual care + 2 months monitoring))
- Cost-utility analysis of Nightwatch(4 month period (2 months usual care + 2 months monitoring))
- 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))
- Diagnostic performance of video and audio detection - false alarm rate(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 - % time with uninterrupted signal output.(Monitoring period of 2 months per participant.)
- Feasibility of Nightwatch by means of the Quality of Life questionnaire: EQ-5D-5L(4 month period (2 months usual care + 2 months monitoring))
- Cost-effectiveness analysis of Nightwatch(4 month period (2 months usual care + 2 months monitoring))
- Feasibility of Nightwatch by means of Pittsburgh Sleep Quality Index (PSQI).(4 month period (2 months usual care + 2 months monitoring))