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临床试验/NCT03896386
NCT03896386已完成不适用

Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms: EPIDOGS Digital Seizure Diary

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
227
试验地点
2
主要终点
Sensitivity and specificity across all dogs.

研究概览

简要总结

During a three-month period, the study subjects will be using an electronic diary app that they can download and install on their smartphones to register the occurrence of seizures and also to register the potential alerting behaviour of their dogs. This information will increase the knowledge of the accuracy of these alerts.

详细描述

This is a international study by Ghent University that will initially involve people from Belgium, Italy and the UK.

Previous studies of alerting dog accuracy are either case studies or retrospective studies that rely on memory recall of information about alerting behaviour, with the risk of memory bias that reduces reliability.

The use of electronic diaries has been described as more accurate and has better compliance than paper ones. Nowadays, electronic diaries offer the possibility of receiving live information and/or timed answers, thereby increasing compliance and decreasing the incidence of memory bias. This would be the first time that "real time" information about dog behaviour and seizures in the same patients is collected systematically. This will facilitate the analysis of the specificity and sensitivity of alerting behaviour as perceived by the owner.

During a three-month period, systematic data on the occurrence of seizures in the patient and on alerting behaviour by the dog will be collected. This information will increase the knowledge of the type of alerting behaviours that the dogs display and will allow to calculate the specificity and sensitivity of dog behaviour interpreted by the owner as predictive of a seizure. Depending on availability of trained and untrained dogs, possible differences in the alerting behaviour between both types of dogs and in their alerting specificity/sensitivity will be studied.To avoid recall bias the information will be received live through a back-end.

To be able to participate, the volunteers will grant the investigators permission, via the informed consent, to contact their neurologist to confirm their epilepsy diagnosis and to send monthly reports of the electronic diary (see below) to their neurologist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The volunteer has been diagnosed with epilepsy by a neurologist and lives with a dog that anticipates the occurrence of seizures (trained or not)
  • Volunteers should be able to operate an electronic diary app on a smartphone by themselves or will have an assistant/carer with them 24/24 that will operate the device for them.
  • In the case of children, the parents/tutors will fill in the diary for them.
  • In the case of people with learning disabilities, carers or familiars will fill in the diary for them.

排除标准

  • People with non-epileptic seizures, that are not able to use a smartphone's app or that can't provide us with a confirmation of their diagnosis.

结局指标

主要结局

Sensitivity and specificity across all dogs.

时间窗: 3 months

Percentage of dog alerts followed by a seizure, percentage of seizures preceded by a dog alert

次要结局

  • Differences between trained and untrained dogs(3 months)
  • Correlation between alerting behaviour and pre-ictal symptoms(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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