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临床试验/NCT04505852
NCT04505852Unknown不适用

Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Satisfaction score of seizure wristband

研究概览

简要总结

The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace

详细描述

Currently, seizure tracking relies on subjective patient and family recall. In several studies patients report only approximately half of their seizures, and even less during sleep.

Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or autonomic nervous system dysfunction.

Wristband sensors help caregivers assist patients during seizures and may reduce risks for complications such as injuries and SUDEP.

Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.

The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of 93.1%. The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least one seizure per month in the 3-month period before entering the study

排除标准

  • •Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet <80,000/μL, neutrophil <1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease (except anxiety).

研究组 & 干预措施

EMBRACE USERS

Experimental

Embrace wristband users

干预措施: Embrace (Device)

结局指标

主要结局

Satisfaction score of seizure wristband

时间窗: Through study completion, an average of 1 year

Scores 1(least satisfied) to 10 (most satisfied)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PEIYUAN F. HSIEH

Principal Investigator

Taichung Veterans General Hospital

研究点 (1)

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