Implementing Artificial-intelligence Wristbands to Help in Recording Seizures
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
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
PEIYUAN F. HSIEH
Principal Investigator
Taichung Veterans General Hospital
