AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- AI-Flex Temperature Measurement Accuracy
研究概览
简要总结
The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be referred for Cardiology Clinic Visit.
- •Subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission
- •Subject must be 18 - 85 years of age.
排除标准
- •- < 18 years of age or > 85 years of age.
研究组 & 干预措施
Multi-Modal Sensor Patch Measurements
Subjects referred to Mayo Clinic in Arizona Cardiology Clinic who have an underlying cardiac structural condition will have a 15-minute data collection via the prototype device, AI-Flex, and standard of care electrocardiogram (ECG), temperature, and photoplethysmogram (PPG) measurements.
干预措施: AI-Flex (Device)
结局指标
主要结局
AI-Flex Temperature Measurement Accuracy
时间窗: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement
AI-Flex ECG Accuracy
时间窗: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording
AI-Flex PPG Measurement Accuracy
时间窗: Baseline
Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement
次要结局
未报告次要终点
研究者
Imon Banerjee
Principal Investigator
Mayo Clinic
