跳至主要内容
临床试验/NCT05581290
NCT05581290已完成不适用

AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年11月17日最近更新:
适应症
干预措施

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

Experimental

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Imon Banerjee

Principal Investigator

Mayo Clinic

研究点 (1)

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