A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Disease

Intervention / Treatment
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* Device: AI-Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: - < 18 years of age or > 85 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Modal Sensor Patch Measurements<br>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. | Device: AI-Flex<br>* A flexible multi-modal bio-sensing device with integrated AI capability used to measure ECG (heart's electrical activity), body temperature, and PPG (blood volume in tissue); primarly mounted on the wrist and chest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AI-Flex ECG Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording | Baseline | 
| AI-Flex Temperature Measurement Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement | Baseline | 
| AI-Flex PPG Measurement Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Underlying Cardiac Structural Condition