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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-11-17

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.

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Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AI-Flex

Intervention Type DEVICE

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.

Interventions

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AI-Flex

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.

Intervention Type DEVICE

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.