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

NCT05581290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-05-23

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Disease

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • Imon Banerjee, PhD · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2023-11-17
Completion
2023-11-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581290 on ClinicalTrials.gov