Skip to main content
OpenTrials
Completed

NCT Number: NCT05581290

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imon Banerjee

Phoenix, Arizona, 85054-4533, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Flex

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.

Primary outcomes

  1. AI-Flex ECG Accuracy

    Time frame: Baseline

    Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording

  2. AI-Flex Temperature Measurement Accuracy

    Time frame: Baseline

    Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement

  3. AI-Flex PPG Measurement Accuracy

    Time frame: Baseline

    Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.