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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05581290

Enrollment

Registered

2022-10-14

Start date

2022-11-17

Completion date

2023-11-17

Last updated

2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Underlying Cardiac Structural Condition

Brief 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.

Interventions

DEVICEAI-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026