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

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581290
• Other study ID #: 22-005307
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: November 17, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Imon Banerjee	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials