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

NCT05581290 | Completed

• 1 other identifier: 22-005307
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease

Keywords

Underlying Cardiac Structural Condition

Outcome Measures

Primary Outcomes (3)

• AI-Flex ECG Accuracy

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

  Baseline

• AI-Flex Temperature Measurement Accuracy

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

  Baseline

• AI-Flex PPG Measurement Accuracy

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

  Baseline

Study Arms (1)

Multi-Modal Sensor Patch Measurements

EXPERIMENTAL

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.

Device: AI-Flex

Interventions

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.

Multi-Modal Sensor Patch Measurements

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- \< 18 years of age or \> 85 years of age.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Imon Banerjee

Phoenix, Arizona, 85054-4533, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Imon Banerjee, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: November 17, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)