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

Not Applicable

Completed

• Conditions: Cardiac Disease
• Interventions: Device: AI-Flex

• Registration Number: NCT05581290
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Study Start: 2022-11-17
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi-Modal Sensor Patch Measurements	AI-Flex	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Imon Banerjee; 🇺🇸 Phoenix, Arizona, United States