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

Mayo Clinic

Status: Completed

Conditions: Cardiac Disease

Treatments: Device: AI-Flex

Study type: Interventional

Funder types: Other

Identifiers

NCT05581290

22-005307

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Multi-Modal Sensor Patch Measurements

Experimental group

Description:

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.

Treatment:

Device: AI-Flex