Back to resultsA Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference
Primary Purpose
Cardiac Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI-Flex
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Disease focused on measuring Underlying Cardiac Structural Condition
Eligibility Criteria
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.
Sites / Locations
- Imon BanerjeeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi-Modal Sensor Patch Measurements
Arm 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.
Outcomes
Primary Outcome Measures
AI-Flex ECG Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording
AI-Flex Temperature Measurement Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement
AI-Flex PPG Measurement Accuracy
Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05581290
Brief Title
A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference
Official Title
AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Underlying Cardiac Structural Condition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-Modal Sensor Patch Measurements
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
AI-Flex
Intervention Description
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.
Primary Outcome Measure Information:
Title
AI-Flex ECG Accuracy
Description
Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording
Time Frame
Baseline
Title
AI-Flex Temperature Measurement Accuracy
Description
Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement
Time Frame
Baseline
Title
AI-Flex PPG Measurement Accuracy
Description
Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imon Banerjee, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imon Banerjee
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054-4533
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imon Banerjee, PhD
Phone
480-574-2259
Email
Banerjee.Imon@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference
We'll reach out to this number within 24 hrs