BodyGuardian Respiration and Activity Validation Testing

This project will compare BodyGuardian (BG) device measurements of breathing and activity levels to the gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and gas analyzers measures for breathing and metabolic rate (indirect calorimetry) for activity, We are hopeful these comparisons will help us improve upon the measurements being made in the current version of the BG device.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: BodyGuardian

Detailed Description

BodyGuardian remote monitoring system is an FDA 510 cleared device used to perform remote monitoring of cardiac patients. BodyGuardian (BG) is a novel remote care platform. It incorporates an adhesive strip sensor with in-built electrodes attached to a rechargeable module that can determine an ECG signal and bio impedance. The module also has a 3-way accelerometer. ECG, physical activity and respiration can be assessed using these sensors. Although ECG data is reliable, there are doubts regarding the clinical meaning and validity of the activity and respiration data.

The BG reports respiration rate and activity level (on a scale of 0 to 100). This data is being used as input into other clinical algorithms including onboard ECG arrhythmia detection as well as clinical care algorithms for heart failure decompensation prediction.

Respiration data is not uniformly reported and there is still doubt regarding its validity. BG breathing measurements will be compared to gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and gas analyzer. Activity data is reported but the investigators do not know how the value translates into clinically used objective parameters of activity e.g. METS. BG activity measurements will be compared to the gold standard activity measurements using metabolic rate (indirect calorimetry)

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and Heart Failure patients

Description

Inclusion Criteria:

• Healthy Volunteers between the ages of 18-80
• Heart Failure Patients/ Volunteers between the ages of 18-80

Exclusion Criteria:

• Healthy - Non Ambulatory. With Pacemaker. Not able to sign consent.
• Hospitalized in last 6 months for fractures, myocardial infarcts, cancer related surgery, chemo therapy. Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy
• Heart Failure - Non Ambulatory. With Pacemaker. Not able to sign consent.
• Hospitalized in last 6 months for fractures, cancer related surgery, chemo therapy.
• Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Healthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.	Device: BodyGuardian; BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG
Heart Failure; Heart failure patients between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.	Device: BodyGuardian; BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of successful breathing and activity measurements recorded by BG	Measurements of BG breathing (rate and patterns) with impedance and accelerometry compared to gold standards using a mouthpiece connected to flow and gas exchange analyzers. BG activity level measurements based on accelerometry compared to gold standard measures of metabolic rate (indirect calorimetry).	1 year

Collaborators and Investigators

• Sponsor: Preventice
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Bruce Johnson, Ph.D., Mayo Clinic, Rochester, MN

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14-004034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not an applicable study under section 801