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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BodyGuardian

Device

BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG

Primary outcomes

Number of successful breathing and activity measurements recorded by BG

Time frame: 1 year

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).

Sponsors and collaborators

Lead sponsor

Preventice

Industry

Collaborators

Mayo Clinic

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Oct 2, 2014
Registry last updated: Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed