BodyGuardian Respiration and Activity Validation Testing

Completed

• Conditions: Healthy
• Interventions: Device: BodyGuardian

• Registration Number: NCT02255526
• Lead Sponsor: Preventice

Brief Summary

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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Primary Completion: 2015-09
• Study Completion: 2016-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure	BodyGuardian	Heart failure patients between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.
Healthy Volunteers	BodyGuardian	Healthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.

Primary Outcome Measures

Name	Time	Method
Number of successful breathing and activity measurements recorded by BG	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).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States