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BodyGuardian Respiration and Activity Validation Testing

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ClinicalTrials.gov Identifier: NCT02255526
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Healthy 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)

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BodyGuardian Respiration and Activity Validation Testing
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : July 2016

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




Primary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers and Heart Failure patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255526


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Preventice
Mayo Clinic
Investigators
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Principal Investigator: Bruce Johnson, Ph.D. Mayo Clinic, Rochester, MN
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Responsible Party: Preventice
ClinicalTrials.gov Identifier: NCT02255526    
Other Study ID Numbers: 14-004034
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not an applicable study under section 801