Clinical trial NCT02255526: BodyGuardian Respiration and Activity Validation Testing
Official title: BodyGuardian Respiration and Activity Validation Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Preventice
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2014-10-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and Heart Failure patients

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)

Eligibility 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.

Primary outcomes:
measure: Number of successful breathing and activity measurements recorded by BG
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Bruce Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: