BodyGuardian Respiration and Activity Validation Testing

NCT02255526 | Completed

• 1 other identifier: 14-004034
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

BodyGuardian DEVICE

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

Healthy Volunteers; Heart Failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and Heart Failure patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Preventice: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Bruce Johnson, Ph.D.

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 2, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)