HealthyNCT02255526
BodyGuardian Respiration and Activity Validation Testing
An observational study of Healthy, run by Preventice at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BodyGuardian
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and Heart Failure patients
Who may be able to join
- Healthy Volunteers between the ages of 18-80
- Heart Failure Patients/ Volunteers between the ages of 18-80
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Healthy
- Being tested
- BodyGuardian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyGuardianDevice
BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels. Receives: 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. Receives: Device: BodyGuardian |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Preventice
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Bruce Johnson, Ph.D., Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255526
- Sponsor's protocol ID
- 14-004034
- Status last verified
- Apr 2017
- First submitted
- 26 Sep 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not an applicable study under section 801
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BodyGuardian Respiration and Activity Validation Testing
- ClinicalTrials.gov ID
- NCT02255526
- Acronym / sponsor ID
- 14-004034
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PreventiceIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: BodyGuardianHealthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels. |
| Heart Failure | – | Device: BodyGuardianHeart failure patients between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and Heart Failure patients
Key inclusion criteria (2 listed)
- Healthy Volunteers between the ages of 18-80
- Heart Failure Patients/ Volunteers between the ages of 18-80
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyGuardianBodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG | Device | Healthy Volunteers, Heart Failure |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No. Not an applicable study under section 801
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Johnson, Ph.D. principal investigator
Mayo Clinic, Rochester, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Preventice at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful breathing and activity measurements recorded by BG (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017; AzTrials last refreshed its copy on 4 Nov 2026.