Physiologic MonitoringNCT02570906
Performance Assessment of a Remote Patient Monitoring Device
An observational study of Physiologic Monitoring, run by Medtronic - MITG at 1 site in United States.
Trial summary
This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate, respiration rate, posture, and activity level compared to reference devices in healthy adult subjects during a variety of situations including hospital room movements, talking, and a short bout of exercise. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiologic Monitoring
- What is being tested?
- Zephyr BioPatch
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers, Adults 18 to 50 years old
Who may be able to join
- Signed and dated informed consent by subject or legally authorized representative (LAR)
- Male or female of any race
- 18-50 years of age, inclusive
- Willingness to have study devices attached during study participation
- Willingness to participate in all aspects of the study
- Ability to walk without human assistance or walking aides (e.g. cane or walker), in the opinion of the investigator
Who cannot join
- Subject is unable to provide informed consent
- Under 18 years of age or over 50 years of age
- Implanted pacemaker or defibrillator
- Diagnosis of atrial fibrillation as reported by the subject
- Current hospital admission
- History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
Show all 11Show fewer
- Any contraindications to protocol specific repositioning techniques (e.g. turning on right side or left side or lying in supine position)
- Female subject is pregnant and/or lactating as reported by the subject
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Subject is on any medications, in the opinion of the investigator, that would impair heart response during the short bout of exercise
- A serious concurrent medical or other condition, in the opinion of the investigator, that would impair protocol compliance or safety of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level
This study will evaluate the performance of the Zephyr BioPatch in measuring heart rate, respiration rate, posture, and activity level compared to reference devices in healthy adult subjects during a variety of situations including hospital room movements, talking, and a short bout of exercise.
- Conditions
- Physiologic Monitoring
- Being tested
- Zephyr BioPatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zephyr BioPatchDevice
Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate accuracy
No follow-up visits will occur
Measured: On the day of enrollment to completion of one-time study visit
Heart rate precision
No follow-up visits will occur
Measured: On the day of enrollment to completion of one-time study visit
Respiratory rate accuracy
No follow-up visits will occur
Measured: On the day of enrollment to completion of one-time study visit
Respiratory rate precision
No follow-up visits will occur
Measured: On the day of enrollment to completion of one-time study visit
Activity
Activity will be classified as lying, upright, walking, or running.
Measured: On the day of enrollment to completion of one-time study visit
Body orientation (position)
Body orientation (position) if lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
Measured: On the day of enrollment to completion of one-time study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologic MonitoringStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Whang, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570906
- Sponsor's protocol ID
- COVMOPO0517
- Status last verified
- Feb 2016
- First submitted
- 1 Sep 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level
- ClinicalTrials.gov ID
- NCT02570906
- Acronym / sponsor ID
- COVMOPO0517
- Conditions
- Physiologic Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Oct 2015 (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 study will evaluate the performance of the Zephyr BioPatch in measuring heart rate, respiration rate, posture, and activity level compared to reference devices in healthy adult subjects during a variety of situations including hospital room movements, talking, and a short bout of exercise.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers, Adults 18 to 50 years old
Key inclusion criteria (6 listed)
- Signed and dated informed consent by subject or legally authorized representative (LAR)
- Male or female of any race
- 18-50 years of age, inclusive
- Willingness to have study devices attached during study participation
- Willingness to participate in all aspects of the study
Key exclusion criteria (11 listed)
- Subject is unable to provide informed consent
- Under 18 years of age or over 50 years of age
- Implanted pacemaker or defibrillator
- Diagnosis of atrial fibrillation as reported by the subject
- Current hospital admission
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 |
|---|---|---|
| Zephyr BioPatchRemote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™) | Device | – |
Primary outcome
Heart rate accuracy
Time frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
Heart rate precision
Time frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
Respiratory rate accuracy
Time frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
Respiratory rate precision
Time frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
Activity
Time frame: On the day of enrollment to completion of one-time study visit
Activity will be classified as lying, upright, walking, or running.
Body orientation (position)
Time frame: On the day of enrollment to completion of one-time study visit
Body orientation (position) if lying horizontally will be classified as facing right, facing left, facing down (prone), or facing up (supine).
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 26 Feb 2016.
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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.
William Whang, MD principal investigator
Columbia University
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 Physiologic Monitoring, run by Medtronic - MITG 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 6 inclusion and 11 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 26 Feb 2016. 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?
Heart rate accuracy (time frame: On the day of enrollment to completion of one-time study visit). The study lists 6 primary outcomes in all. 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 26 Feb 2016.