Performance Assessment of a Remote Patient Monitoring Device

February 25, 2016 updated by: Medtronic - MITG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers, Adults 18 to 50 years old

Description

Inclusion Criteria:

  1. Signed and dated informed consent by subject or legally authorized representative (LAR)
  2. Male or female of any race
  3. 18-50 years of age, inclusive
  4. Willingness to have study devices attached during study participation
  5. Willingness to participate in all aspects of the study
  6. Ability to walk without human assistance or walking aides (e.g. cane or walker), in the opinion of the investigator

Exclusion Criteria:

  1. Subject is unable to provide informed consent
  2. Under 18 years of age or over 50 years of age
  3. Implanted pacemaker or defibrillator
  4. Diagnosis of atrial fibrillation as reported by the subject
  5. Current hospital admission
  6. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
  7. Any contraindications to protocol specific repositioning techniques (e.g. turning on right side or left side or lying in supine position)
  8. Female subject is pregnant and/or lactating as reported by the subject
  9. Subject is considered as being morbidly obese (defined as BMI >39.5)
  10. Subject is on any medications, in the opinion of the investigator, that would impair heart response during the short bout of exercise
  11. A serious concurrent medical or other condition, in the opinion of the investigator, that would impair protocol compliance or safety of the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart rate accuracy
Time Frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
On the day of enrollment to completion of one-time study visit
Heart rate precision
Time Frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
On the day of enrollment to completion of one-time study visit
Respiratory rate accuracy
Time Frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
On the day of enrollment to completion of one-time study visit
Respiratory rate precision
Time Frame: On the day of enrollment to completion of one-time study visit
No follow-up visits will occur
On the day of enrollment to completion of one-time study visit
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.
On the day of enrollment to completion of one-time study visit
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).
On the day of enrollment to completion of one-time study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic - MITG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Whang, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVMOPO0517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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