Performance Assessment of a Remote Patient Monitoring Device

NCT02570906 | Completed

• 1 other identifier: COVMOPO0517
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physiologic Monitoring

Outcome Measures

Primary Outcomes (6)

• Heart rate accuracy

  No follow-up visits will occur

  On the day of enrollment to completion of one-time study visit

• Heart rate precision

  No follow-up visits will occur

  On the day of enrollment to completion of one-time study visit

• Respiratory rate accuracy

  No follow-up visits will occur

  On the day of enrollment to completion of one-time study visit

• Respiratory rate precision

  No follow-up visits will occur

  On the day of enrollment to completion of one-time study visit

• Activity

  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)

  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

Interventions

Zephyr BioPatch DEVICE

Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers, Adults 18 to 50 years old

You may qualify if:

• Signed and dated informed consent by subject or legally authorized representative (LAR)
• Male or female of any race
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

• William Whang, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: October 7, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

US (1)