Performance Assessment of a Remote Patient Monitoring Device

Study Overview
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Brief Summary
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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.

Official Title
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A Performance Assessment of a Remote Patient Monitoring Device in Measuring Heart Rate, Respiration Rate, Posture, and Activity Level

Conditions
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Physiologic Monitoring

Intervention / Treatment
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* Device: Zephyr BioPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Zephyr BioPatch|Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |