Performance Assessment of a Remote Patient Monitoring Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-02-29

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.

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Detailed Description

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Conditions

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Physiologic Monitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Zephyr BioPatch

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes