Verily Clinical Study Watch Analytical Validation Study

Study Overview
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Brief Summary
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This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' daily ambulatory minutes, daily step count, resting pulse rate, and overnight pulse rate variability in comparison to reference devices.

Official Title
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Verily Clinical Study Watch Analytical Validation Study

Conditions
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Healthy Population

Intervention / Treatment
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* Device: Verily Clinical Study Watch
* Device: Verily Study Watch
* Device: Vivalink ECG Patch
* Device: Modus StepWatch 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥ 18 and ≤ 80 years old Participant understands the study requirements and is able and willing to provide written informed consent Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator Participant is able to walk without the use of an assistive device (cane, crutch, walker, etc) Participant does not have significant cardiovascular medical history (e.g., chronic heart failure or arrhythmias, including atrial fibrillation, bradycardia, tachycardia, arrhythmia) Own a smartphone with a data plan and be the primary user of the smartphone; smartphone must be compatible with the applications used in the study Participant is a US Resident Exclusion Criteria: Participant is allergic to nickel or metal jewelry Known severe allergy to polyester, nylon, or spandex Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies Participant cannot make arm swings with either arm or is in a situation that prevents arm swings completely with either arm Participants who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or other implantable medical electronic device Participant has a tattoo covering the area where the watch face would rest on either wrist Planned international travel during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Verily Clinical Study Watch|The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.|
|Device: Verily Study Watch|The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.|
|Device: Vivalink ECG Patch|The Vivalink ECG Patch is a continuously recording ECG monitor and will be used as a reference device for measuring participants' pulse rate, pulse rate variability, and pulse rate coverage. The Vivalink ECG Patch is a medical device manufactured by VivaLNK Inc. and has been cleared by the FDA.|
|Device: Modus StepWatch 4|Modus StepWatch 4 is an ankle-worn wearable medical device, and will be used as a reference device for measuring participants' ambulatory time and daily step count. The Modus StepWatch 4 is FDA listed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of resting pulse rate | To evaluate the accuracy of the Verily Clinical Study Watch's cloud-based algorithms of Resting Pulse Rate (bpm) based on sensor data collected by the Verily Clinical Study Watch against the same metrics derived from the data collected by reference devices (FDA cleared ECG patch) in unsupervised free-living conditions. | Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period. | 
| Accuracy of daily step count | To evaluate the accuracy of the Verily Clinical Study Watch's cloud-based algorithms of Daily Step Count (steps) based on sensor data collected by the Verily Clinical Study Watch against the same metrics derived from the data collected by reference devices (FDA-listed ankle-worn accelerometer) in unsupervised free-living conditions. | Approximately 14-day at-home observational period with two virtual visits, one at the beginning and the other at the end of the at-home period. |