Verily Clinical Study Watch Analytical Validation Study

N/AActive Not RecruitingNCT05534477

Verily Life Sciences LLC100 enrolled

Overview

This study is designed to evaluate the performance of the Verily Clinical Study Watch for the quantification of participants' movement and pulse rate when the wearer is at rest.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Healthy Population Chronic Disease

Interventions

Verily Clinical Study WatchDEVICE

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.

Vivalink ECG PatchDEVICE

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.

Modus StepWatch 4DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is ≥ 22 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 owns 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 has tremor or significant life-threatening arrhythmia * Participant is allergic to nickel or metal jewelry * Participant has a known severe allergy to polyester, nylon, or spandex * Participant has a known allergic reaction to adhesives or hydrogels * Participant has a tattoo covering the area where the watch face would rest on either wrist * Participant has planned international travel during the study

Locations (1)

Verily Life Sciences

South San Francisco, California, United States

Outcomes

Primary Outcomes

Accuracy of pulse rate when wearer is at rest

To evaluate the accuracy of the Verily Clinical Study Watch's ability to measure pulse rate when wearer is at rest during unsupervised free-living conditions. Pulse rate measurements will be compared against heart rate output from the reference device (FDA cleared ECG patch).

Time frame: 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.

Sensitivity of movement detection

To evaluate the accuracy of the Verily Clinical Study Watch's ability to detect movement (rest vs not rest) during supervised conditions. Movement detection will be compared against virtual supervised observer-reference labels of rest vs not rest.

Time frame: 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.

Specificity of movement detection

Time frame: 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.

Data from ClinicalTrials.gov

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