Verily Clinical Study Watch Analytical Validation Study

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

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2025-06-30

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' movement and pulse rate when the wearer is at rest.

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Detailed Description

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Conditions

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Healthy Population Chronic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes