Verily Clinical Study Watch Analytical Validation Study

August 29, 2023 updated by: Verily Life Sciences LLC
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Up to 100 participants will be enrolled. This is a decentralized study across the United States.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of resting pulse rate
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verily Life Sciences LLC

Investigators

  • Principal Investigator: Scooter Plowman, MD, Verily Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 104126

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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