Verily Clinical Study Watch Analytical Validation Study

NCT05534477 | Active Not Recruiting FDA Device

• 1 other identifier: 104126
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Population; Chronic Disease

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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

  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.

  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.

Interventions

Verily Clinical Study Watch DEVICE

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 Patch DEVICE

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 4 DEVICE

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (1)

Verily Life Sciences

South San Francisco, California, 94080, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scooter Plowman, MD

  Verily Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 9, 2022
• Study Start: September 18, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)