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Active, not recruitingNCT05534477Updated Apr 11, 2025

Verily Clinical Study Watch Analytical Validation Study

An observational study in Healthy Population and Chronic Disease, sponsored by Verily Life Sciences LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by Verily Life Sciences LLC · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy Population
  • Chronic Disease

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03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's planned enrollment of 100 is below the median of 419 across 249 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Verily Life Sciences LLC is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • DeviceVerily 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.

  • DeviceVivalink 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.

  • DeviceModus 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.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

    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.

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Study locations

1 site
  • Verily Life Sciences
    South San Francisco, California 94080, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05534477
Lead sponsor
Verily Life Sciences LLC
Responsible party
Sponsor
First posted
Sep 9, 2022
Start date
Sep 18, 2023
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Apr 11, 2025

Study contacts

Scooter Plowman, MD
principal investigator · Verily Life Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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