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Active, Not Recruiting

NCT Number: NCT05534477

Verily Clinical Study Watch Analytical Validation Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Population Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Verily Life Sciences

South San Francisco, California, 94080, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Accuracy of pulse rate when wearer is at 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.

    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).

  2. Sensitivity 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.

    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.

  3. 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.

    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.

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2022
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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