Verily Clinical Study Watch Analytical Validation Study

Active, not recruiting

• Conditions: Chronic Disease; Healthy Population

• Registration Number: NCT05534477
• Lead Sponsor: Verily Life Sciences LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-09
• Study Start: 2023-09-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of pulse rate when wearer is at 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.	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).
Sensitivity of movement detection	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.
Specificity of movement detection	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.

Trial Locations

Locations (1)

Verily Life Sciences; 🇺🇸 South San Francisco, California, United States