Verily Clinical Study Watch Analytical Validation Study

Chronic Disease Clinical Trial

Official title:

Verily Clinical Study Watch Analytical Validation Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05534477
• Other study ID #: 104126
• Status: Enrolling by invitation
• Start date: September 18, 2023
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Healthy Population

Intervention

Device:
• Verily 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.
• Vivalink 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.
• Modus 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.

Locations

Country	Name	City	State
United States	Verily Life Sciences	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.