Verily Clinical Study Watch Analytical Validation Study

Healthy Population Clinical Trial

Official title:

Verily Clinical Study Watch Analytical Validation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534477
• Other study ID #: 104126
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Verily Life Sciences LLC
• Contact: Lubna Kazi
• Phone: 650-253-0000
• Email: lkazi[@]verily.com
• 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' daily ambulatory minutes, daily step count, resting pulse rate, and overnight pulse rate variability in comparison to reference devices.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participant is = 18 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 is able to walk without the use of an assistive device (cane, crutch, walker, etc)
• Participant does not have significant cardiovascular medical history (e.g., chronic heart failure or arrhythmias, including atrial fibrillation, bradycardia, tachycardia, arrhythmia)
• Own 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 is allergic to nickel or metal jewelry
• Known severe allergy to polyester, nylon, or spandex
• Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
• Participant cannot make arm swings with either arm or is in a situation that prevents arm swings completely with either arm
• Participants who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator
• Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or other implantable medical electronic device
• Participant has a tattoo covering the area where the watch face would rest on either wrist
• Planned international travel during the study

Related Conditions & MeSH terms

• 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.
• Verily 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 resting pulse rate	To evaluate the accuracy of the Verily Clinical Study Watch's cloud-based algorithms of Resting Pulse Rate (bpm) based on sensor data collected by the Verily Clinical Study Watch against the same metrics derived from the data collected by reference devices (FDA cleared ECG patch) in unsupervised free-living conditions.	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	Accuracy of daily step count	To evaluate the accuracy of the Verily Clinical Study Watch's cloud-based algorithms of Daily Step Count (steps) based on sensor data collected by the Verily Clinical Study Watch against the same metrics derived from the data collected by reference devices (FDA-listed ankle-worn accelerometer) in unsupervised free-living conditions.	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.