Chronic Disease, Healthy Population
Conditions
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.
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.
Sponsors
Verily Life Sciences LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed