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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 100 participants will be enrolled. This is a decentralized study across the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Scooter Plowman, MD | Verily Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verily Life Sciences | South San Francisco | California | 94080 | United States |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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