Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of Amphetamine

Clinical and Translational Science
Elena S IzmailovaJohn A Wagner

Abstract

Wearable digital devices offer potential advantages over traditional methods for the collection of health-related information, including continuous collection of dense data while study subjects are ambulatory or in remote settings. We assessed the utility of collecting continuous actigraphy and cardiac monitoring by deploying two US Food and Drug Administration (FDA) 510(k)-cleared devices in a phase I clinical trial of a novel compound, which included the use of an amphetamine challenge. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep. The Preventice BodyGuardian (BodyGuardian) was used for monitoring heart rate (HR) and respiratory rate (RR), via single-lead electrocardiogram (ECG) recordings, together with physical activity. We measured data collection rates, compared device readouts with conventional measures, and monitored changes in HR measures during the amphetamine challenge. Completeness of data collection was good for the Actiwatch (96%) and lower for the BodyGuardian (80%). A good correlation was observed between device and in-clinic measures for HR (r = 0.99; P < 0.001), but was poor for RR (r = 0.39; P = 0.004). Manual reviews of selected ECG strips corresponding to HR measures...Continue Reading

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Jan 13, 2019·Clinical and Translational Science·Elena S IzmailovaJohn A Wagner
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Citations

May 7, 2020·Expert Opinion on Drug Safety·Susanne B Haga
Mar 28, 2020·Clinical Pharmacology and Therapeutics·Neha MehtaQi Liu
Aug 10, 2020·Clinical and Translational Science·Alan GodfreyElena S Izmailova
Jul 25, 2021·Sensors·Jan Benedikt BrönnekeAriel Dora Stern
Jul 9, 2021·JCO Clinical Cancer Informatics·Elena S Izmailova, William A Wood
Aug 28, 2021·International Journal of Environmental Research and Public Health·Einat ShneorAriela Gordon-Shaag

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Software Mentioned

BodyGuardian
BodyGuardian Connect
R

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