Dataset Information

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

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 below, within, and above the normal range were consistent with BodyGuardian measurements. The BodyGuardian device detected clear HR responses after amphetamine administration while subjects were physically active, whereas conventional measures collected at predefined timepoints while subjects were resting and supine did not. Wearable digital technology shows promise for monitoring human subjects for physiologic changes and pharmacologic responses, although fit-for-purpose evaluation and validation continues to be important prior to the wider deployment of these devices.

SUBMITTER: Izmailova ES

PROVIDER: S-EPMC6853263 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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

Izmailova Elena S ES McLean Ian L IL Hather Greg G Merberg David D Homsy Jason J Cantor Matthew M Volfson Dmitri D Bhatia Gaurav G Perakslis Eric D ED Benko Christopher C Wagner John A JA

Clinical and translational science 20190927 6

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 Ph ...[more]

PMID: 31365190

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Project description:BACKGROUND:The proliferation of wearable devices that collect activity and heart rate data has facilitated new ways to measure sleeping and waking durations unobtrusively and longitudinally. Most existing sleep/wake identification algorithms are based on activity only and are trained on expensive and laboriously annotated polysomnography (PSG). Heart rate can also be reflective of sleep/wake transitions, which has motivated its investigation herein in an unsupervised algorithm. Moreover, it is necessary to develop a personalized approach to deal with interindividual variance in sleep/wake patterns. OBJECTIVE:We aimed to develop an unsupervised personalized sleep/wake identification algorithm using multifaceted data to explore the benefits of incorporating both heart rate and activity level in these types of algorithms and to compare this approach's output with that of an existing commercial wearable device's algorithms. METHODS:In this study, a total of 14 community-dwelling older adults wore wearable devices (Fitbit Alta; Fitbit Inc) 24 hours a day and 7 days a week over period of 3 months during which their heart rate and activity data were collected. After preprocessing the data, a model was developed to distinguish sleep/wake states based on each individual's data. We proposed the use of hidden Markov models and compared different modeling schemes. With the best model selected, sleep/wake patterns were characterized by estimated parameters in hidden Markov models, and sleep/wake states were identified. RESULTS:When applying our proposed algorithm on a daily basis, we found there were significant differences in estimated parameters between weekday models and weekend models for some participants. CONCLUSIONS:Our unsupervised approach can be effectively implemented based on an individual's multifaceted sleep-related data from a commercial wearable device. A personalized model is shown to be necessary given the interindividual variability in estimated parameters.

Project description:BackgroundVariations in body temperature are highly informative during an illness. To date, there are not many adequate studies that have investigated the feasibility of a wearable wrist device for the continuous monitoring of body surface temperatures in humans.ObjectiveThe objective of this study was to validate the performance of HEARThermo, an innovative wearable device, which was developed to continuously monitor the body surface temperature in humans.MethodsWe implemented a multi-method research design in this study, which included 2 validation studies-one in the laboratory and one with human subjects. In validation study I, we evaluated the test-retest reliability of HEARThermo in the laboratory to measure the temperature and to correct the values recorded by each HEARThermo by using linear regression models. We conducted validation study II on human subjects who wore HEARThermo for the measurement of their body surface temperatures. Additionally, we compared the HEARThermo temperature recordings with those recorded by the infrared skin thermometer simultaneously. We used intraclass correlation coefficients (ICCs) and Bland-Altman plots to analyze the criterion validity and agreement between the 2 measurement tools.ResultsA total of 66 participants (age range, 10-77 years) were recruited, and 152,881 completed data were analyzed in this study. The 2 validation studies in the laboratory and on human skin indicated that HEARThermo showed a good test-retest reliability (ICC 0.96-0.98) and adequate criterion validity with the infrared skin thermometer at room temperatures of 20°C-27.9°C (ICC 0.72, P<.001). The corrected measurement bias averaged -0.02°C, which was calibrated using a water bath ranging in temperature from 16°C to 40°C. The values of each HEARThermo improved by the regression models were not significantly different from the temperature of the water bath (P=.19). Bland-Altman plots showed no visualized systematic bias. HEARThermo had a bias of 1.51°C with a 95% limit of agreement between -1.34°C and 4.35°C.ConclusionsThe findings of our study show the validation of HEARThermo for the continuous monitoring of body surface temperatures in humans.

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

Publications

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

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