Evidence map›Paper›PMID 31365190›Full record

ArticleClinical and translational science2019

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

Elena S Izmailova, Ian L McLean, Greg Hather, David Merberg, Jason Homsy, Matthew Cantor, Dmitri Volfson, Gaurav Bhatia, Eric D Perakslis, Christopher Benko and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

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  13. Objective Behavioral Measures in Children before, during, and after the COVID-19 Lockdown in Israel.International journal of environmental research and public health · 2021
    Article
  14. Article
  15. [Research progress on wearable physiological parameter monitoring and its clinical applications].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2021
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Elena S IzmailovaTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
Ian L McLeanTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
Greg HatherTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
David MerbergTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-5153-2889
Jason HomsyTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
Matthew CantorKoneksa Health Inc., New York, New York, USA.
Dmitri VolfsonTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
Gaurav BhatiaKoneksa Health Inc., New York, New York, USA.
Eric D PerakslisTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.
Christopher BenkoKoneksa Health Inc., New York, New York, USA.ORCID 0000-0001-5120-1767
John A WagnerTakeda Pharmaceuticals International, Inc., Cambridge, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Wearable Electronic DevicesActigraphyAdultAmphetamineElectrocardiography, AmbulatoryExerciseFeasibility StudiesHeart RateHumansMaleMiddle AgedRespiratory RateAmphetamine

Identifiers

PMID31365190
PMCPMC6853263

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.