Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan 21;9(1):17.
doi: 10.3390/bios9010017.

A Novel Wearable Device for Continuous Ambulatory ECG Recording: Proof of Concept and Assessment of Signal Quality

Christian Steinberg  1 , François Philippon  2 , Marina Sanchez  3 , Pascal Fortier-Poisson  4 , Gilles O'Hara  5 , Franck Molin  6 , Jean-François Sarrazin  7 , Isabelle Nault  8 , Louis Blier  9 , Karine Roy  10 , Benoit Plourde  10 , Jean Champagne  11
Affiliations

A Novel Wearable Device for Continuous Ambulatory ECG Recording: Proof of Concept and Assessment of Signal Quality

Christian Steinberg et al. Biosensors (Basel). .

Abstract

Diagnosis of arrhythmic disorders is challenging because of their short-lasting, intermittent character. Conventional technologies of noninvasive ambulatory rhythm monitoring are limited by modest sensitivity. We present a novel form of wearable electrocardiogram (ECG) sensors providing an alternative tool for long-term rhythm monitoring with the potential of increased sensitivity to detect intermittent or subclinical arrhythmia. The objective was to assess the signal quality and R-R coverage of a wearable ECG sensor system compared to a standard 3-lead Holter. In this phase-1 trial, healthy individuals underwent 24-h simultaneous rhythm monitoring using the OMsignal system together with a 3-lead Holter recording. The OMsignal system consists of a garment (bra or shirt) with integrated sensors recording a single-lead ECG and an acquisition module for data storage and processing. Head-to-head signal quality was assessed regarding adequate P-QRS-T distinction and was performed by three electrophysiologists blinded to the recording technology. The accuracy of signal coverage was assessed using Bland-Altman analysis. Fifteen individuals underwent simultaneous 24-h recording. Signal quality and accuracy of the OMgaments was equivalent to Holter-monitoring (84% vs 93% electrophysiologists rating, p = 0.06). Signal coverage of R-R intervals showed a very close overlay between the OMsignal system and Holter signals, mean difference in heart rate of 2 5 bpm. The noise level of OMgarments was comparable to Holter recording. OMgarments provide high signal quality for adequate rhythm analysis, representing a promising novel technology for long-term non-invasive ECG monitoring.

Keywords: ECG monitoring; Holter; Noninvasive ambulatory rhythm monitoring; telehealth; wearable ECG sensors.

PubMed Disclaimer

Conflict of interest statement

Pascal Fortier-Poisson works as data scientist in the research and development department of OMsignal. However, the manufacturer had no influence on study design, study protocol and data analysis. The manufacturer of the OMgarment did not fund this study. All other authors have no conflict of interests to declare.

Figures

Figure 1
Figure 1
OMgarments are biointeractive wearable ECG sensors. The OMsignal garments represent a novel type of wearable ECG sensors and consist of two different products: The OMshirt (men) (A) and the OMbra (women) (B). Both garments are intended to be worn as underwear and contain integrated, silicone-based sensors that are in contact with the skin recording a single-lead ECG corresponding to a modified V5-lead. The ECG sensors are connected to the acquisition module (C) through five snaps (D). The acquisition module has the capacity to save or process ECG signals for real-time or offline analysis.
Figure 2
Figure 2
ECG samples of simultaneous recording with OMgarments and Holter. Shown are two samples of simultaneous recording with the OMgarment and a standard 3-lead Holter. The precise beat-to-beat signal coverage of the OMgarment allows even detection of subtle rhythm phenomena, such as respiratory sinus arrhythmia. Note the perfect signal overlay between Holter and garment and high signal quality of the ECG tracings from the OMgarments. The displayed ECG tracings from the OMgarment represent unfiltered signals without additional modification to improve signal quality.
Figure 3
Figure 3
Signal coverage of OMgarments and Holter. Shown is the average signal coverage over 24 h for any given R-R interval (A–C) and for any given time point during recording (D–E). Note the almost perfect overlay of signal coverage between OMgarments and Holter recordings.
Figure 4
Figure 4
Bland-Altman analysis for signal coverage. (A) The overall signal coverage by the OMgarment was excellent, showing an almost perfect overlay compared to standard Holter recording with a mean difference in heart rate of only 2 ± 5 bpm. The quality of signal coverage with OMgarments showed no difference between women (B) and men (C) and was equivalent to Holter recording.
Figure 5
Figure 5
Accuracy of signal morphology by semi-quantitative assessment. Shown are histograms of a Kolmogorov distribution derived from the combined score ranking of the averaged semi-quantitative assessment of the overall morphology accuracy of ECG signals recorded by Holter and the OMgarments. Each histogram displays the proportion and degree of diagnostic bins of recordings with the OMgarments compared to Holter regarding the overall accuracy (A) and signal quality of P, QRS, and T (B–D). Diagnostic bins are presented as stacked columns containing the data for males (OMshirt) and females (OMbra). All diagnostic bins below the prespecified noninferiority margin of 15% indicate that the signal quality of the OMgarment was as good as the Holter recording. (A) The overall signal accuracy was noninferior to the Holter recording, but the results were largely driven by recordings in females. Overall signal quality in males was inferior to Holter recording in up to 75% of recordings, mostly related to high levels of noise (please see Section 3.5) and inferior P-wave quality (B). Signal quality of QRS complexes (C) and T-waves (D) were also significantly better in females compared to males.
See this image and copyright information in PMC

References

    1. Tang D.H., Gilligan A.M., Romero K. Economic burden and disparities in healthcare resource use among adult patients with cardiac arrhythmia. Appl. Health Econ. Health Policy. 2014;12:59–71. doi: 10.1007/s40258-013-0070-9. - DOI - PubMed
    1. Steinberg C., Bennett M.T., Krahn A.D. Extended ECG Monitoring. In: Kowey P., Piccini J.P., Naccarelli G., editors. Cardiac Arrhythmias, Pacing and Sudden Death. Springer; Cham, Switzerland: 2017. pp. 48–59.
    1. Survivors of out-of-hospital cardiac arrest with apparently normal heart. Need for definition and standardized clinical evaluation. Consensus Statement of the Joint Steering Committees of the Unexplained Cardiac Arrest Registry of Europe and of the Idiopathic Ventricular Fibrillation Registry of the United States. Circulation. 1997;95:265–272. - PubMed
    1. Tomson T.T., Passman R. Current and Emerging Uses of Insertable Cardiac Monitors: Evaluation of Syncope and Monitoring for Atrial Fibrillation. Cardiol. Rev. 2017;25:22–29. doi: 10.1097/CRD.0000000000000129. - DOI - PubMed
    1. Cheng Y., Ye Y., Hou M., He W., Li Y., Deng X. A Fast and Robust Non-Sparse Signal Recovery Algorithm for Wearable ECG Telemonitoring Using ADMM-Based Block Sparse Bayesian Learning. Sensors. 2018;18:2021. doi: 10.3390/s18072021. - DOI - PMC - PubMed

LinkOut - more resources