One limb. Continuous monitoring.

The essence of the project is comprehensive hardware & software technology for constant HRV monitoring with original wearable ECG R-peaks detector for one hand.

To prove this approach we have gone the path from TRL3 to TRL7.

In order to validate the technology in the lab environment according to IEC 60601-2-25, IEC 60601-2-47, ANSI/AAMI EC57, YY0782 and YY0885 we used WhaleTeq mECG 2.0 generator and data from PhysioNet [1], including European ST-T Database [2], Long-Term ST Database [3], MIT-BIH Malignant Ventricular Arrhythmia Database [4], Creighton University Ventricular Tachyarrhythmia Database [5], Sudden Cardiac Death Holter Database [6] (Fs = 250 Hz; T = 60 sec; N samples = 15000)

All the metrological tests were successfully passed. This allowed to use both short-term and long-term samples for different HRV monitoring scenarios.

After numerous in-house tests in real environment we dared to conduct a complete clinical trial in order to assess SenceBand in real-world condition during 24-hours of routine duties in comparison to a Holter monitor. To assess different ways of monitoring with SenceBand we collected data from 5-minutes intervals each 30 minute within 24 hours in comparison with continuous 24h record of Holter monitor [7].

Comparison of frequency domain indicators of SenceBand vs Holter monitor. SenceBand collected data from 5-minutes intervals each 30 minute within 24 hours and Holter monitor collected data continuously within 24 hours.

The primary outcome of the clinical trial was achieved. No statistically significant difference was found in RR intervals and time domain components in 5-minutes and 24-hours record. No statistically significant difference was found in frequency domain components in 24h records. No clinically significant difference was found in all domain and regimes.

Goldberger, A., Amaral, L., Glass, L., Hausdorff, J., Ivanov, P. C., Mark, R., ... & Stanley, H. E. (2000). PhysioBank, PhysioToolkit, and PhysioNet: Components of a new research resource for complex physiologic signals. Circulation [Online]. 101 (23), pp. e215–e220.
Taddei A, Distante G, Emdin M, Pisani P, Moody GB, Zeelenberg C, Marchesi C. The European ST-T Database: standard for evaluating systems for the analysis of ST-T changes in ambulatory electrocardiography. European Heart Journal 13: 1164-1172 (1992).
Franc Jager, Alessandro Taddei, George B. Moody, Michele Emdin, Gorazd Antolic, Roman Dorn, Ales Smrdel, Carlo Marchesi, and Roger G. Mark. Long-term ST database: a reference for the development and evaluation of automated ischaemia detectors and for the study of the dynamics of myocardial ischaemia. Medical & Biological Engineering & Computing 41(2):172-183 (2003).
Greenwald SD. Development and analysis of a ventricular fibrillation detector. M.S. thesis, MIT Dept. of Electrical Engineering and Computer Science, 1986.
Nolle FM, Badura FK, Catlett JM, Bowser RW, Sketch MH. CREI-GARD, a new concept in computerized arrhythmia monitoring systems. Computers in Cardiology 13:515-518 (1986).
Greenwald SD. Development and analysis of a ventricular fibrillation detector. M.S. thesis, MIT Dept. of Electrical Engineering and Computer Science, 1986.
ClinicalTrials.gov Identifier: NCT0374786

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