TY - JOUR
T1 - Clinical validation of a novel wearable system for real-time telemetric transmission of transient changes of cardiac autonomic modulation induced by psychophysiological and physical stress
AU - Brisinda, Donatella
AU - Di Florio, E
AU - Minen, M
AU - Affanni, A
AU - Savorgnan, C
AU - Minen, D
AU - Fenici, Riccardo
PY - 2020
Y1 - 2020
N2 - Background: Although clinical assessment of cardiac autonomic modulation (CAM) usually relies on off-line heart
rate variability analysis (HRVa), measured under stationary conditions according to guidelines, there is a growing
interest, in sports medicine and psychophysiology, for the reliable evaluation of acute changes of CAM occurring
under real-world dynamics (i.e. acute stress induced by competitions or critical situations). The aim of this study was to test, with a standardized clinical protocol inducing enhancement of sympathetic/vagal modulation, the reliability of a novel system for continuous monitoring and telemetric transmission of transient CAM changes (Vi-
BioBox), provided by real-time calculation of time-variant HRV parameters and Skin Potential Response (SPR).
Methods: All measurements were performed in the laboratory for clinical electrophysiology. The Vi-BioBox
system (Vi-grade, Udine) consists of a wearable wireless mini-recording device connected to a textile electrode
garment (Nuubo, Spain) and hands electrodes. 3 ECG and 2 SPR signal are continuously recorded (1 KHz sampling-rate) and streamed in real-time to Wintax4 (Magneti-Marelli) data logging for real-time calculation and
monitoring of spectral HRV parameters and of the Root Mean Square value of two SPR signals (SPRRMS) with a proprietary custom software (Vi-BioSoft). 10 healthy volunteers (mean age 32.4±16.8 y, 50% males) underwent a 5-steps protocol: 1) 10-minutes baseline supine; 2) 10-minutes Head-up tilting 70° (HUTT); 3) 10-minutes supine
recovery); 4) 20-minutes mental stress ("Mensa" preliminary Tests); 5) exercise-test at bicycle-ergometer. 12-
lead ECG was continuously recorded also with Mortara Surveyor/X-Scribe and Time-variant HRV parameters were
also calculated off-line with Kubios (3.0.2) software. Statistical analysis was performed with SPSS 21.
Results: The quality of the Vi-BioBox signals was optimal for reproducible real-time calculation and monitoring of
time-variant HRV parameters. Baseline SPRRMS activity ranged between 0.01 and 0.8 mV, with wide
interindividual variability. A significant (p<0.05) increment (up to 2.6 mV) was induced by HUTT, but not by
physical exercise. SPRRMS and LF/HF had similar trend along test session. Good agreement was found between
HRV parameters calculated in real-time, their off-line recalculation with Kubios software and those obtained from
Mortara telemetry.
Conclusion: Real-time monitoring of time-variant spectral HRV parameters and of SPRRMS was reliable and
reproducible. SPRRMS is an independent sensitive marker of sympathetic activation, which anticipates
increments of VLF, LF and is useful to interpret CAM underlying of LF/HF changes. Real-time monitoring of CAM
may be useful to improve the mechanistic understanding of acute psychophysiological stress-reactions,
dysautonomic syncope, arrhythmic events initiation and for telemedicine (i.e. continuous remote monitoring of CAM in patients with heart failure).
AB - Background: Although clinical assessment of cardiac autonomic modulation (CAM) usually relies on off-line heart
rate variability analysis (HRVa), measured under stationary conditions according to guidelines, there is a growing
interest, in sports medicine and psychophysiology, for the reliable evaluation of acute changes of CAM occurring
under real-world dynamics (i.e. acute stress induced by competitions or critical situations). The aim of this study was to test, with a standardized clinical protocol inducing enhancement of sympathetic/vagal modulation, the reliability of a novel system for continuous monitoring and telemetric transmission of transient CAM changes (Vi-
BioBox), provided by real-time calculation of time-variant HRV parameters and Skin Potential Response (SPR).
Methods: All measurements were performed in the laboratory for clinical electrophysiology. The Vi-BioBox
system (Vi-grade, Udine) consists of a wearable wireless mini-recording device connected to a textile electrode
garment (Nuubo, Spain) and hands electrodes. 3 ECG and 2 SPR signal are continuously recorded (1 KHz sampling-rate) and streamed in real-time to Wintax4 (Magneti-Marelli) data logging for real-time calculation and
monitoring of spectral HRV parameters and of the Root Mean Square value of two SPR signals (SPRRMS) with a proprietary custom software (Vi-BioSoft). 10 healthy volunteers (mean age 32.4±16.8 y, 50% males) underwent a 5-steps protocol: 1) 10-minutes baseline supine; 2) 10-minutes Head-up tilting 70° (HUTT); 3) 10-minutes supine
recovery); 4) 20-minutes mental stress ("Mensa" preliminary Tests); 5) exercise-test at bicycle-ergometer. 12-
lead ECG was continuously recorded also with Mortara Surveyor/X-Scribe and Time-variant HRV parameters were
also calculated off-line with Kubios (3.0.2) software. Statistical analysis was performed with SPSS 21.
Results: The quality of the Vi-BioBox signals was optimal for reproducible real-time calculation and monitoring of
time-variant HRV parameters. Baseline SPRRMS activity ranged between 0.01 and 0.8 mV, with wide
interindividual variability. A significant (p<0.05) increment (up to 2.6 mV) was induced by HUTT, but not by
physical exercise. SPRRMS and LF/HF had similar trend along test session. Good agreement was found between
HRV parameters calculated in real-time, their off-line recalculation with Kubios software and those obtained from
Mortara telemetry.
Conclusion: Real-time monitoring of time-variant spectral HRV parameters and of SPRRMS was reliable and
reproducible. SPRRMS is an independent sensitive marker of sympathetic activation, which anticipates
increments of VLF, LF and is useful to interpret CAM underlying of LF/HF changes. Real-time monitoring of CAM
may be useful to improve the mechanistic understanding of acute psychophysiological stress-reactions,
dysautonomic syncope, arrhythmic events initiation and for telemedicine (i.e. continuous remote monitoring of CAM in patients with heart failure).
KW - Wearable devise for ECG monitoring
KW - Wearable devise for ECG monitoring
UR - http://hdl.handle.net/10807/222784
M3 - Conference article
SN - 0195-668X
VL - 2020
SP - 3476
EP - 3476
JO - European Heart Journal
JF - European Heart Journal
T2 - European Congress of Cardiology
Y2 - 29 August 2020 through 1 September 2020
ER -