Rationale: <TBD>
Reference: Weippert, M., Kumar, M., Kreuzfeld, S., Arndt, D., Rieger, A. and Stoll, R. (2010). Comparison of three mobile devices for measuring R–R intervals and heart rate variability: Polar S810i, Suunto t6 and an ambulatory ECG system. European Journal of Applied Physiology, 109(4), pp.779-786. Caminal, P., Sola, F., Gomis, P., Guasch, E., Perera, A., Soriano, N. and Mont, L. (2018). Validity of the Polar V800 monitor for measuring heart rate variability in mountain running route conditions. European Journal of Applied Physiology, 118(3), pp.669-677. Gamelin, F., Berthoin, S. and Bosquet, L. (2006). Validity of the Polar S810 Heart Rate Monitor to Measure R-R Intervals at Rest. Medicine & Science in Sports & Exercise, 38(5), pp.887-893. |
Diagnosis and criteria for inclusion/exclusion:
Inclusion criteria Subject has given written informed consent; Subject is male or female, aged 18-75; Subject has understood and complied with the requirements of the study protocol; Subject is judged suitable for the study by Investigator.
Exclusion Criteria - Subject has cardiac pacemakers;
- Subject has taken any medication or substances that might affect HRV;
- Subject has clinically significant cardiac arrhythmia;
- Subject has tattoos around the wrist or forearm area;
- Female is pregnant;
|
Criteria for evaluation:
Primary outcomes measures: RR interval accuracy for heart-rate monitor compared to XXXXXXX monitor expressed as correlation coefficient;
Data will be provided by the correlation coefficient and will also be depicted by Bland-Altman plots.
Secondary outcomes measures: RR interval errors rate (overall and for each type); HRV accuracy for time-domain parameters (MeanNN, SDNN, RMSSD, pNN50) HRV accuracy for frequency-domain parameters (VLF, LF, HF, LF/HF …);;
Safety outcomes measures: Adverse events/Serious Adverse Events
|
