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| Name | Class |
|---|---|
| Pharmaxi LLC | INDUSTRY |
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The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).
Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm for HRV monitoring | Other | For monitoring HRV each subject will put Wristband for registration of ECG RR intervals for one hand, SenceBand in the left wrist and Holter monitor electrodes will be placed in standard configurations places. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenceBand | Device | Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| RR interval accuracy | Accuracy of RR intervals estimating | 5-minute intervals every 30 minutes within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| RR-intervals passing | Frequency of passing of determination of RR-intervals | 5-minute intervals every 30 minutes within 24 hours of use |
| HRV accuracy for time-domain measures | HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yulia Kuznetsova-Arabuli, MD | Dr. Sam LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doctor Sam Medical Network | Kyiv | Kyiv Oblast | Ukraine |
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| 5-minute intervals every 30 minutes within 24 hours |
| HRV accuracy for frequency-domain measures | HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF) | 5-minute intervals every 30 minutes within 24 hours |
| HRV accuracy for time-domain measures | HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50) | 24 hours intervals |
| HRV accuracy for frequency-domain measures | HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF) | 24 hours intervals |