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The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.
Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure and heart rate measurement | Experimental | Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resting measurement of blood pressure and heart rate | Other | Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations | The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days. | 28 days |
| Change in long-term similarity of heart rate measurements from two devices | The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbora Nezpevakova, Bc. | Contact | +420728096216 | nezpebar@fbmi.cvut.cz | |
| Veronika Rafl Huttova, MSc | Contact | +420224355049 | huttover@fbmi.cvut.cz |
| Name | Affiliation | Role |
|---|---|---|
| Barbora Nezpevakova, Bc. | Czech Technical University in Prague | Principal Investigator |
| Veronika Rafl Huttova, MSc | Czech Technical University in Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Biomedical Engineering, Czech Technical University in Prague | Recruiting | Kladno | 27201 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31423912 | Background | van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26. |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Two measuring devices are active simultaneously during single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.
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| Martin Rozanek, PhD |
| Czech Technical University in Prague |
| Principal Investigator |
| Jakub Rafl, PhD | Czech Technical University in Prague | Principal Investigator |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |