Blood Pressure, Heart Rate
Conditions
Keywords
blood pressure measurement, heart rate measurement, smartwatch
Brief summary
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.
Detailed description
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.
Interventions
OTHERResting measurement of blood pressure and heart rate
Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).
Sponsors
Czech Technical University in Prague
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers
Exclusion criteria
* any acute illness * pregnancy * severe cardiovascular conditions * severe asthma or other severe respiratory conditions * diabetes * hypotension or hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations | 28 days | 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. |
| Change in long-term similarity of heart rate measurements from two devices | 28 days | 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. |
Countries
Czechia
Contacts
Primary ContactBarbora Nezpevakova, Bc.
Backup ContactVeronika Rafl Huttova, MSc
Outcome results
None listed