Clinical trial NCT05401435: Reliability of Measuring Blood Pressure With a Smartwatch
Official title: Reliability of Measuring Blood Pressure With a Smartwatch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Heart Rate
Keywords: blood pressure measurement
heart rate measurement
smartwatch
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any acute illness
* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* diabetes
* hypotension or hypertension

Primary outcomes:
measure: Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations
timeFrame: 28 days
measure: Change in long-term similarity of heart rate measurements from two devices
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Faculty of Biomedical Engineering, Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University in Prague
name: Barbora Nezpevakova, Bc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Veronika Rafl Huttova, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Martin Rozanek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Jakub Rafl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.