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Status unknownNCT05401435Updated Jun 2, 2022

Reliability of Measuring Blood Pressure With a Smartwatch

An interventional study of Resting measurement of blood pressure and heart rate in Blood Pressure and Heart Rate, sponsored by Czech Technical University in Prague. Status unknown at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Czech Technical University in Prague · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blood Pressure
  • Heart Rate

Keywords

  • blood pressure measurement
  • heart rate measurement
  • smartwatch
03

In context

Lead sponsor

Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • any acute illness
  • pregnancy
  • severe cardiovascular conditions
  • severe asthma or other severe respiratory conditions
  • diabetes
  • hypotension or hypertension
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Blood pressure and heart rate measurement

    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.

    Other: Resting measurement of blood pressure and heart rate

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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days

  2. 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.

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • Faculty of Biomedical Engineering, Czech Technical University in Prague
    Kladno, 27201, Czechia
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31423912 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05401435
Lead sponsor
Czech Technical University in Prague
Responsible party
Sponsor
First posted
Jun 2, 2022
Start date
May 4, 2022
Primary completion
Sep 30, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Jun 2, 2022

Study contacts

Barbora Nezpevakova, Bc.
Contact
nezpebar@fbmi.cvut.cz
+420728096216
Veronika Rafl Huttova, MSc
Contact
huttover@fbmi.cvut.cz
+420224355049
Barbora Nezpevakova, Bc.
principal investigator · Czech Technical University in Prague
Veronika Rafl Huttova, MSc
principal investigator · Czech Technical University in Prague
Martin Rozanek, PhD
principal investigator · Czech Technical University in Prague
Jakub Rafl, PhD
principal investigator · Czech Technical University in Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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