AzTrials
AzTrials

Blood PressureSmartBPNCT06627920

Validation of a Smartwatch for Blood Pressure Monitoring

An observational study of Blood Pressure and Heart Rate, run by European University Miguel de Cervantes at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Accurate measurement of blood pressure is essential for the assessment of cardiovascular health and the prevention of cardiovascular disease. Smartwatches have emerged as a promising option for continuous monitoring of blood pressure outside the clinical setting. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Blood Pressure, Heart Rate, Oxygen Saturation
What is being tested?
Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.
Type of treatment
Medical device
How many people
101 participants
Where
1 siteSpain
Study dates
10 Jul 2024to 21 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Observational cross-sectional study with participants at least 18 years of age. Participants will be recruited from the European University Miguel de Cervantes. Once the protocol has been explained and the informed consent has been signed, measurements will be taken.

Who may be able to join

  • Be ≥18 years old and able to understand the informed consent.

Who cannot join

  • A difference of ≥20 mmHg in systolic and/or diastolic blood pressure between both arms.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • European University Miguel de Cervantes

    Valladolid, Castille and León, 47012

Other trials in Spain

About this study

Official title: Validation of a Smartwatch for Blood Pressure Measurement

Accurate measurement of blood pressure is essential for the assessment of cardiovascular health and the prevention of cardiovascular disease. Smartwatches have emerged as a promising option for continuous monitoring of blood pressure outside the clinical setting. This study aims to validate the use of the smartwatch KC08 for blood pressure measurement, which is a cost-effective and convenient alternative for blood pressure measurement. A cross-sectional study will be conducted with participants aged greater than or equal to18 years. The measurements of blood pressure, heart rate and oxygen saturation will be performed with the smartwatch KC08, the Beurer PO30 pulse oximeter and the Omron M7 BP monitor. The statistical analysis will evaluate the reliability of the devices and compare the measurements of the two devices using different statistical methods.

Being tested
Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.
Keywords
cardiovascular health, wearable devices, blood pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.Device

    Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor to estimate blood pressure, heart rate and oxygen saturation.

Study groups in NCT06627920
Study groupRoleWhat they receive
DescriptiveA single population is used to estimate blood pressure, heart rate and oxygen saturation in order to study and validate the use of the KC08 smartwatch.
Receives: Device: Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diastolic and systolic blood pressure

    For BP measurement, an Omron M7 automatic blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan) and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. The participant should sit in a comfortable chair with lumbar support for at least 5 minutes prior to the measurement. The participant will be asked to place both feet flat on the floor, without crossing the legs, and rest the arm with the cuff on a table at chest level, palm up. Ensuring that the cuff is properly adjusted but not too tight and in contact with bare skin, the blood pressure will be measured. During this process, the subject should refrain from talking to ensure an accurate and reliable reading. The values obtained will be recorded according to standard blood pressure measurement procedures. 10 measurements separated by 1 minute will be taken with each device. The BP results will be recorded in mmHg.

    Measured: 5 minutes rest; 5 minutes safety BP measurements of both arms; 30 minutes BP measurements (10 measurements in total)

  2. Heart rate

    An Omron M7 automatic blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan), a Beuer PO30 pulse oximeter and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. Heart rate will be recorded while blood pressure measurements are being recorded.

    10 measurements separated by 1 minute will be taken with each device. The heart rate results will be recorded in beats per minute (bpm).

    Measured: 30 minutes (10 measurements in total)

  3. Peripheral oxygen saturation

    A Beurer PO30 pulse oximeter (Beurer GmbH, Mittelstand, Germany) and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. 10 measurements separated by 1 minute will be taken with each device. The peripheral oxygen saturation results will be recorded in percentage of hemoglobin saturation.

    Measured: 30 minutes (10 measurements in total)

  4. Physical activity levels

    Participants' physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ). This questionnaire consists of 7 questions that will help us stratify physical activity levels.

    It is used as a descriptive measure of the users and a possible confounding factor. It takes approximately 2 minutes to complete the questionnaire and we do it in the initial interview, before starting with the measurements of BP, heart rate and peripheral oxygen saturation.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start10 Jul 2024
  3. Primary completion21 Nov 2024
  4. Study completion21 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627920
Sponsor's protocol ID
PI-DOC007_SmartBP
Acronym
SmartBP
Status last verified
Feb 2025
First submitted
3 Oct 2024
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jose AP, Awasthi A, Kondal D, Kapoor M, Roy A, Prabhakaran D. Impact of repeated blood pressure measurement on blood pressure categorization in a population-based study from India. J Hum Hypertens. 2019 Aug;33(8):594-601. doi: 10.1038/s41371-019-0200-4. Epub 2019 Apr 12.

    PubMed 30979950

  • Boateng EB, Ampofo AG. A glimpse into the future: modelling global prevalence of hypertension. BMC Public Health. 2023 Oct 3;23(1):1906. doi: 10.1186/s12889-023-16662-z.

    PubMed 37789258

  • Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

    PubMed 30165516

  • Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.

    PubMed 29133356

  • Konstantinidis D, Iliakis P, Tatakis F, Thomopoulos K, Dimitriadis K, Tousoulis D, Tsioufis K. Wearable blood pressure measurement devices and new approaches in hypertension management: the digital era. J Hum Hypertens. 2022 Nov;36(11):945-951. doi: 10.1038/s41371-022-00675-z. Epub 2022 Mar 23.

    PubMed 35322181

  • Bradley CK, Shimbo D, Colburn DA, Pugliese DN, Padwal R, Sia SK, Anstey DE. Cuffless Blood Pressure Devices. Am J Hypertens. 2022 May 10;35(5):380-387. doi: 10.1093/ajh/hpac017.

    PubMed 35136906

  • Yi L, Lv ZH, Hu SY, Liu YQ, Yan JB, Zhang H, Li HB, Chen Q, Li YY, Jiang YF, Zhou H, Li MD, Chen RD, Li XL, Zhou SS, Chen YD. Validating the accuracy of a multifunctional smartwatch sphygmomanometer to monitor blood pressure. J Geriatr Cardiol. 2022 Nov 28;19(11):843-852. doi: 10.11909/j.issn.1671-5411.2022.11.004.

    PubMed 36561062

  • Moon JH, Kang MK, Choi CE, Min J, Lee HY, Lim S. Validation of a wearable cuff-less wristwatch-type blood pressure monitoring device. Sci Rep. 2020 Nov 4;10(1):19015. doi: 10.1038/s41598-020-75892-y.

    PubMed 33149118

  • Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, Myers MG, Ogedegbe G, Schwartz JE, Townsend RR, Urbina EM, Viera AJ, White WB, Wright JT Jr. Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. Hypertension. 2019 May;73(5):e35-e66. doi: 10.1161/HYP.0000000000000087.

    PubMed 30827125

  • Atkinson G, Davison RC, Nevill AM. Performance characteristics of gas analysis systems: what we know and what we need to know. Int J Sports Med. 2005 Feb;26 Suppl 1:S2-10. doi: 10.1055/s-2004-830505.

    PubMed 15702453

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Pressure and Heart Rate, run by European University Miguel de Cervantes at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diastolic and systolic blood pressure (time frame: 5 minutes rest; 5 minutes safety BP measurements of both arms; 30 minutes BP measurements (10 measurements in total)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627920, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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