Validation of a Smartwatch for Blood Pressure Monitoring

NCT ID: NCT06627920

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-10

Study Completion Date

2024-11-21

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure Heart Rate Oxygen Saturation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Descriptive

A 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.

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* A difference of ≥20 mmHg in systolic and/or diastolic blood pressure between both arms.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Valladolid University Clinical Hospital. Cardiology Department.

UNKNOWN

Sponsor Role collaborator

European University Miguel de Cervantes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European University Miguel de Cervantes

Valladolid, Castille and León, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 30979950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37789258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30165516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29133356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35322181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35136906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36561062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33149118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30827125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15702453 (View on PubMed)

Other Identifiers

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PI-DOC007_SmartBP

Identifier Type: -

Identifier Source: org_study_id

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