Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
NCT ID: NCT06573801
Last Updated: 2025-12-01
Study Results
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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COMPLETED
NA
48 participants
INTERVENTIONAL
2025-01-28
2025-11-19
Brief Summary
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The goal of Continuum BP is to evaluate how BP readings from two different types of wrist-worn cuffless devices available on the market (Aktiia and Healthstats BPro Evo) compare with BP taken using an ambulatory BP monitor which records readings over 24h using a standard upper arm cuff. This interventional study will recruit balanced numbers of male and female participants within different age group, who will sequentially wear the Aktiia Bracelet and the Heathstats BPro Evo for a period of 24h, alongside the cuffed ambulatory BP monitor.
If wrist worn devices are found to measure BP reliably, future research will assess if artificial intelligence can use continuous BP readings from these devices to learn patterns and changes in BP; and develop digital twin models to guide better, more precise BP management for individuals.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Aktiia
Participants will wear the Aktiia Bracelet for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed intervals.
Aktiia Bracelet
Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
Spacelabs OnTrak Ambulatory Blood Pressure monitor
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
Healthstats
Participants will wear the Healthstats BPro Evo smart watch for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed interval
Healthstats BPro Evo
Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.
Spacelabs OnTrak Ambulatory Blood Pressure monitor
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
Interventions
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Aktiia Bracelet
Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
Healthstats BPro Evo
Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.
Spacelabs OnTrak Ambulatory Blood Pressure monitor
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.
Eligibility Criteria
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Inclusion Criteria
2. Able to speak and understand English.
3. Able and willing to give informed consent.
4. Independent and mobile.
5. Willing and able to wear devices/no upper limb restrictions.
Exclusion Criteria
2. Vulnerable individuals including those with mental ill-health or who are care dependant.
3. Individuals with serious comorbidities or end organ damage (e.g., previously diagnosed heart failure with New York Heart Association class III/IV, verbal or documented evidence of renal failure or history of dialysis, stroke or myocardial infarction within the last 1-year, previous stroke with residual deficit); and doctor diagnosed hyperthyroidism.
4. Individuals with arterio-venous fistula; or reduced peripheral perfusion identified by a history of Raynaud's syndrome or a pulse pressure of \<30mmHg or a capillary refill time of \>3s in the dominant arm.
5. Individuals with heart rhythm disorders e.g., persistent Atrial Fibrillation and those who have tachycardia \> 120 after 5 minutes of rest.
6. Individuals with skin irritation injury or damage.
7. Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy following enrolment.
8. Life threatening or terminal illness with limited lifespan of \<12months.
9. Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification.
10. Those with very high office BP (greater than Stage 3 hypertension).
11. Interarm difference \>15mmHg in Systolic BP and \>10mmHg in Diastolic BP.
12. Where the PI thinks that it would be technically difficult to obtain or interpret blood pressures measurements.
21 Years
85 Years
ALL
Yes
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Ajay K Gupta
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
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Ajay K Gupta
London, , United Kingdom
Countries
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References
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Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol. 2021 Nov;18(11):785-802. doi: 10.1038/s41569-021-00559-8. Epub 2021 May 28.
Hypertension in adults: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2023 Nov 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK547161/
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.
de la Sierra A, Gorostidi M, Banegas JR, Segura J, de la Cruz JJ, Ruilope LM. Nocturnal hypertension or nondipping: which is better associated with the cardiovascular risk profile? Am J Hypertens. 2014 May;27(5):680-7. doi: 10.1093/ajh/hpt175. Epub 2013 Sep 23.
Townsend RR. Out-of-Office Blood Pressure Monitoring: A Comparison of Ambulatory Blood Pressure Monitoring and Home (Self) Monitoring Of Blood Pressure. Hypertension. 2020 Dec;76(6):1667-1673. doi: 10.1161/HYPERTENSIONAHA.120.14650. Epub 2020 Oct 5. No abstract available.
Stergiou GS, Mukkamala R, Avolio A, Kyriakoulis KG, Mieke S, Murray A, Parati G, Schutte AE, Sharman JE, Asmar R, McManus RJ, Asayama K, De La Sierra A, Head G, Kario K, Kollias A, Myers M, Niiranen T, Ohkubo T, Wang J, Wuerzner G, O'Brien E, Kreutz R, Palatini P; European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2022 Aug 1;40(8):1449-1460. doi: 10.1097/HJH.0000000000003224. Epub 2022 Jun 16.
Stevens SL, Wood S, Koshiaris C, Law K, Glasziou P, Stevens RJ, McManus RJ. Blood pressure variability and cardiovascular disease: systematic review and meta-analysis. BMJ. 2016 Aug 9;354:i4098. doi: 10.1136/bmj.i4098.
Sola J, Cortes M, Perruchoud D, De Marco B, Lobo MD, Pellaton C, Wuerzner G, Fisher NDL, Shah J. Guidance for the Interpretation of Continual Cuffless Blood Pressure Data for the Diagnosis and Management of Hypertension. Front Med Technol. 2022 May 17;4:899143. doi: 10.3389/fmedt.2022.899143. eCollection 2022.
Islam SMS, Chow CK, Daryabeygikhotbehsara R, Subedi N, Rawstorn J, Tegegne T, Karmakar C, Siddiqui MU, Lambert G, Maddison R. Wearable cuffless blood pressure monitoring devices: a systematic review and meta-analysis. Eur Heart J Digit Health. 2022 May 2;3(2):323-337. doi: 10.1093/ehjdh/ztac021. eCollection 2022 Jun.
Tan I, Gnanenthiran SR, Chan J, Kyriakoulis KG, Schlaich MP, Rodgers A, Stergiou GS, Schutte AE. Evaluation of the ability of a commercially available cuffless wearable device to track blood pressure changes. J Hypertens. 2023 Jun 1;41(6):1003-1010. doi: 10.1097/HJH.0000000000003428. Epub 2023 Apr 3.
Hu JR, Martin G, Iyengar S, Kovell LC, Plante TB, Helmond NV, Dart RA, Brady TM, Turkson-Ocran RN, Juraschek SP. Validating cuffless continuous blood pressure monitoring devices. Cardiovasc Digit Health J. 2023 Jan 16;4(1):9-20. doi: 10.1016/j.cvdhj.2023.01.001. eCollection 2023 Feb.
Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
Beaney T, Schutte AE, Stergiou GS, Borghi C, Burger D, Charchar F, Cro S, Diaz A, Damasceno A, Espeche W, Jose AP, Khan N, Kokubo Y, Maheshwari A, Marin MJ, More A, Neupane D, Nilsson P, Patil M, Prabhakaran D, Ramirez A, Rodriguez P, Schlaich M, Steckelings UM, Tomaszewski M, Unger T, Wainford R, Wang J, Williams B, Poulter NR; MMM Investigators*. May Measurement Month 2019: The Global Blood Pressure Screening Campaign of the International Society of Hypertension. Hypertension. 2020 Aug;76(2):333-341. doi: 10.1161/HYPERTENSIONAHA.120.14874. Epub 2020 May 18.
Sola J, Vybornova A, Fallet S, Polychronopoulou E, Wurzner-Ghajarzadeh A, Wuerzner G. Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. Sci Rep. 2021 Oct 19;11(1):20644. doi: 10.1038/s41598-021-99294-w.
Komori T, Eguchi K, Hoshide S, Williams B, Kario K. Comparison of wrist-type and arm-type 24-h blood pressure monitoring devices for ambulatory use. Blood Press Monit. 2013 Feb;18(1):57-62. doi: 10.1097/MBP.0b013e32835d124f.
International Organization for Standardization, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. 2013.
Other Identifiers
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341847
Identifier Type: -
Identifier Source: org_study_id
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