Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices

NCT06573801 | Completed

• 1 other identifier: 341847
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Wrist worn devices can help record Blood Pressure (BP) throughout the day. As such devices are becoming increasingly affordable, they could help improve awareness, early diagnosis, and treatment of high and uncontrolled BP. 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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Mean Daytime BP Difference

  Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over daytime.

  Up to 24 hours from device application, using readings from 7am to 11pm.

Secondary Outcomes (4)

• Mean 24 hours BP Difference

  Up to 24 hours from device application.

• Mean Nighttime BP Difference

  Up to 24 hours from device application, using readings from 11pm to 7am.

• Difference in Blood Pressure Variability

  Up to 24 hours from device application, using readings from 7am to 11pm to indicate daytime and 11pm to 7am to indicate night-time.

• Acceptability of wearing cuffless BP devices using a (simple non-validated) Likert-type device wearability questionnaire.

  Up to 24 hours from device application

Study Arms (2)

Aktiia

ACTIVE COMPARATOR

Participants will wear the Aktiia Bracelet for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed intervals.

Device: Aktiia Bracelet; Device: Spacelabs OnTrak Ambulatory Blood Pressure monitor

Healthstats

ACTIVE COMPARATOR

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

Device: Healthstats BPro Evo; Device: Spacelabs OnTrak Ambulatory Blood Pressure monitor

Interventions

Aktiia Bracelet DEVICE

Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.

Aktiia

Healthstats BPro Evo DEVICE

Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.

Healthstats

Spacelabs OnTrak Ambulatory Blood Pressure monitor DEVICE

Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.

Aktiia; Healthstats

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is aged ≥21 years and \<85 years at the time of screening visit.
• Able to speak and understand English.
• Able and willing to give informed consent.
• Independent and mobile.
• Willing and able to wear devices/no upper limb restrictions.

You may not qualify if:

• Individuals who are or have been involved in interventional research within a period of 3 months.
• Vulnerable individuals including those with mental ill-health or who are care dependant.
• 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.
• 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.
• Individuals with heart rhythm disorders e.g., persistent Atrial Fibrillation and those who have tachycardia \> 120 after 5 minutes of rest.
• Individuals with skin irritation injury or damage.
• Self-reported pregnancy. Participation will be withdrawn in the event of pregnancy following enrolment.
• Life threatening or terminal illness with limited lifespan of \<12months.
• Obesity (Body Mass Index 35kg/m2 or higher) or arm/wrist circumferences outside the range highlighted in each device's specification.
• Those with very high office BP (greater than Stage 3 hypertension).
• Interarm difference \>15mmHg in Systolic BP and \>10mmHg in Diastolic BP.
• Where the PI thinks that it would be technically difficult to obtain or interpret blood pressures measurements.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Ajay K Gupta

London, EC1M 6BQ, United Kingdom

Location

Related Publications (16)

• 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.

  PMID: 34050340 BACKGROUND

• 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/

  PMID: 31577399 BACKGROUND

• 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.

  PMID: 30827125 BACKGROUND

• 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.

  PMID: 24061070 BACKGROUND

• 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.

  PMID: 33012202 BACKGROUND

• 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.

  PMID: 35708294 BACKGROUND

• 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.

  PMID: 27511067 BACKGROUND

• 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.

  PMID: 35655524 BACKGROUND

• 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.

  PMID: 36713001 BACKGROUND

• 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.

  PMID: 37016925 BACKGROUND

• 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.

  PMID: 36865583 BACKGROUND

• 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.

  PMID: 24002282 BACKGROUND

• 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.

  PMID: 32419505 BACKGROUND

• 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.

  PMID: 34667230 BACKGROUND

• 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.

  PMID: 23263536 BACKGROUND

• International Organization for Standardization, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. 2013.

  BACKGROUND

Study Officials

• Ajay K Gupta

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 27, 2024
• Study Start: January 28, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)