CClinicalTrials.gg
CompletedNCT06573801Continuum BPUpdated Dec 1, 2025

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

An interventional study of Aktiia Bracelet and Healthstats BPro Evo in Blood Pressure, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Queen Mary University of London · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
21 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Pressure
03

In context

Lead sponsor

Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Participant is aged ≥21 years and \<85 years at the time of screening visit.
  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

Exclusion Criteria:

  1. Individuals who are or have been involved in interventional research within a period of 3 months.
  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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    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.

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

  • Active comparator
    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

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

Interventions

  • DeviceAktiia Bracelet

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

  • DeviceHealthstats BPro Evo

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

  • DeviceSpacelabs OnTrak Ambulatory Blood Pressure monitor

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

06

What researchers measure

Primary outcomes

  1. Mean Daytime BP Difference

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

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

Secondary outcomes

  1. Mean 24 hours BP Difference

    Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over 24 hours.

    Time frame: Up to 24 hours from device application.

  2. Mean Nighttime BP Difference

    Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over night-time.

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

  3. Difference in Blood Pressure Variability

    Difference in BP variability during daytime and night-time BP recorded by ambulatory BP monitor and each device.

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

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

    Measure(s) of acceptability of wearing cuffless BP monitors (compared with wearing ambulatory BP monitor) will include comfort, ability to carry on daily activities, interference with sleep and willingness to use device for long term. These will be reported using descriptive methods for each device, likely as proportions according to the following response options: strongly disagree, disagree, neither agree nor disagree, agree and strongly agree.

    Time frame: Up to 24 hours from device application

07

Study locations

1 site
  • Ajay K Gupta
    London, EC1M 6BQ, United Kingdom
08

References and documents

Publications

  • 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. PubMed 34050340 ↗
  • Hypertension in adults: diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2026 Feb 26. Available from http://www.ncbi.nlm.nih.gov/books/NBK547161/ PubMed 31577399 ↗
  • 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 ↗
  • 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. PubMed 24061070 ↗
  • 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. PubMed 33012202 ↗
  • 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. PubMed 35708294 ↗
  • 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. PubMed 27511067 ↗
  • 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. PubMed 35655524 ↗
  • 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. PubMed 36713001 ↗
  • 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. PubMed 37016925 ↗
  • 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. PubMed 36865583 ↗
  • 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. PubMed 24002282 ↗
  • 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. PubMed 32419505 ↗
  • 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. PubMed 34667230 ↗
  • 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. PubMed 23263536 ↗
  • International Organization for Standardization, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. 2013.
  • Gupta AK, Ahmed A, Bowles R, Learoyd A, Kirkpatrick E, Gurung N, Rathod K, Ahluwalia A, Mathur A; Continuum BP Investigators. A randomized crossover clinical trial comparing 24-h blood pressure measurements from two different cuffless wrist ambulatory monitors with cuffed ambulatory monitoring for translation to clinical practice: Rationale and Design of Continuum BP study. Am Heart J Plus. 2026 Apr 6;65:100778. doi: 10.1016/j.ahjo.2026.100778. eCollection 2026 May. PubMed 42007007 ↗

Individual participant data

Plan to share: No — Anonymized data may be provided after publication of findings on reasonable request as per unit's policy.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06573801
Lead sponsor
Queen Mary University of London
Responsible party
Sponsor
First posted
Aug 27, 2024
Start date
Jan 28, 2025
Primary completion
Nov 19, 2025
Completion
Nov 19, 2025
Last update
Dec 1, 2025

Study contacts

Ajay K Gupta
principal investigator · Queen Mary University of London

Oversight

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

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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