Blood PressureContinuum BPNCT06573801

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

A study testing Aktiia Bracelet, Healthstats BPro Evo and Spacelabs OnTrak Ambulatory Blood Pressure monitor in people with Blood Pressure, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

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

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: Aktiia Bracelet, Healthstats BPro Evo and Spacelabs OnTrak Ambulatory Blood Pressure monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 28 Jan 2025to 19 Nov 2025
Phase: Interventional
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 21 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Ajay K Gupta
London, EC1M 6BQ

Other trials in United Kingdom

About this study

Official title: A Single Centre Randomised Prospective Cross-over Study to Assess Agreement Between Blood Pressure Measurements Taken Using Cuffless Wearable and Cuffed, Ambulatory Blood Pressure Monitoring Devices.

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
Being tested: Aktiia Bracelet, Healthstats BPro Evo, Spacelabs OnTrak Ambulatory Blood Pressure monitor

What participants receive

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

Aktiia BraceletDevice
Wrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.
Healthstats BPro EvoDevice
Wrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.
Spacelabs OnTrak Ambulatory Blood Pressure monitorDevice
Cuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.

Study groups in NCT06573801
Study group	Role	What they receive
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. Receives: 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 Receives: Device: Healthstats BPro Evo; Device: Spacelabs OnTrak Ambulatory Blood Pressure monitor

What is being measured

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

Mean Daytime BP Difference
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over daytime.
Measured: Up to 24 hours from device application, using readings from 7am to 11pm.

Secondary outcomes (4)

Mean 24 hours BP Difference
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over 24 hours.
Measured: Up to 24 hours from device application.
Mean Nighttime BP Difference
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over night-time.
Measured: Up to 24 hours from device application, using readings from 11pm to 7am.
Difference in Blood Pressure Variability
Difference in BP variability during daytime and night-time BP recorded by ambulatory BP monitor and each device.
Measured: 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.
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.
Measured: Up to 24 hours from device application

Timeline

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

28 Jan 202519 Nov 2025

First posted27 Aug 2024
Study start28 Jan 2025
Primary completion19 Nov 2025
Study completion19 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06573801
Sponsor's protocol ID: 341847
Acronym: Continuum BP
Status last verified: Nov 2025
First submitted: 13 Aug 2024
Last updated: 1 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Anonymized data may be provided after publication of findings on reasonable request as per unit's policy.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Centre Randomised Prospective Cross-over Study to Assess Agreement Between Blood Pressure Measurements Taken Using Cuffless Wearable and Cuffed, Ambulatory Blood Pressure Monitoring Devices.
ClinicalTrials.gov ID: NCT06573801
Acronym / sponsor ID: Continuum BP / 341847
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Queen Mary University of LondonUniversity, hospital or other
Study start: 28 Jan 2025 (actual)
Primary completion: 19 Nov 2025 (actual)
Study completion: 19 Nov 2025 (actual)
First posted: 27 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aktiia	Active comparator	Device: Aktiia Bracelet, Device: Spacelabs OnTrak Ambulatory Blood Pressure monitorParticipants will wear the Aktiia Bracelet for 24h alongside a cuffed ambulatory BP monitor. Both devices will be recording BP at pre programmed intervals.
Healthstats	Active comparator	Device: Healthstats BPro Evo, Device: Spacelabs OnTrak Ambulatory Blood Pressure monitorParticipants 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

Who may qualify

Ages: 21 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aktiia BraceletWrist worn bracelet with an optical sensor that measures pulse wave characteristics at the wrist.	Device	Aktiia
Healthstats BPro EvoWrist worn watch that uses applanation tonometry to measure pulse wave characteristics at the wrist.	Device	Healthstats
Spacelabs OnTrak Ambulatory Blood Pressure monitorCuffed ambulatory BP monitor that will measure upper arm BP using oscillometry.	Device	Aktiia, Healthstats

Primary outcome

Mean Daytime BP Difference
Time frame: Up to 24 hours from device application, using readings from 7am to 11pm.
Difference in average Systolic and Diastolic BP measured using ambulatory BP monitor and each device over daytime.

4 secondary outcomes

Mean 24 hours BP Difference
Time frame: Up to 24 hours from device application.
Mean Nighttime BP Difference
Time frame: Up to 24 hours from device application, using readings from 11pm to 7am.
Difference in Blood Pressure Variability
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.
Acceptability of wearing cuffless BP devices using a (simple non-validated) Likert-type device wearability questionnaire.
Time frame: Up to 24 hours from device application

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
Background: PubMed 34050340Zhou 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.
Background: PubMed 31577399Hypertension 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/
Background: PubMed 30827125Muntner 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.
Background: PubMed 24061070de 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.
Background: PubMed 33012202Townsend 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.
Background: PubMed 35708294Stergiou 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.
Background: PubMed 27511067Stevens 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.
Background: PubMed 35655524Sola 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.
Background: PubMed 36713001Islam 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.
Background: PubMed 37016925Tan 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.
Background: PubMed 36865583Hu 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.
Background: PubMed 24002282Chow 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.
Individual participant dataSharing planned: No. Anonymized data may be provided after publication of findings on reasonable request as per unit's policy.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ajay K Gupta principal investigator

Queen Mary University of London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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 1 Dec 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 United Kingdom. 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?

Mean Daytime BP Difference (time frame: Up to 24 hours from device application, using readings from 7am to 11pm.). 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 NCT06573801, which also lists 17 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 1 Dec 2025.