Can your smartwatch replace the blood pressure cuff?
NCT ID NCT06573801
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checked if two wrist-worn cuffless blood pressure devices (Aktiia and Healthstats BPro Evo) give readings that match the standard arm-cuff monitor worn for 24 hours. 48 adults wore each device alongside the standard monitor. The goal is to see if these wearable devices are reliable enough for everyday blood pressure tracking.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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48 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ajay K Gupta
London, EC1M 6BQ, United Kingdom
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Other studies related to the condition(s) this trial covers.
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