No more arm cuffs? new wrist device could change how we check blood pressure
NCT ID NCT07507903
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study is testing a new wrist device that uses light to measure blood pressure without needing a traditional arm cuff. Researchers will compare its readings to standard methods in 200 adults aged 22 to 59 over one week. The goal is to see if the device is accurate and safe enough for everyday use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aktiia optical blood pressure monitoring wrist device
- What this could lead to
- If successful, this could provide a convenient, cuff-free way to monitor blood pressure at home, making it easier for people to track their heart health.
- What could go wrong
- This is an early-stage accuracy study with only 200 participants. The device may not be as precise as standard cuffs, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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22 to 59 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. Participants must be able to provide informed consent to participate. 2. Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later. 3. Participants must be 22 to 59 years of age. 4. Participants or witnesses must be able to read or write in English. Exclusion Criteria: 5. Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.) 6. Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential . 7. Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner. 8. Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally. 9. Participants suffering from sporadic or sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including but not limited to tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation. 10. Participants suffering from sporadic or sustained reduction of peripheral perfusion that can lead to weak or unstable pressure pulses including but not limited to: Raynaud's disease, diabetes (Type I and Type II), renal dysfunctions (eGFR \< 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma, arteriovenous fistula, and valvular heart diseases. 11. A wrist circumference below 14 cm or above 23 cm. 12. An upper-arm circumference \<22 cm or \> 42cm. 13. Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study. 14. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Parameters Research Laboratory
RECRUITINGBroomfield, Colorado, 80021, United States
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