Testing a wrist device that measures blood pressure with light
Checks how accurately a wrist device measures blood pressure and pulse in adults.
Plain-language title generated from the registry record
Registry title: OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
Key facts
- Where
- Broomfield, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 59 years old?
Source: NCT07507903, who can take part
Where in United States
- Parameters Research LaboratoryBroomfield, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aktiia SA
- Trial code
- NCT07507903
- Record updated
- 14 September 2026
- Original description
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.Read full original descriptionShow less
OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.
Inclusion: Participants must be able to provide informed consent to participate; Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later; Participants must be 22 to 59 years of age; Participants or witnesses must be able to read or write in English.
Exclusion: Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner; 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.); Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally; 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; 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; 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; 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 ; A wrist circumference below 14 cm or above 23 cm; An upper-arm circumference <22 cm or > 42cm; Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.