OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device

Starting soon · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT07507903

Run by

Aktiia SA

People needed

200

Starts

2026-04-20

Expected to finish

2026-12-31

Last updated by the study team

2026-04-17

Who can join

Age: 22 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)
• 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 .
• Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.
• 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.
• 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.
• 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.
• 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.

Where it is running

• Parameters Research Laboratory — Broomfield, Colorado, United States

Full record on ClinicalTrials.gov

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