Parameters Research Laboratory
Broomfield, Colorado, 80021, United States
NCT Number: NCT06565780
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
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Notify Me22 year–59 year
All sexes
Interventional
Not applicable
Broomfield, Colorado, 80021, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.
Device under Test: Aktiia.product-G0 References: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.
Time frame: 23 hours
The mean value of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
Time frame: 23 hours
The standard deviation of the differences between Aktiia.product-G0 and double auscultation blood pressure measurements.
Time frame: 23 hours
The root-mean-square difference between the Aktiia.product-G0 heart rate determinations and the reference method.
Aktiia SA
Industry
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device At Wrist Against Double Auscultation: a Multicentric Prospective Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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