Hypertension
Conditions
Keywords
blood pressure
Brief summary
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.
Interventions
Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references. Main references: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.
Sponsors
Aktiia SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure mean value of differences | 7 days | The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements. |
| Blood pressure standard deviation of differences | 7 days | The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate root-mean-square error | 7 days | The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method. |
Countries
United States
Contacts
CONTACTAnne Fedor Chief Clinical Research Officer
Outcome results
None listed