Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device at Wrist Against Double Auscultation
- Conditions
- Hypertension
- Registration Number
- NCT06565780
- Lead Sponsor
- Aktiia SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria:<br><br> 1. Participants must be able to provide an informed consent to participate.<br><br> 2. Participant must be willing and able to comply with all of the study procedures and<br> return for a day 2 visit.<br><br> 3. Participants must be 22 to 59 years of age.<br><br> 4. Participant or witness must be able to read or write in English.<br><br>Exclusion Criteria:<br><br> 1. Participants with compromised circulation, injury, or physical malformation of the<br> equipment test sites or other sensor sites which would limit the ability to test<br> sites needed for the study. (Note: Certain malformations may still allow<br> participants to participate if the condition is noted and would not affect the sites<br> utilized.)<br><br> 2. Female participants who are known to be pregnant or who are trying to get pregnant<br> confirmed by a day 1 positive urine pregnancy test unless the study participant is<br> known to be not of child-bearing potential.<br><br> 3. Participants with known clotting disorders or currently taking a prescription blood<br> thinner.<br><br> 4. Other known health conditions that will prevent safe participation in the study upon<br> disclosure in Health Assessment Short Form or verbally.<br><br> 5. Participants suffering from sustained cardiac arrhythmias that can lead to weak or<br> unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and<br> atrial fibrillation.<br><br> 6. Participants suffering from pathologies that systematically reduce peripheral<br> perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL /<br> min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.<br><br> 7. A wrist circumference below 14 cm or above 21 cm.<br><br> 8. An upper arm circumference < 22cm or > 42cm.<br><br> 9. Any subject that, in the opinion of the investigator, does not exhibit any phenotype<br> relevant to the objectives of this study.<br><br> 10. Any condition or circumstance that, in the opinion of the investigator, may preclude<br> study completion, interfere with accurate data collection, bias the results.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure mean value of differences;Blood pressure standard deviation of differences
- Secondary Outcome Measures
Name Time Method Heart rate root-mean-square error