Hypertension
Conditions
Brief summary
The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
Interventions
DEVICEInvestigational device Aktiia G2C
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
DEVICEMarketed device used as reference for blood pressure monitoring: double auscultation cuff
Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
DEVICEMarketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
DEVICEMarketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
DEVICEMarketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
DEVICEMarketed device used as reference for pulse rate monitoring: pulse finger oximeter
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Sponsors
Aktiia SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects aged 21 to 85yo * Subjects fluent in written and spoken French * Subjects agreeing to attend the study visit and follow study procedures * Subjects that have signed the informed consent form.
Exclusion criteria
* Amputated index fingers * Damaged/injured skin at index fingers * Damaged/injured skin at wrists * Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation * Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula * Pregnant women * Polyneuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of study subjects that contribute with analyzable raw data collected | 1 hour | Min 85 study subjects contribute with analyzable raw data collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure mean value of differences | 1 hour | The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements. |
| Blood pressure standard deviation of differences | 1 hour | The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements. |
| Pulse rate root-mean-square error | 1 hour | The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method. |
Countries
Switzerland
Contacts
Primary ContactGrégoire Wuerzner, Medical Doctor Prof.
Outcome results
None listed