Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
Recruiting · NCT06670677 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aktiia SA
View the official record on ClinicalTrials.gov →Interventions studied
Continual blood pressure measurements with G1Lifestyle survey completionUnlimited on-demand blood pressure measurements with G2C
What this trial is about
Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.
Who can take part
Age range
21 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adult subjects aged 21 to 85 years old
- Subjects living in Switzerland, Germany or in the UK
- Subjects that are:
- Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3)
- Subjects agreeing to follow the study procedures.
Exclusion criteria
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting 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), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula;
- Subjects suffering from polyneuropathy;
- on pregnant women;
- Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)
- Subjects with amputated index fingers (for camera measurements) or amputated upper limb;
- Subjects below 21 years old and above 85 years old.
Where it is running
2 locations listed.
- Fully remote study- no physical investigational site - Lausanne, Switzerland
- Fully remote study- no physical investigational site - London, United Kingdom