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Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk

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.

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ClinicalTrials.gov IDNCT06670677

PhaseNot Applicable

Enrollment15000

SponsorAktiia SA

Age21 Years – 85 Years

SexALL

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Conditions studied

Hypertension, Cardiovascular Risk, Blood Pressure Check (Hypertension Screening)

About this study

Interventions

Other: Lifestyle survey completion — For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
Other: Unlimited on-demand blood pressure measurements with G2C — For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated
Other: Continual blood pressure measurements with G1 — For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.

Primary outcomes

Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors (10 years)

Eligibility information

Inclusion Criteria: 1. Adult subjects aged 21 to 85 years old 2. Subjects living in Switzerland, Germany or in the UK 3. 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) 4. Subjects agreeing to follow the study procedures. Exclusion Criteria: 1. 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; 2. 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; 3. Subjects suffering from polyneuropathy; 4. on pregnant women; 5. Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements) 6. Subjects with amputated index fingers (for camera measurements) or amputated upper limb; 7. Subjects below 21 years old and above 85 years old.

Study locations

Fully remote study- no physical investigational site, Lausanne, Switzerland
Fully remote study- no physical investigational site, London, United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.