RecruitingNCT06670677

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

OBPM_FORESEE2024: Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk in a Multi-ethnic European Population: an Observational Cohorts' Study


Sponsor

Aktiia SA

Enrollment

15,000 participants

Start Date

May 12, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether the Aktiia wristband — a wearable blood pressure monitor — can detect high blood pressure early and predict cardiovascular risk compared to standard clinical measurements. It is a real-world observational study conducted in Switzerland, Germany, and the UK. **You may be eligible if...** - You are 21–85 years old and live in Switzerland, Germany, or the UK - You own a smartphone (iOS or Android) - You currently use or are willing to try the Aktiia device **You may NOT be eligible if...** - You have irregular heart rhythms (e.g., atrial fibrillation) or resting heart rate above 120 bpm - You have diabetes, severe kidney disease, untreated thyroid conditions, Raynaud's disease, or a condition reducing blood flow to the extremities - You have nerve damage (polyneuropathy) - You are pregnant - You have skin damage, injuries, or amputations at the wrist or finger where measurements are taken Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLifestyle 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.

OTHERUnlimited 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

OTHERContinual 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.


Locations(2)

Fully remote study- no physical investigational site

Lausanne, Switzerland

Fully remote study- no physical investigational site

London, United Kingdom

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NCT06670677


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