NCT06670677

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (estimated)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

ARM 1: N1\~ 3'300 subjects. Research participants are Aktiia G1 users with Android operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with Android operating system. ARM 1 research participants are asked to: * For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * 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. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated. ARM 2: N2\~ 6'600 subjects. Research participants are Aktiia G1 users with iOS operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with iOS operating system. ARM 2 research participants are asked to: * For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project, * 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. * Additionally, once the Aktiia One App is released and for the next 10 years: * Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated. ARM 3: N3\~ 5'000 subjects. Research participants are non-Aktiia-G1 users (they do not own an Aktiia G1 device at their inclusion in the study), located in Switzerland, Germany or UK, and owning a smartphone with either iOS or Android operating system. ARM 3 research participants are asked to: * 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. * At their inclusion in the study: download the Aktiia One App to access G2C functionality with on-demand measurements at fingertip using the smartphone's camera. * For the next 10 years, starting at their inclusion in the research project and thereafter: * Take unlimited on-demand measurements with the Aktiia G2C feature.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-12
• Primary completion: 2035-05-31
• Completion: 2035-05-31
• First posted: 2024-11-01
• Last updated: 2025-05-14

Locations

2 sites across 2 countries: Switzerland, United Kingdom