Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk (FORESEE2024)

May 12, 2025 updated by: Aktiia SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Lausanne, Switzerland
        • Recruiting
        • Fully remote study- no physical investigational site
        • Contact:
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Fully remote study- no physical investigational site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any subjects that respect the study inclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARM 1 G1 Aktiia users Android
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.
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.
ARM 2 G1 AKTIIA users iOS
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.
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.
ARM 3 non-Aktiia-G1-users Android & iOS
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors
Time Frame: 10 years
Strength and direction of the correlation coefficient between continuous blood pressure readings and various survey-derived factors such as sociodemographic variables, lifestyle habits, and health metrics.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip
Time Frame: 10 years
Proportion of subjects with early hypertension awareness enabled by the fingertip spot-check feature of the Aktiia G2C device.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aktiia SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

May 31, 2035

Study Completion (Estimated)

May 31, 2035

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBPM_FORESEE2024
  • SNCTP (Other Identifier: KOFAM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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