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

NCT ID: NCT06670677

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2035-05-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Lifestyle survey completion

Intervention Type: OTHER

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.

Unlimited on-demand blood pressure measurements with G2C

Intervention Type: OTHER

For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated

Continual blood pressure measurements with G1

Intervention Type: OTHER

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.

Lifestyle survey completion

Intervention Type: OTHER

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.

Unlimited on-demand blood pressure measurements with G2C

Intervention Type: OTHER

For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated

Continual blood pressure measurements with G1

Intervention Type: OTHER

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.

Lifestyle survey completion

Intervention Type: OTHER

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.

Unlimited on-demand blood pressure measurements with G2C

Intervention Type: OTHER

For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aktiia SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fully remote study- no physical investigational site

Lausanne, , Switzerland

Site Status: RECRUITING

Fully remote study- no physical investigational site

London, , United Kingdom

Site Status: RECRUITING

Countries

Switzerland; United Kingdom

Central Contacts

Pascale Vermare

Role: CONTACT

pascale.vermare@aktiia.com

+41 32 552 20 52

Facility Contacts

Pr Wuerzner, MD

Role: primary

gregoire.wuerzner@chuv.ch

+41 21 314 02 23

Dr. Manish SAXENA, MD

Role: primary

m.saxena@qmul.ac.uk

0207 882 3856

Other Identifiers

SNCTP

Identifier Type: OTHER

Identifier Source: secondary_id

OBPM_FORESEE2024

Identifier Type: -

Identifier Source: org_study_id