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| ID | Type | Description | Link |
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| SNCTP | Other Identifier | KOFAM |
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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.
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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle survey completion | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors | 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 |
| 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 | Proportion of subjects with early hypertension awareness enabled by the fingertip spot-check feature of the Aktiia G2C device. | 10 years |
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Inclusion Criteria:
Adult subjects aged 21 to 85 years old
Subjects living in Switzerland, Germany or in the UK
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)
Subjects agreeing to follow the study procedures.
Exclusion Criteria:
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Any subjects that respect the study inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascale Vermare | Contact | +41 32 552 20 52 | pascale.vermare@aktiia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fully remote study- no physical investigational site | Recruiting | Lausanne | Switzerland |
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| Unlimited on-demand blood pressure measurements with G2C | Other | For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated |
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| Continual blood pressure measurements with G1 | Other | For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project. |
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| Fully remote study- no physical investigational site | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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