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| Name | Class |
|---|---|
| Lindus Health | INDUSTRY |
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The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Each study subject will receive an Aktiia device and will use it continuously for 3 months. Study participants will have to complete 2 different surveys: one at baseline, and one after the 3 months of Aktiia device use to give their perception on the Aktiia device use as compared to other blood pressure monitors currently on the market. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure evolution over 12 weeks | Means, medians, standard deviations, and ranges for Blood Pressure readings and changes in Blood Pressure readings within the study population between week 1 to week 12. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor | Number of participants with preferences using Aktiia 24/7 device, as copared to Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor to monitor their blood pressure. | 3 months |
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Inclusion Criteria:
Adult participants aged 22 to 85 years old
A participant whose last blood pressure reading was within the last 12 months and was either:
People who use either an iOS or Android smartphone
People who have 2 arms
Able and willing to provide informed consent and to adhere to study procedures.
Exclusion Criteria:
Participants whose BP data submitted is >180 mm Hg systolic OR >120 mm Hg diastolic .
Participants with a self-reported known diagnosis of
Participants who take insulin
Participants who are on hemodialysis
Women who are self-reported to be pregnant
Participants whose arms shake uncontrollably or are paralyzed (cannot move)
Participants with upper arm circumference <22 cm or >42 cm
Participants with wrist circumference >23cm
Participation in another interventional clinical study or use of investigational drugs in the last 30 days.
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The final study population should cover the following phenotypes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindus Health | London | United Kingdom |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors. | Statistics on a potential correlation between Blood Pressure measurements and subjects responses to questionnaires regarding their lifestyle, socioeconomic environment and general health. | 3 months |