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Clinical Trials in the UK / NCT06670677
Recruiting Observational

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

NCT06670677 · tracked via the Priya Life Science UK tracker
Sponsor
Aktiia SA
Phase
Observational
Started
2025-05-12
Last updated
2025-05-14

Condition(s) studied

HypertensionCardiovascular RiskBlood Pressure Check (Hypertension Screening)

Investigational drug(s) / intervention(s)

Lifestyle survey completionUnlimited on-demand blood pressure measurements with G2CContinual blood pressure measurements with G1

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.

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
85 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Fully remote study- no physical investigational site Lausanne Switzerland Recruiting
Fully remote study- no physical investigational site London United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06670677 on ClinicalTrials.gov ↗ ← All trials in the UK