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Recruiting Not applicable

Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care

NCT06325384 · tracked via the Priya Life Science UK tracker
Sponsor
Xim Limited
Phase
Not applicable
Started
2025-02-10
Last updated
2025-04-03

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

LifelightBlood Pressure Cuff

Lifelight: Contactless Vital Signs Measurement via RPPG

Blood Pressure Cuff: Standard Blood Pressure Cuff Digital

Study summary

A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * 18 years or older * Established diagnosis of hypertension * Uncontrolled hypertension defined as office blood pressure ≥140/90mmHg. * Patients who are pharmacologically treated for their hypertension should have been on stable medication for at least 4 weeks. * Ability to read, write and understand English to complete the study. * Capacity to give free, valid informed consent. * A compatible device that supports Lifelight®, as per xim Ltd.'s constantly updating list of compatible devices. If this is not possible, xim Ltd, might provide a similar device for the purpose of the study. Exclusion Criteria: * Patients with stage III hypertension with office blood pressure ≥180/120mmHg or it is unsafe to keep them in the study, in the opinion of the investigators. * Individuals with diagnosed atrial fibrillation. * Patients with significant arrhythmias such as SVT (Supraventricular tachycardia) or any rhythm that has significant impact on their BP, poor perfusion, pregnancy, pre-eclampsia, deformities or abnormalities which may prevent proper application of a BP cuff, or skin disorders (anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria) * Participants who are unwilling to undertake self-monitoring or lacking capacity. * Partners or spouses of individuals already randomised in the trial * Patients on dialysis or known ESRD (End-stage kidney disease) * Patients on active cancer treatment * Terminally ill patients * Patients who cannot tolerate sitting for up to one hour.

Primary outcome measure(s)

  • Blood Pressure Measurement Non Inferiority — 3 Months
    Demonstrate non-inferiority of Lifelight® HBPM compared to cuff-based HBPM for achieving blood pressure control. (5 mmHg non-inferiority margin)

Trial sites (1)

FacilityCityRegionStatus
William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square, London United Kingdom Recruiting
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 NCT06325384 on ClinicalTrials.gov ↗ ← All trials in the UK