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

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorXim Limited

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifelight

    Device

    Contactless Vital Signs Measurement via RPPG

  • Blood Pressure Cuff

    Device

    Standard Blood Pressure Cuff Digital

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Cuff ArmActive comparator 1 intervention
Group B: LifeLight ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood Pressure Measurement Non Inferiority

Demonstrate non-inferiority of Lifelight® HBPM compared to cuff-based HBPM for achieving blood pressure control. (5 mmHg non-inferiority margin)

Time frame
3 Months

Secondary outcomes

1

Adherance to Blood Pressure Measurement

Determine acceptability and adherence of Lifelight® for HBPM in comparison to cuff-based HBPM methods.

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xim Limited

Lead sponsor

Barts & The London NHS Trust

Collaborator

Mind Over Matter Medtech Ltd

Collaborator

Health Innovation Wessex

Collaborator