Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
Recruiting · NCT06325384 · Interventional (participants receive a specific treatment) · Lead sponsor: Xim Limited
View the official record on ClinicalTrials.gov →Interventions studied
Blood Pressure CuffLifelight
What this trial is about
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
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square, - London, United Kingdom