Evaluating a Contactless Monitor for Blood Pressure at Home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares the effectiveness of a contactless vital signs monitor, Lifelight®, with traditional blood pressure cuffs for home monitoring in patients with uncontrolled hypertension. Participants aged 18 and older will be recruited from hypertension clinics and randomly assigned to use either the Lifelight® device or a standard BP cuff. Over six months, they will record their blood pressure readings and adherence to the monitoring schedule, while also tracking healthcare resource use and feedback on their monitoring method. The study aims to assess the feasibility and clinical outcomes of these two monitoring approaches.

Why it matters

Who can join: the full rules

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's running

• William Harvey Heart Centre, Queen Mary Queen Mary University of London, Charterhouse Square,
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Laurence Pearce, BSc, MBA
• Email: laurence@xim.ai
• Phone: 07803950356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.