New treatment option for Hypertension
Official title Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
ClinicalTrials.gov ID: NCT06325384
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Participants who are unwilling to undertake self-monitoring or lacking capacity.
- Partners or spouses of individuals already assigned by chance in the trial
- Patients on dialysis or known ESRD (End-stage kidney disease)
See the full eligibility 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.
- 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...
- Participants who are unwilling to undertake self-monitoring or lacking capacity.
- Partners or spouses of individuals already assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.