Clinical Trials Logo

Clinical Trial Summary

The goal of this study involving a wearable magnetic flux device is to study the impact of static magnetic flux on blood pressure control in hypertensive and normotensive populations. The main objectives are: 1. Study the safety and efficacy of static magnetic flux on blood pressure control in normal and hypertensive patients. 2. Incorporate this into a portable, wearable device to increase availability and outreach. Participants will be required to wear a wearable BP device, an ambulatory BP and answer a questionnaire for this study. Researchers will compare between hypertensive and normotensive groups to achieve objective of this study.


Clinical Trial Description

Hypertension is significant public health problem locally as well as internationally. Untreated hypertension results in much morbidity and mortality. In Singapore, there is a significant proportion of poorly controlled hypertensives, with its attendant risks. The compliance to antihypertensive medications has been reported at about only 50%. Several pertinent factors have been brought up including dislike of oral medications, having too many medications, cost of chronic medications and side effects of medications. Several studies have also pointed out the importance of combining various components (e.g. regimen simplification, patient behavioural modification, communication and education by health professionals) in order to improve antihypertensives adherence. This project aims to study the impact of static magnetic flux on blood pressure control. If efficacious, this may potentially provide an effective, non-invasive, non-pharmacological option for blood pressure control. In addition, the project aims to incorporate this static magnetic flux into a wearable, portable device to increase its availability and uptake. This may potentially increase compliance amongst patients who may be non-compliant to oral medications, and help reduce the attendant mortality and morbidity associated with hypertension. In this double-blind randomized control trial, 200 participants (140 hypertensive, 60 normotensive) will be recruited. Participants will be randomized into 2:1:1 to receive the original strength magnetic device vs half strength magnetic device (half the strength of the original magnetic device) vs the sham device respectively. The half strength arm will allow us to evaluate the dose-response effect of the magnetic field. The magnetic and sham devices will be made identical in appearance and numbered for assignment purposes during the period of the trial. Study team and participants will be blinded to whether they are receiving the magnetic device or sham device. The study participation will consist of 2 visits, an initial visit and device return visit. The participants will wear a 24hr ambulatory blood pressure (ABP) monitor for 24 hours, whereas the study device will be worn only for 8 hours. Prior to that, a blood pressure measurement will be taken at rest to confirm eligibility. Baseline ABP measurement will be taken for 3-4 hours, followed by the additional study device to be worn for the next 8 hours. Subsequently, participants will remove the study device leaving only the ABP monitor for the rest of the remaining hours. The first 3-4 hours will give an indication of the subject's baseline blood pressure. The next 8hr will give an indication of the effect of the device. The remainder 12-13hr will allow us to see the impact on blood pressure after the device is removed. The subjects will be required to complete a hardcopy questionnaire on their baseline demographics, characteristics, experience with the device, and any side effects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05866445
Study type Interventional
Source National Heart Centre Singapore
Contact Jie Sheng Foo, M.D.
Phone 67048961
Email foo.jie.sheng@singhealth.com.sg
Status Recruiting
Phase N/A
Start date March 15, 2023
Completion date April 30, 2024

See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A