HypertensionNCT05866445
An Updated Wearable Magnetic Flux Device to Optimize Blood Pressure Control
A study testing Wearable BP device and 24-hour ambulatory blood pressure monitor in people with Hypertension, run by National Heart Centre Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Wearable BP device and 24-hour ambulatory blood pressure monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Mar 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For normotensive patients, Systolic Blood Pressure 100-139mmHg/ Diastolic Blood Pressure 50-89mmHg
- For hypertensive patients, SBP 140-180mmHg, DBP 90-110mmHg (no change in blood pressure medications in last one month) OR Hypertensive patients with stable blood pressure (SBP not <100, DBP not <50) well controlled on medication
Who cannot join
- SBP <100mmHg, DBP<50mmHg
- SBP>180mmHg, DBP >110mmHg
- Recent change (<1month) in blood pressure medications
- Prior stroke
- Prior ischemic heart disease
- Prior peripheral vascular heart disease
Show all 11Show fewer
- Prior carotid stenosis or bruit
- Presence of metallic implants (e.g. ICD, pacemaker, etc)
- Pregnancy
- Breast feeding
- Allergy to device material/skin allergy
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National Heart Centre Singapore
Singapore, Singapore, 169609
About this study
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:
- Study the safety and efficacy of static magnetic flux on blood pressure control in normal and hypertensive patients.
- 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.
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- Wearable BP device, 24-hour ambulatory blood pressure monitor
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable BP deviceDevice
Wearable study BP device to be worn for 8 hours within study participation.
24-hour ambulatory blood pressure monitorDevice
24-hour ambulatory blood pressure monitor to be worn for 24-hours during study participation.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive | Experimental | Hypertensive patients Receives: Device: Wearable BP device; Device: 24-hour ambulatory blood pressure monitor |
| Normotensive participants | Experimental | Normotensive participants with no high blood pressure Receives: Device: Wearable BP device; Device: 24-hour ambulatory blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure measurement after wearing study BP device
The investigators will be assessing the 24Hours ambulatory blood pressure monitor report with hourly averages to determine the outcome. Blood pressure measurements will reflect whether the wearable BP device has any impact on the participants' blood pressure before, during and after the participants wear the device.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Mar 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants from 2 different groups (Hypertensive and Normotensive groups) 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Sheng Foo, M.D., Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866445
- Sponsor's protocol ID
- 2021/2396
- Status last verified
- Nov 2024
- First submitted
- 10 May 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Updated Wearable Magnetic Flux Device to Optimize Blood Pressure Control
- ClinicalTrials.gov ID
- NCT05866445
- Acronym / sponsor ID
- 2021/2396
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Study the safety and efficacy of static magnetic flux on blood pressure control in normal and hypertensive patients.
- 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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants from 2 different groups (Hypertensive and Normotensive groups) 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.
| Arm | Type | Receives |
|---|---|---|
| Hypertensive | Experimental | Device: Wearable BP device, Device: 24-hour ambulatory blood pressure monitorHypertensive patients |
| Normotensive participants | Experimental | Device: Wearable BP device, Device: 24-hour ambulatory blood pressure monitorNormotensive participants with no high blood pressure |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For normotensive patients, Systolic Blood Pressure 100-139mmHg/ Diastolic Blood Pressure 50-89mmHg
- For hypertensive patients, SBP 140-180mmHg, DBP 90-110mmHg (no change in blood pressure medications in last one month) OR Hypertensive patients with stable blood pressure (SBP not <100, DBP not <50) well controlled on medication
Key exclusion criteria (11 listed)
- SBP <100mmHg, DBP<50mmHg
- SBP>180mmHg, DBP >110mmHg
- Recent change (<1month) in blood pressure medications
- Prior stroke
- Prior ischemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable BP deviceWearable study BP device to be worn for 8 hours within study participation. | Device | Hypertensive, Normotensive participants |
| 24-hour ambulatory blood pressure monitor24-hour ambulatory blood pressure monitor to be worn for 24-hours during study participation. | Device | Hypertensive, Normotensive participants |
Primary outcome
Change of blood pressure measurement after wearing study BP device
Time frame: 24 hours
The investigators will be assessing the 24Hours ambulatory blood pressure monitor report with hourly averages to determine the outcome. Blood pressure measurements will reflect whether the wearable BP device has any impact on the participants' blood pressure before, during and after the participants wear the device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Sheng Foo, M.D. principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable BP device and 24-hour ambulatory blood pressure monitor in people with Hypertension, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure measurement after wearing study BP device (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.