NCT05866445

Brief 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. 1.Study the safety and efficacy of static magnetic flux on blood pressure control in normal and hypertensive patients.
  2. 2.Incorporate this into a portable, wearable device to increase availability and outreach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 5, 2025

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

May 10, 2023

Last Update Submit

June 3, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Study Arms (2)

Hypertensive

EXPERIMENTAL

Hypertensive patients

Device: Wearable BP deviceDevice: 24-hour ambulatory blood pressure monitor

Normotensive participants

EXPERIMENTAL

Normotensive participants with no high blood pressure

Device: Wearable BP deviceDevice: 24-hour ambulatory blood pressure monitor

Interventions

Wearable BP deviceDEVICE

Wearable study BP device to be worn for 8 hours within study participation.

HypertensiveNormotensive participants
24-hour ambulatory blood pressure monitorDEVICE

24-hour ambulatory blood pressure monitor to be worn for 24-hours during study participation.

HypertensiveNormotensive participants

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Prior carotid stenosis or bruit
  • Presence of metallic implants (e.g. ICD, pacemaker, etc)
  • Pregnancy
  • Breast feeding
  • Allergy to device material/skin allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jie Sheng Foo, M.D.

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Study team and participants will be blinded to whether they are receiving the magnetic device or sham device. Delegated unblinded team member will assign study device to recruited participants.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

March 15, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 5, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)