Using Laser Spatiotemporal Photoplethysmogram and Computational Method for Management of Chronic Disorders. (LSPPG)

December 3, 2024 updated by: National Heart Centre Singapore

Laser Spatiotemporal Photoplethysmogram and Computational Method for Extended Chronic Cardiometabolic Therapeutic Care

This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.

Study Overview

Status

Recruiting

Conditions

Detailed Description

NHC inpatients (Group A) Patients will be required to put on the LSPPG wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Study team member will assist the patient to take daily measurement.

NHC Outpatients scheduled for 24-Hour ABP monitoring (Group B) Patients will wear the LSPPG wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore
        • Contact:
        • Contact:
          • Alex Tan Weixian, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from National Heart Centre Singapore

Description

Inclusion Criteria:

  • Above 21 years of age
  • Sufficient language skills in English, Chinese, Malay or Tamil
  • Provided informed consent

Exclusion Criteria:

  • Skin sensitivity to adhesives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Inpatient
Patients warded under National Heart Centre Singapore
Outpatients
Patients scheduled for 24-hour Ambulatory Blood Pressure Monitoring at National Heart Centre Singapore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparable results to traditional methods
Time Frame: 24 Hours
Perform comparably to the 24-hour ambulatory blood pressure meters and continuous glucose monitors (CGM) to establish hypertension and blood glucose changes
24 Hours
Improve efficiency
Time Frame: 24 Hours
Provide real time feedback to patients and healthcare providers to individualize hypertension / hyperglycemic treatment
24 Hours
Lifestyle Improvement
Time Frame: 24 Hours
Consider patient lifestyle changes and reduce medication burden, especially in the elderly when blood pressure control is optimal.
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/2724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure Measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe