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

Recruiting

• Conditions: Blood Glucose Monitoring; Blood Pressure Measurement

• Registration Number: NCT06717646
• Lead Sponsor: National Heart Centre Singapore

Brief Summary

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.

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 Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore