Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment: Agreement With Clinical, Laboratory, and Psychological Parameters in an Urban Population
Trial ID: NCT07491978
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-04-24
Completion date: 2027-03-30
Sponsor: Tarumanagara University
Conditions: Metabolic Syndrome; Hypertension; Diabetes (DM); Tachycardia; ASCVD; Depression Disorder; Anxiety; Stress (Psychology); Obesity & Overweight; Cardiometabolic Risk Factors; Cardiometabolic Health Indicators; Sleep; Wellness
Enrollment: 1000
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera.

The main questions this study aims to answer are:

1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels?
2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels?
3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression?

Participants will take part in several simple and mostly non-invasive procedures:

1. Answer questionnaires about their mental health and daily habits
2. Have basic health checks, such as blood pressure, heart rate, and body measurements
3. Provide a blood sample for laboratory testing
4. Complete a facial scan using a camera for about 1 to 3 minutes

Researchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works.

This study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.

Eligibility criteria:
Inclusion Criteria:

1. Adults aged ≥18 years.
2. Able and willing to provide written informed consent.
3. Able to comply with study procedures, including face scan, physical examination, blood sampling, and questionnaire completion.
4. Clinically stable at the time of assessment.

Exclusion Criteria:

1. Facial conditions affecting the region of interest (ROI), such as injury, deformity, or impaired circulation, that may interfere with rPPG signal acquisition.
2. Presence of facial tattoos or coverings that obstruct optical signal detection.
3. Inability to remain still or comply with measurement procedures during data acquisition.
4. Severe medical conditions that preclude safe participation, as judged by the investigator.
5. Incomplete data or withdrawal of consent during the study.

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Outcomes:
Agreement of rPPG-Derived Vital Signs With Standardized Clinical Measurements; Concordance Between rPPG-Derived Biomarker Estimates and Standard Laboratory Measurements; Association Between rPPG-Derived Physiological Parameters and Psychological Status; Agreement of rPPG-Derived Cardiovascular Risk Indices With Standard Clinical Calculations