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临床试验/NCT07491978
NCT07491978尚未招募不适用

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

Tarumanagara University0 个研究点目标入组 1,000 人开始时间: 2026年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Agreement of rPPG-Derived Vital Signs With Standardized Clinical Measurements

研究概览

简要总结

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.

详细描述

Remote photoplethysmography (rPPG) is an emerging non-contact optical technology that enables extraction of physiological signals from facial video using standard cameras. This approach has gained increasing attention in telemedicine due to its scalability, cost-effectiveness, and ability to perform remote health screening. Recent advancements in artificial intelligence (AI) have further expanded the potential of rPPG beyond basic vital sign monitoring to include estimation of cardiometabolic biomarkers and health risk indices. However, comprehensive validation of rPPG-based systems against standardized clinical measurements, laboratory biomarkers, and psychological parameters remains limited, particularly in low- and middle-income settings such as Indonesia. Given the high burden of cardiometabolic diseases in urban populations like Jakarta, evaluating the accuracy and feasibility of AI-based facial scanning technologies is essential to support early detection and digital health integration.

Specific Objectives

  1. To assess the agreement between rPPG derived vital signs (heart rate, respiratory rate, blood pressure, SpO₂) and corresponding measurements obtained from standardized physical examination by trained personnel and validated medical devices
  2. To determine the degree of concordance between rPPG based estimates and laboratory values of hemoglobin, blood glucose, HbA1c, LDL, HDL, triglycerides, and total cholesterol.
  3. To analyze the association between rPPG derived physiological parameters and levels of depression, anxiety, and stress as measured by the DASS 21 questionnaire.
  4. To calculate mean arterial pressure (MAP), ASCVD risk scores, and heart age from rPPG outputs and to compare these indices with those derived from standard clinical and laboratory data.
  5. To develop and preliminarily evaluate exploratory algorithms using rPPG video data to estimate kidney function, liver function, muscle mass, visceral fat, body weight, body height, body mass index, and subcutaneous fat as potential screening parameters.

Methods This study will employ a multicenter observational design conducted across selected subdistricts in Jakarta and expanded to the Jabodetabek region. Adult participants will undergo comprehensive assessment including psychological questionnaires (DASS, PHQ, GAD), anthropometric measurements, body composition analysis, spirometry, muscle strength testing, and venous blood sampling. Blood samples will be analyzed using POCT (≤30 minutes) and ISO-standardized clinical laboratory methods. In parallel, participants will undergo a non-contact facial scan, generating rPPG-based outputs including vital signs, hemodynamic indices, and AI-estimated biomarkers. Statistical analysis will include Bland-Altman agreement analysis, Cohen's kappa for categorical variables, correlation analysis, and machine learning performance metrics (MAE, MSE, RMSE, R²).

Expected Results It is expected that rPPG-based measurements will demonstrate good agreement with standard clinical measurements for core vital signs (heart rate, respiratory rate, SpO₂), with moderate agreement for blood pressure and selected biomarkers. AI-based models are anticipated to show acceptable predictive performance for certain metabolic parameters and exploratory variables, supporting the feasibility of rPPG as a screening tool. The study is also expected to identify key confounding factors, such as skin tone and demographic variability, influencing signal accuracy.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Agreement of rPPG-Derived Vital Signs With Standardized Clinical Measurements

时间窗: At a single study visit during baseline assessment (cross-sectional measurement)

The primary outcome is the level of agreement between vital signs obtained from the artificial intelligence-based remote photoplethysmography (rPPG) facial scan and corresponding reference measurements obtained through standardized physical examination and validated medical devices. The vital signs assessed include heart rate, respiratory rate, blood pressure, and oxygen saturation (SpO₂). Agreement will be evaluated using paired comparisons between index and reference methods, primarily through Bland-Altman analysis, including mean difference (bias) and limits of agreement. This outcome is intended to determine the clinical validity of AI as a non-contact screening tool for core physiological parameters in adults.

Concordance Between rPPG-Derived Biomarker Estimates and Standard Laboratory Measurements

时间窗: At a single study visit during baseline assessment (cross-sectional measurement)

The outcome measures the degree of concordance between biomarker estimates derived from remote photoplethysmography (rPPG)-based analysis and corresponding reference values obtained from standardized point-of-care testing and clinical laboratory methods. Biomarkers assessed include hemoglobin, blood glucose, glycated hemoglobin (HbA1c), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, and total cholesterol. Concordance will be evaluated using correlation analysis and agreement statistics, including Bland-Altman analysis and appropriate regression-based performance metrics.

Association Between rPPG-Derived Physiological Parameters and Psychological Status

时间窗: At a single study visit during baseline assessment (cross-sectional measurement)

The outcome measures the association between physiological parameters derived from remote photoplethysmography (rPPG) and psychological status assessed using the DASS-21, PHQ and GAD. Physiological parameters include heart rate, respiratory rate, heart rate variability, and other autonomic-related indices. Psychological outcomes include depression, anxiety, and stress scores. The relationship will be analyzed using correlation and regression analyses to evaluate the extent to which rPPG-derived signals reflect mental health status.

Agreement of rPPG-Derived Cardiovascular Risk Indices With Standard Clinical Calculations

时间窗: At a single study visit during baseline assessment (cross-sectional measurement)

The outcome measures the level of agreement between cardiovascular risk indices derived from remote photoplethysmography (rPPG)-based parameters and those calculated using standard clinical and laboratory data. The indices include mean arterial pressure (MAP), atherosclerotic cardiovascular disease (ASCVD) risk score, and heart age. Agreement will be evaluated using Bland-Altman analysis, correlation coefficients, and classification concordance where applicable, to determine the reliability of rPPG-based estimations in reflecting established cardiovascular risk assessments.

次要结局

  • Predictive Performance of rPPG-Based Models for Estimation of Organ Function and Body Composition(At a single study visit during baseline assessment (cross-sectional measurement))

研究者

发起方
Tarumanagara University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yohanes Firmansyah, dr, MH, MM

Principal Investigator

Tarumanagara University

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