SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Plumpness index
研究概览
简要总结
Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress.
SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring.
The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual.
The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions.
To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior.
Reference tests include
- Physician visit
- Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function
- Laboratory profile and exhaled gas composition
- Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress).
Wize Mirror measures include
- 3D reconstruction of face images for roundness, color, stress and fatigue
- Heart and respiratory rate
- Detection of skin sugar metabolism end-products and of eye lipid deposits
- Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.
详细描述
Cardio--metabolic (CM) risk is a cluster of risk factors indicative of a patient's overall risk for cardiovascular diseases (CVD), the leading cause of morbidity and mortality worldwide and type-2 diabetes. CM risk factors include obesity, physical inactivity, smoke, alcohol abuse, abnormal lipid metabolism, hyper-glycaemia and arterial hypertension.
Educational programs and lifestyle interventions represent effective tools to improve the risk profile but they need time consuming and expensive counselling and supervision of various health professionals . A rational alternative to intensive individual coaching is the use of systems for self-learning and self-monitoring, to help people change and maintain a healthy lifestyle through tailored suggestions about nutrition, weight control, physical activity, fatigue, and stress.
SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face into measures and descriptors to be automatically evaluated by a computerized application, an interactive smart mirror, which seamlessly integrates contactless sensors, such as 3D optical sensors, a multispectral camera, gas detection sensors, and microphones and a touch-screen interface for user's interactions and output visualization.
This "Wize Mirror" collects data in the form of videos, images and gas concentration signals, and extracts a number of biometric, morphometric, colorimetric, and compositional descriptors that represent individual's facial signs. The integration of such descriptors constitute a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary about this index enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor to provide useful suggestions on correct lifestyle self-monitoring.
The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of an individual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blood pressure and heart rate measure after 10 minutes lying without treatment: 95 mmHg<Systolic Blood Pressure<160 mmHg; 45 mmHg<Diastolic Blood Pressure<90 mmHg; 40 bpm<Heart rate<100bpm.
- •Broad range of CM risk profile
- •Undergoing medical examination at the inclusion visit
- •Interested and willing to change their lifestyle by decreasing body weight and/or increasing physical fitness and/or improving their well-being following medical advice
排除标准
- •History of overt disease, including hypertension, diabetes, dyslipidemia requiring drug treatment
- •Clinical or laboratory findings (lipid, glucose,liver and kidney profile, hemoglobin) at the inclusion visit suggesting any pathological condition requiring treatment
- •Chronic medical treatment other than contraception
- •Declared pregnancy and breastfeeding
- •Claustrophobia
- •Minor or adult under guardianship
- •Expected poor compliance
- •Subject who has exceeded the maximum foreseen compensation for participation in research protocols
结局指标
主要结局
Plumpness index
时间窗: 3 months
a geodetic measure of the roundness of the face as proxy for overweight
次要结局
- Change in % skin autofluorescence by MultiSpectral analysis(3 months)
- Change in % Thermal reactive skin hyperemia by MultiSpectral analysis(3 months)
- Change in % suborbital skin fat content by MultiSpectral analysis(3 months)
- Intraclass Correlation Coefficient of % suborbital skin fat content by MultiSpectral analysis for temperature changes(Day 15)
- Change in Heart Systematic COronary Risk Evaluation (SCORE)(3 months)
- Change in HOMA-insulin resistance (IR) index(3 months)
- Change in Fatty Liver Index(3 months)
- Change in FINDRISC score(3 months)
- Intraclass Correlation Coefficient of % skin autofluorescence by MultiSpectral analysis for temperature changes(Day 15)
- Well being index(3 months)
- Intraclass Correlation Coefficient of % skin autofluorescence by MultiSpectral analysis for light changes(Day 15)
- Intraclass Correlation Coefficient of % suborbital skin fat content by MultiSpectral analysis for light changes(Day 15)
- Intraclass Correlation Coefficient of Thermal reactive skin hyperemia by MultiSpectral analysis for temperature changes(Day 15)
- Intraclass Correlation Coefficient of Thermal reactive skin hyperemia by MultiSpectral analysis for light changes(Day 15)
- Score in the System Usability Scale(3 months (end of study visit))