SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Arm 1 Reproducibility and repeatability study (to be performed at the French site Lyon only).

      The reproducibility and repeatability study will evaluate whether Wize Mirror measurements
      are influenced by meals, light and temperature conditions in 6 healthy volunteers Data will
      be acquired during 4 modules corresponding to different use conditions of the mirror

        1. - Changes in the fasting state Under artificial lights and at environment temperature
           (18-20°C), Wize Mirror measurements will be acquired at baseline in the fasting state
           and at 30, 60 and 120 minutes after a standardized breakfast during three consecutive
           days.

        2. - Changes in light conditions Wize Mirror measurements will be performed at baseline
           under artificial lights and at environment temperature (18-20°C) then at 30' under
           artificial lights and at environment temperature (18-20°C) for 3 times consecutively
           during the same morning with 20 minutes interval between acquisitions.

        3. - Changes in temperature conditions Wize Mirror measurements will be performed at
           baseline under artificial lights and at environment temperature (18-20°C) then at 30'
           under artificial lights and at temperature increased to 28- 30°C, for 3 times
           consecutively during the same morning with 20 minutes interval between acquisitions.

        4. - Simultaneous changes in light and temperature conditions Wize Mirror measurements will
           be performed at baseline under artificial lights and at environment temperature
           (18-20°C) then at 30' under natural lights and at temperature increased to 28- 30°C, in
           6 volunteers for 3 times consecutively during the same morning with 20 minutes interval
           between acquisitions. The visit will last approximately 3 hours. A breakfast will be
           offered at the end of the visit.

      To assess whether measurements are stable over short time spans one of the 6 volunteers will
      undergo a last visit for the repeatability study in the fasting state. Wize Mirror
      measurements will be performed at T0 under artificial lights and at environment temperature
      (18-20°C) for 10 consecutive times with a 30 minutes interval between acquisitions.

      During each visit the following Wize Mirror measurements will be performed:

        -  face morphometry through 3D reconstruction of face images

        -  colorimetric analysis

        -  heart rate and respiratory rate

        -  autofluorescence detection of protein glycation

        -  skin cholesterol content

        -  thermal-induced vasodilation by application of warm air at 42°C temperature to the cheek
           to study microvascular function

        -  face expression of stress and fatigue through 3D reconstruction of face images

        -  exhaled gas analysis for ethanol and carbon dioxide

      Arm 2 Validation study. The validation study will check data measured from the Wize Mirror
      against reference clinical tests in 60 healthy volunteers. To verify whether the Wize Mirror
      is able to detect variations in physical and emotional health status with appropriate
      lifestyle changes, measurements will be cross-checked at enrolment and after 3 months of
      personalized suggestions for healthy behavior.

      Healthy volunteers will undergo at recruitment the following for user profiling for baseline
      CM risk

        1. Medical history,

        2. Physical examination: anthropometric measurements (body height, body weight, waist
           circumference, hip circumference) and vital signs (heart/respiratory rate, blood
           pressure)

        3. Body composition (lean mass, fatty mass) by air displacement pletysmography

        4. Energy expenditure by indirect calorimetry

        5. Peripheral venous blood sampling: hemoglobin, creatinine,Total, HDL, LDL cholesterol,
           triglycerides, gamma glutamyl transferase, aspartate aminotransferase (AST), alanine
           aminotransferase (ALT), bilirubin, glucose, insulin, HbA1c

        6. Skin accumulation of Advanced Glycation End Products (AGEs)

        7. Peripheral arterial tonometry for endothelium-dependent vasodilatation

        8. Pulse oxymetry for oxygen saturation

        9. Exhaled gas sampling

       10. Psychological , knowledge and nutritional tests

             1. measures of psychological well being: Life Orientation Test-Revised (LOT-R);
                General self efficacy scale (GSES)

             2. measures of anxiety, depression: Beck Anxiety Inventory (BAI); Beck Depression
                Inventory (BDI-II)

             3. measures of quality of life: Perceived Stress Scale (PSS); Short Form (SF)-12
                Health Survey; Insomnia Severity Index (ISI) ; World Health Organization (WHO)
                (Five) Well Being Index

             4. measures of eating and smoking behaviour and physical activity: WHO STEPwise
                approach to noncommunicable disease risk factor surveillance (STEPS); Audit C
                Alcohol ; Fagenstrom's test; International Physical Activity Questionnaire (IPAQ)
                physical activity; Dietary Approaches to Stop Hypertension (DASH) dietary regimen

             5. measure of motivation to change: Motivation to change physical activity, physical
                activity (MAC2-AF R) ; motivation to change , nutrition (MAC2- AL R)

             6. measures of health literacy: Newest Vital Sign (NVS) Cardio-metabolic risk scores
                will be calculated to estimate the CM risk profile

             1. Heart-SCORE

             2. Fatty-liver-Index (FLI)

             3. Finnish Type 2 Diabetes Risk Score (FINDRISC)

             4. Homeostasis Model Assessment (HOMA) index

      Data acquisition to derive computational descriptors for Wize Mirror functioning will include
      image (still pictures, videos) acquisition in visible light and infrared band before and
      after thermal stimulation at 42° C and Exhaled gas sampling using the "Wize Sniffer". During
      each visit the following Wize Mirror measurements will be performed:

        -  face morphometry through 3D reconstruction of face images

        -  colorimetric analysis

        -  heart rate and respiratory rate

        -  autofluorescence detection of protein glycation

        -  skin cholesterol content

        -  thermal-induced vasodilation by application of warm air at 42°C temperature to the cheek
           to study microvascular function

        -  face expression of stress and fatigue through 3D reconstruction of face images

        -  exhaled gas analysis for ethanol and carbon dioxide

      Healthy volunteers will then undergo periodically (minimum time interval 2 weeks) face image
      acquisition, exhaled gas sampling and they will fill through the Wize Mirror screen lifestyle
      questionnaires till week 12 (end of study). At the end of study visit they will repeat
      baseline assessments and fill in a questionnaire to evaluate Wize Mirror ease of use and
      acceptability.

      The changes in Wize Mirror measurements obtained at baseline and end of study will be
      correlated with changes in body weight, waist circumference and Fatty liver index.
      Relationship with quality of life, or other well-being questionnaire SCORE, standard
      biochemistry and specific tests will be also assessed.
    

Intervention name(s): Wize Mirror
Intervention type(s): Other
Intervention description(s): Interactive mirror which integrates contactless sensors and a touch screen interface to derive a semeiotic model of the face with reference to cardiometabolic risk in healthy subjects
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: obesity; dysglycemia; hypercholesterolemia; lifestyle; smoking; physical activity