Vital Signs Data Collection Using "Comestai" Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Data Collection Storage and Processing-Pulse rate
研究概览
简要总结
The purpose of the study is to verify and validate the parameters collected from mobile devices via the app named "Comestai" and from reference devices. The assessments considered to define comorbidities are included.. Specifically, collection of vital parameters (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation) through the "Comestai" Application via mobile phones (using photoplethysmographic method) and reference devices such as Withings-Blood Pressure Monitor Connect® (for Blood Pressure), Polar Verity Sense® (for Heart Rate), Masimo-finger sensor® (for Oxygen Saturation, Respiratory Rate), comparing and confirming them. Consent will be sought for the viewing and collection of blood test results that are normally included in evaluations for subjects with overweight and/or obesity and/or diabetes.
Estimated time required for each measurement recording: 10-15 minutes per subject
Total number of subjects: 3000
详细描述
Early detection of variations in vital parameters allows for the identification of changes in patients' health status and the provision of recommendations for therapeutic adjustments. The application named "Comestai" is a non-invasive and easy-to-use tool that enables the measurement of vital parameters. The app allows users to simultaneously measure vital parameters such as Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (SpO2), and Blood Pressure (BP) using the photoplethysmographic method with the front camera of a mobile device.
The use of simultaneous vital parameter measurement systems like apps can enhance self-monitoring of health status and improve patient care. In this study, vital parameters will be measured using the "Comestai" application and compared and validated with measurements from standard clinical practice devices.
Consent will be sought for the viewing and collection of biochemical evaluation results typically required for individuals with overweight and/or obesity and/or diabetes.
"Comestai" Application: This wellness app allows for non-invasive measurement of vital parameters, enabling users to detect SpO2, HR, RR, and BP by looking at the front camera of a mobile device ("By Face"). The measurement method used is Remote Photoplethysmography (rPPG).
This is a prospective, open-label, study to collect vital parameters using the Comestai application by looking at the front camera of a mobile device ("By Face"). The measurement method of the app is Remote Photoplethysmography (rPPG).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior to enrollment in this study, subjects must meet all the following inclusion criteria:
- •Subject must have the ability to understand and provide written informed consent.
- •Male or Female subject ≥16 and ≤65 of age.
- •Subject must be willing and able to comply with study procedures.
排除标准
- •Subjects will be excluded from the study if any of the following conditions are present:
- •Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study.
- •Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.
- •Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.
- •Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.
- •Subject unfit to participate in the study to the judgment of the investigator.
- •In addition to the Inclusion/Exclusion criteria, the 70% of target population should include adult subjects with at least one of the following:
- •Pre-diabetes or diabetes HbA1C 5.7-13%
- •>30% of subjects with HbA1C 5.7-6.4%
- •>30% of subjects with HbA1C >6.4%
- •Hypertension with systolic measurements above 130 mmHg
- •>40% of subjects with systolic BP >130 mmHg
- •>20% of subjects with systolic BP >160 mmHg
- •Total cholesterol: >40% of subjects with >200 mg/dl and/or LDL above 130 mg/dl
- •Atrial fibrillation 1%
- •Smokers ~ 20-30% of all subjects in the study
- •Note: the same subject can have more than one of the above medical conditions. It is preferred that subjects will be treatment- naive for the medical condition they suffer from or are not under treatment at the time of participation (e.g. a subject who suffers from hypertension has not started his treatment to lower his blood pressure).
结局指标
主要结局
Data Collection Storage and Processing-Pulse rate
时间窗: 15 minutes for data collection
Collect, verify and validate Pulse rate (beats per minute) in data using the Comestai application and reference devices. Pulse rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
Data Collection Storage and Processing-Respiratory rate
时间窗: 15 minutes for data collection
Collect, verify and validate Respiratory rate (breaths per minute) in data using the Comestai application and reference devices. Respiratory rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
Data Collection Storage and Processing-Oxygen saturation
时间窗: 15 minutes for data collection
Collect, verify and validate Oxygen saturation (percentage) in data using the Comestai application and reference devices. Oxygen saturation data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
Data Collection Storage and Processing-Blood pressure
时间窗: 15 minutes for data collection
Collect, verify and validate Blood pressure (mmHg) in data using the Comestai application and reference devices. Blood pressure data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.
次要结局
- Data Collection Storage and Processing-Hemoglobin(15 minutes for data collection)
- Data Collection Storage and Processing-Hemoglobin glycosylated(15 minutes for data collection)
研究者
Valeria Calcaterra
Clinical Professor
Buzzi Children's Hospital