Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237322
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-23
Brief Title:
Study of REDOCTOR Vitals Software Accuracy
Sponsor:
REDOCTOR LLC
Organization:
REDOCTOR LLC
Study Overview
Official Title:
An Observational Study Comparing REDOCTOR Vitals Software Accuracy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-VITAL
Brief Summary:
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography PPG waveforms collected via REDOCTOR Vitals software The study aims to collect a diverse and extensive dataset of PPG waveforms alongside traditional physiological measurements for the purpose of enhancing existing algorithms and machine learning models used in health monitoring The primary focus is on improving the accuracy and reliability of algorithms in interpreting PPG data to derive meaningful insights into physiological parameters The main questions it aims to answer are
How can extensive datasets of PPG waveforms be utilized to enhance existing algorithms and machine learning models
How do correlations between PPG waveforms and key physiological parameters such as glucose levels blood pressure heart rate respiration rate contribute to refining algorithms for more accurate and reliable health predictions
Participants will be asked to
Continuously monitor their health using smartphone applications
Allow the collection of PPG waveforms in diverse settings
Engage in tasks related to monitor health parameters using medically approved devices
How can extensive datasets of PPG waveforms be utilized to enhance existing algorithms and machine learning models
How do correlations between PPG waveforms and key physiological parameters such as glucose levels blood pressure heart rate respiration rate contribute to refining algorithms for more accurate and reliable health predictions
Participants will be asked to
Continuously monitor their health using smartphone applications
Allow the collection of PPG waveforms in diverse settings
Engage in tasks related to monitor health parameters using medically approved devices
Detailed Description:
11 Introduction Physiological parameters such as glucose levels blood pressure blood oxygen respiration rate and pulse are critical indicators of an individuals health Monitoring these parameters is crucial for early detection and management of various health conditions Photoplethysmography PPG has emerged as a non-invasive and convenient method for capturing real-time cardiovascular information In the context of this study the focus is on leveraging PPG data collected through smartphone applications to enhance the performance of existing algorithms and machine learning models
12 Rationale for the Study The rationale for this study lies in the potential of PPG data to contribute significantly to the refinement of algorithms and machine learning models for health monitoring While existing models have shown promise collecting more diverse and extensive datasets can address limitations and improve their accuracy and reliability By understanding the nuances of PPG waveforms in relation to key physiological parameters the investigators aim to advance the field of digital health and contribute to the development of more effective monitoring solutions
13 Significance of the Study The significance of this observational trial extends to the optimization of health monitoring algorithms Improving the accuracy of existing models through extensive data collection can lead to more reliable insights into an individuals health status The studys findings may influence the development of algorithmic solutions for personalized health monitoring paving the way for more precise and timely interventions based on real-time physiological data
2 Objectives
21 Primary Objective
Primary Objective
To collect a diverse and extensive dataset of PPG waveforms alongside traditional physiological measurements for the purpose of enhancing existing algorithms and machine learning models used in health monitoring The primary focus is on improving the accuracy and reliability of algorithms in interpreting PPG data to derive meaningful insights into physiological parameters
Rationale
The primary objective aligns with the overarching goal of optimizing existing algorithms By collecting a comprehensive dataset we aim to provide a robust foundation for refining and training machine learning models ultimately enhancing their capacity to accurately interpret and correlate PPG waveforms with key physiological parameters
22 Secondary Objectives
Secondary Objectives
To explore variations in PPG waveforms across diverse demographic groups and health conditions to ensure the generalizability of algorithmic improvements
To assess the impact of increased data volume on the performance and scalability of existing algorithms
To validate the optimized algorithms through comparison with traditional physiological measurements and clinical assessments
To engage participants in the study for feedback on the usability and acceptability of the smartphone application for continuous health monitoring
Rationale
The secondary objectives complement the primary goal by addressing specific aspects of algorithmic improvement Exploring demographic variations ensures that the refined algorithms remain applicable across diverse populations Assessing the impact of increased data volume and validating against traditional measurements contribute to the overall robustness and reliability of the optimized algorithms
Following informed consent participants will be assigned to sub-protocols for the assessment of the REDOCTOR Vitals Software The study aims to evaluate the accuracy and usability of the software in monitoring vital signs and blood glucose
Recruitment Criteria
Participants with the capacity to consent may be assigned to one or to more than one cohort
All individuals will undergo the following measurements
Blood Pressure Measurement
Heart Rate Measurement
Respiration Rate Measurement
Blood Oxygen Measurement
Blood Glucose
Measurement Procedures
Pre-measurement Observation
Demographic and medical history questions
Routine Observations
Measurements taken using standard clinical equipment Measurement taken using similar tools phone app using PPG PPG signal capture and health parameters estimated Heart rate Respiration Rate Blood Pressure Blood Oxygen Blood Glucose of the participants finger using the REDOCTOR Vitals app during approx 60 seconds
Blood glucose measurement using standard procedures
Post-measurement Observation
Completion of post-measurement observation questions
Questionnaire
A subset of participants from both sub-protocols will be asked to complete a questionnaire related to vital sign monitoring including preferences for REDOCTOR Vitals or other technologies
Overall Study Protocol
The study comprises two sub-protocols - Sub-protocol A for blood pressure heart rate and respiration rate measurements and Sub-protocol B for blood glucose measurements
12 Rationale for the Study The rationale for this study lies in the potential of PPG data to contribute significantly to the refinement of algorithms and machine learning models for health monitoring While existing models have shown promise collecting more diverse and extensive datasets can address limitations and improve their accuracy and reliability By understanding the nuances of PPG waveforms in relation to key physiological parameters the investigators aim to advance the field of digital health and contribute to the development of more effective monitoring solutions
13 Significance of the Study The significance of this observational trial extends to the optimization of health monitoring algorithms Improving the accuracy of existing models through extensive data collection can lead to more reliable insights into an individuals health status The studys findings may influence the development of algorithmic solutions for personalized health monitoring paving the way for more precise and timely interventions based on real-time physiological data
2 Objectives
21 Primary Objective
Primary Objective
To collect a diverse and extensive dataset of PPG waveforms alongside traditional physiological measurements for the purpose of enhancing existing algorithms and machine learning models used in health monitoring The primary focus is on improving the accuracy and reliability of algorithms in interpreting PPG data to derive meaningful insights into physiological parameters
Rationale
The primary objective aligns with the overarching goal of optimizing existing algorithms By collecting a comprehensive dataset we aim to provide a robust foundation for refining and training machine learning models ultimately enhancing their capacity to accurately interpret and correlate PPG waveforms with key physiological parameters
22 Secondary Objectives
Secondary Objectives
To explore variations in PPG waveforms across diverse demographic groups and health conditions to ensure the generalizability of algorithmic improvements
To assess the impact of increased data volume on the performance and scalability of existing algorithms
To validate the optimized algorithms through comparison with traditional physiological measurements and clinical assessments
To engage participants in the study for feedback on the usability and acceptability of the smartphone application for continuous health monitoring
Rationale
The secondary objectives complement the primary goal by addressing specific aspects of algorithmic improvement Exploring demographic variations ensures that the refined algorithms remain applicable across diverse populations Assessing the impact of increased data volume and validating against traditional measurements contribute to the overall robustness and reliability of the optimized algorithms
Following informed consent participants will be assigned to sub-protocols for the assessment of the REDOCTOR Vitals Software The study aims to evaluate the accuracy and usability of the software in monitoring vital signs and blood glucose
Recruitment Criteria
Participants with the capacity to consent may be assigned to one or to more than one cohort
All individuals will undergo the following measurements
Blood Pressure Measurement
Heart Rate Measurement
Respiration Rate Measurement
Blood Oxygen Measurement
Blood Glucose
Measurement Procedures
Pre-measurement Observation
Demographic and medical history questions
Routine Observations
Measurements taken using standard clinical equipment Measurement taken using similar tools phone app using PPG PPG signal capture and health parameters estimated Heart rate Respiration Rate Blood Pressure Blood Oxygen Blood Glucose of the participants finger using the REDOCTOR Vitals app during approx 60 seconds
Blood glucose measurement using standard procedures
Post-measurement Observation
Completion of post-measurement observation questions
Questionnaire
A subset of participants from both sub-protocols will be asked to complete a questionnaire related to vital sign monitoring including preferences for REDOCTOR Vitals or other technologies
Overall Study Protocol
The study comprises two sub-protocols - Sub-protocol A for blood pressure heart rate and respiration rate measurements and Sub-protocol B for blood glucose measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None