Respiratory DisorderRE-VITALNCT06237322
Study of RE.DOCTOR Vitals® Software Accuracy
An observational study of Respiratory Disorder and Cardiovascular Diseases, run by RE.DOCTOR LLC at 1 site in United States.
Trial summary
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR Vitals software. Read more about this study
- Who is it for?
- Ages 13 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disorder, Cardiovascular Diseases, Diabetes
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The inclusion criteria are designed to ensure that participants are within a target age range, have access to the required technology, and are willing and able to actively participate in the study. The criteria also aim to exclude individuals with conditions or medications that could potentially confound the relationship between PPG waveforms and physiological parameters. Exclusion criteria are defined to ensure the safety and feasibility of participants in the study. Excluding individuals with specific health conditions or medications that could significantly affect PPG waveforms helps maintain the integrity of the data and the validity of the study outcomes.
Who may be able to join
- Age between 13-80 years.
- Ownership of a smartphone compatible with the designated data collection application.
- Willingness to use the smartphone application for continuous PPG data collection.
- Ability to provide informed consent for participation in the study.
- No known history of conditions or medications that significantly affect PPG waveforms (e.g., severe arrhythmias, use of beta-blockers).
- Healthy individuals and individuals with diagnosed CVD diseases, individuals with diagnosed pre-diabetes, diabetes I, diabetes II
Who cannot join
- Age outside the specified range of 13-80 years.
- Lack of ownership of a compatible smartphone.
- Inability or unwillingness to use the designated smartphone application for data collection.
- Known history of severe arrhythmias or use of medications affecting cardiovascular function.
- Any condition that, in the judgment of the investigator, may compromise the participant's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Re.Doctor
Albuquerque, New Mexico, 87110
Simon Halliday, 307-278-9811, simon@re.doctor
Daniel Lantape, +37441200356, daniel@re.doctor
About this study
Official title: An Observational Study Comparing RE.DOCTOR Vitals® Software Accuracy
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR 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?
Read more
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
Read the detailed description
1.1 Introduction Physiological parameters, such as glucose levels, blood pressure, blood oxygen, respiration rate, and pulse, are critical indicators of an individual's 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.
1.2 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.
1.3 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 individual's health status. The study's 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.
- Objectives
2.1 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.
2.2 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 RE.DOCTOR 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 participant's finger using the RE.DOCTOR 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 RE.DOCTOR 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.
- Medical subject headings
- Respiration Disorders, Cardiovascular Diseases, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Measurement: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. | |
| Cardio vascular diseases | Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Measurement: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. | |
| Pre-Diabetes | Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. | |
| Diabetes I | Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. | |
| Diabetes II | Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software
Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Systolic and Diastolic Blood Pressure Measurement taken with medical device
Systolic and Diastolic Blood Pressure Measurement taken with medical device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device
Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with RE.DOCTOR Vitals Software
Heart Rate Measurement taken with RE.DOCTOR Vitals Software
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with medical device
Heart Rate Measurement taken with medical device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with alternate PPG software device
Heart Rate Measurement taken with alternate PPG software device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with RE.DOCTOR Vitals Software
Respiration Rate Measurement taken with RE.DOCTOR Vitals Software
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with medical device
Respiration Rate Measurement taken with medical device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with alternate PPG software device
Respiration Rate Measurement taken with alternate PPG software device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software
Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with medical device
Blood Oxygen Measurement taken with medical device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with alternate PPG software device
Blood Oxygen Measurement taken with alternate PPG software device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with RE.DOCTOR Vitals Software
Blood Glucose Measurement taken with RE.DOCTOR Vitals Software
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with medical device
Blood Glucose Measurement taken with medical device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with alternate PPG software device
Blood Glucose Measurement taken with alternate PPG software device
Measured: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RE.DOCTOR LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237322
- Sponsor's protocol ID
- RDCTR51223
- Acronym
- RE-VITAL
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Comparing RE.DOCTOR Vitals® Software Accuracy
- ClinicalTrials.gov ID
- NCT06237322
- Acronym / sponsor ID
- RE-VITAL / RDCTR51223
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RE.DOCTOR LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR 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
Detailed description
1.1 Introduction Physiological parameters, such as glucose levels, blood pressure, blood oxygen, respiration rate, and pulse, are critical indicators of an individual's 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.
1.2 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.
1.3 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 individual's health status. The study's 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.
- Objectives
2.1 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.
2.2 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 RE.DOCTOR 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 participant's finger using the RE.DOCTOR 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 RE.DOCTOR 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Measurement: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
| Cardio vascular diseases | – | –Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Measurement: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
| Pre-Diabetes | – | –Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
| Diabetes I | – | –Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
| Diabetes II | – | –Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately. |
Who may qualify
- Ages
- 13 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The inclusion criteria are designed to ensure that participants are within a target age range, have access to the required technology, and are willing and able to actively participate in the study. The criteria also aim to exclude individuals with conditions or medications that could potentially confound the relationship between PPG waveforms and physiological parameters. Exclusion criteria are defined to ensure the safety and feasibility of participants in the study. Excluding individuals with specific health conditions or medications that could significantly affect PPG waveforms helps maintain the integrity of the data and the validity of the study outcomes.
Key inclusion criteria (6 listed)
- Age between 13-80 years.
- Ownership of a smartphone compatible with the designated data collection application.
- Willingness to use the smartphone application for continuous PPG data collection.
- Ability to provide informed consent for participation in the study.
- No known history of conditions or medications that significantly affect PPG waveforms (e.g., severe arrhythmias, use of beta-blockers).
Key exclusion criteria (5 listed)
- Age outside the specified range of 13-80 years.
- Lack of ownership of a compatible smartphone.
- Inability or unwillingness to use the designated smartphone application for data collection.
- Known history of severe arrhythmias or use of medications affecting cardiovascular function.
- Any condition that, in the judgment of the investigator, may compromise the participant's ability to complete the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software
Systolic and Diastolic Blood Pressure Measurement taken with medical device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Systolic and Diastolic Blood Pressure Measurement taken with medical device
Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device
Heart Rate Measurement taken with RE.DOCTOR Vitals Software
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with RE.DOCTOR Vitals Software
Heart Rate Measurement taken with medical device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with medical device
Heart Rate Measurement taken with alternate PPG software device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Heart Rate Measurement taken with alternate PPG software device
Respiration Rate Measurement taken with RE.DOCTOR Vitals Software
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with RE.DOCTOR Vitals Software
Respiration Rate Measurement taken with medical device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with medical device
Respiration Rate Measurement taken with alternate PPG software device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Respiration Rate Measurement taken with alternate PPG software device
Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software
Blood Oxygen Measurement taken with medical device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with medical device
Blood Oxygen Measurement taken with alternate PPG software device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Oxygen Measurement taken with alternate PPG software device
Blood Glucose Measurement taken with RE.DOCTOR Vitals Software
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with RE.DOCTOR Vitals Software
Blood Glucose Measurement taken with medical device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with medical device
Blood Glucose Measurement taken with alternate PPG software device
Time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.
Blood Glucose Measurement taken with alternate PPG software device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- RE.DOCTORLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disorder and Cardiovascular Diseases, run by RE.DOCTOR LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Halliday (+1-307-278-9811, simon@re.doctor), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software (time frame: Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.