NOT_YET_RECRUITING
Study of 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? 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
Conditions:
🦠 Respiratory Disorder 🦠 Cardiovascular Diseases 🦠 Diabetes 🦠 Pre-Diabetes 🦠 Primary Care
🗓️ Study Start (Actual) 1 March 2024
🗓️ Primary Completion (Estimated) 15 December 2024
✅ Study Completion (Estimated) 1 March 2025
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Albuquerque, New Mexico, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 13 Years to 80 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 January 2024
  • First Submitted that Met QC Criteria 23 January 2024
  • First Posted 1 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 February 2024
  • Last Update Posted 5 February 2024
  • Last Verified February 2024