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OpenTrials
Completed

NCT Number: NCT06508047

Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including respiratory rate (RR). The purpose of the study is to conduct accuracy validation when compared to a FDA-cleared/approved vital sign monitoring device (reference device).

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Element Materials Techonology

Louisville, Colorado, 80027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate.
  • Participant must be ≥22 years of age
  • Participant must be willing and able to comply with study procedures and duration
  • Participants or legally authorized representative must be able to read or write in English

Exclusion criteria

  • Participants who refuse or are unable to sign an informed written consent for study
  • Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
  • Compromised circulation, injury, or physical malformation the Region of Interest (ROI) which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
  • Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
  • Other known health condition, should be considered upon disclosure in health assessment form

Treatment and study plan

Informed Vital Core App

Device

Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.

Primary outcomes

  1. Respiratory Rate Accuracy

    Time frame: 60 seconds

    The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference (Ref) Respiratory Rate as counted using the End Tidal Carbon Dioxide scored waveform by counting the respiratory peaks per minute for all stable respiratory periods.

Sponsors and collaborators

Lead sponsor

Mindset Medical

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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