N/A
N=68
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Vital Sign Evaluation
Bottom Line
View on ClinicalTrials.gov: NCT06508047 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Respiratory Rate Accuracy — 0.91 breaths per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Informed Vital Core App (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Mindset Medical
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Rate Accuracy |
0.91 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06508047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.