Clinical trial NCT06508047: Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Official title: Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Sign Evaluation
Lead sponsor: Mindset Medical
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 65
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 30% of the participants will be male At least 30% of the participants will be female

At least 33% of the participants will be with BMI between 25.0 to 29.9 kg/m2 (overweight) At least 33% of the participants will be with BMI \> 30.0 kg/m2 (obese)

At least 15% of participants will have a light skin tone (Fitzpatrick Scale 1 or 2) At least 15% of participants will have a medium skin tone (Fitzpatrick Scale 3 or 4) At least 15% of participants will have a dark skin tone (Fitzpatrick Scale 5 or 6)

The study will attempt to enroll a race/ethnicity distribution similar to population demographics consistent with the 2020 US Census Data

At least 5 participants will have a history of smoking

At least 10 participants with chronic conditions (self-reported):

Brief 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

Primary outcomes:
measure: Respiratory Rate Accuracy
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Element Materials Techonology
state: Colorado
Study officials:
affiliation: Element Materials Technology
name: Monica Rabanal
role: PRINCIPAL_INVESTIGATOR
References: