Vital Sign EvaluationNCT06508047

Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

An observational study of Vital Sign Evaluation, run by Mindset Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Vital Sign Evaluation
What is being tested?: Informed Vital Core App
Type of treatment: Medical device
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 16 Jul 2024to 22 Aug 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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):

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Element Materials Techonology
Louisville, Colorado, 80027

Other trials in United States

About this study

Conditions: Vital Sign Evaluation
Being tested: Informed Vital Core App

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Informed Vital Core AppDevice
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.

Study groups in NCT06508047
Study group	Role	What they receive
Informed Vital Core App		All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App. Receives: Device: Informed Vital Core App

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory Rate Accuracy
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.
Measured: 60 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 202422 Aug 2024

First posted18 Jul 2024
Study start16 Jul 2024
Primary completion22 Aug 2024
Study completion22 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vital Sign EvaluationStudies 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06508047
Sponsor's protocol ID: PR 2024-593
Status last verified: Feb 2026
First submitted: 12 Jul 2024
Last updated: 18 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Active, not recruitingPhase 2
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Active, not recruitingObservational study
VITAL: Real-World Evaluation of Amlodipine/Valsartan.
Hypertension, Cardiovascular Diseases (CVD)
Not yet recruiting
The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study
Autism Spectrum Disorder

All Vital Sign Evaluation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
ClinicalTrials.gov ID: NCT06508047
Acronym / sponsor ID: PR 2024-593
Conditions: Vital Sign Evaluation
Study type: Observational
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Mindset MedicalIndustry (pharma, biotech, devices)
Study start: 16 Jul 2024 (actual)
Primary completion: 22 Aug 2024 (actual)
Study completion: 22 Aug 2024 (actual)
First posted: 18 Jul 2024 (actual)
Results: Posted 18 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Informed Vital Core App	–	Device: Informed Vital Core AppAll subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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):

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Informed Vital Core AppInformed 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.	Device	Informed Vital Core App

Primary outcome

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.

Results and safety

Results posted to the registry on 18 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Informed Vital Core App	68	65

Primary outcome: Respiratory Rate Accuracy

Time frame: 60 seconds. Least squares mean (95% Confidence Interval). Unit: breaths per minute

Measure	Informed Vital Core App n = 65
Value	0.91 (-1.76 to 1.82)

Adverse events

Time frame: One day, inclusive of the period of respiratory measurement.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Informed Vital Core App	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vital Sign Evaluation

Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Active, not recruitingPhase 2
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Diffuse Cutaneous Systemic Sclerosis
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Active, not recruitingObservational study
VITAL: Real-World Evaluation of Amlodipine/Valsartan.
Hypertension, Cardiovascular Diseases (CVD)
Not yet recruiting
The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study
Autism Spectrum Disorder

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.

Monica Rabanal principal investigator

Element Materials Technology

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 Vital Sign Evaluation, run by Mindset Medical 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 4 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: finished, as of the sponsor's last update on 18 Mar 2026. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Rate Accuracy (time frame: 60 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06508047.

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 18 Mar 2026.