Comparison of Non-Invasive Respiratory Monitoring System (RMS)

March 23, 2026 updated by: Michael Chu

Makani Science Respiration Monitoring System Pivotal Clinical Study Protocol

The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (manual counting) in healthy human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.

Participants will be asked to breath normally and according to a number of different procedure while wearing both monitors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Between age of 22-99
  2. BMI between 15 and 35 kg/m^2

Exclusion Criteria:

  1. Medical history of serious cardiac or pulmonary diseases/conditions.
  2. History of serious skin irritation caused by medical adhesives (tape).
  3. Cannot lay still on your back for one (1) hour.
  4. Pregnancy.
  5. Unable to give written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Device Arm
Device: Makani Science Respiratory Monitoring System
Non-invasive Respiratory Monitoring System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject was in the supine position. For each paired measurement, the percent difference is calculated. The root mean square percent error (RMSE) is then calculated across all paired supine measurements for all subjects. The RMSE is calculated by taking the square root of the average of the squared percent differences between each measured value from the respiratory monitroing system and its corresponding reference value from the manual counting.The 95% confidence intervals is calculated for the RMSE.
2 hours
Respiratory Rate Accuracy Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent difference is calculated. The root mean square percent error (RMSE) is then calculated across all paired recline measurements for all subjects. The RMSE is calculated by taking the square root of the average of the squared percent differences between each measured value from the respiratory monitroing system and its corresponding reference value from the manual counting.The 95% confidence intervals is calculated for the RMSE.
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the supine position. For each paired measurement, the percent bias is calculated across all paired supine measurements for all subjects. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. The 95% confidence intervals is calculated for the bias.
2 hours
Respiratory Rate Bias Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent bias is calculated across all paired recline measurements for all subjects. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. The 95% confidence intervals is calculated for the bias.
2 hours
Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Supine Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the supine position. For each paired measurement, the percent precision is calculated across all paired supine measurements for all subjects. Precision can be interpreted as the standard deviation of the relative paired differences. The 95% confidence intervals is calculated for the precision.
2 hours
Respiratory Rate Precision Between the Respiratory Monitoring System and Manual Counting by a Trained Professional for the Recline Position
Time Frame: 2 hours
Respiratory rate is measured concurrently by the respiratory monitoring system and by manual counting performed by a trained professional while the subject is in the recline position. For each paired measurement, the percent precision is calculated across all paired recline measurements for all subjects. Precision can be interpreted as the standard deviation of the relative paired differences. The 95% confidence intervals is calculated for the precision.
2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Supine Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The root mean square percent error (RMSPE) will be calculated separately for each BMI category, and a randomization test will be used to assess whether RMSPE differs between the two BMI groups. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI.
2 hours
Subgroup Analysis Results of Respiration Rate Accuracy by BMI for Recline Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The root mean square percent error (RMSPE) will be calculated separately for each BMI category, and a randomization test will be used to assess whether RMSPE differs between the two BMI groups. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI.
2 hours
Subgroup Analysis Results of Respiration Rate Bias by BMI for Supine Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The bias will be calculated separately for each BMI category. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
2 hours
Subgroup Analysis Results of Respiration Rate Bias by BMI for Recline Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The bias will be calculated separately for each BMI category. Bias can be interpreted as the geometric mean of the paired relative differences between Makani RMS and manual counting. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
2 hours
Subgroup Analysis Results of Respiration Rate Precision by BMI for Supine Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the supine position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The precision will be calculated separately for each BMI category. Precision can be interpreted as the standard deviation of the relative paired differences. A total of 23 participants has measurements in the supine position; 16 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
2 hours
Subgroup Analysis Results of Respiration Rate Precision by BMI for Recline Position
Time Frame: 2 hours
Respiratory rate measurements obtained in the recline position (from the primary outcome) will be stratified by subject BMI category (normal: BMI < 25; overweight: BMI ≥ 25). The precision will be calculated separately for each BMI category. Precision can be interpreted as the standard deviation of the relative paired differences. A total of 25 participants has measurements in the recline position; 18 of the participants had normal BMI and 7 of the participants had overweight BMI. No statistical test was performed here.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michael Chu

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAKANI-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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