Respiratory MonitoringNCT06521385
Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
A study testing Makani Science Respiratory Monitoring System in people with Respiratory Monitoring, run by Makani Science at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards. Read more about this study
- Who is it for?
- Ages 22 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Monitoring
- What is being tested?
- Makani Science Respiratory Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 2 Jul 2024
- Phase
- Interventional
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between age of 22-99
- BMI between 15 and 40 kg/m^2
Who cannot join
- Medical history of serious symptomatic, cardiac, or pulmonary disease.
- History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
- Cannot lay still for one (1) hour.
- Cannot give written informed consent.
- Unable to follow instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illumination Foundation
Fullerton, California, 92833
About this study
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.
- Conditions
- Respiratory Monitoring
- Being tested
- Makani Science Respiratory Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Makani Science Respiratory Monitoring SystemDevice
Subjects monitored by the Makani Science Respiratory Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | Subjects with both the reference and experimental device placed for paired data collection Receives: Device: Makani Science Respiratory Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate Accuracy Compared Between Experimental and Reference Devices
Mean absolute error (MAE) was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). MAE was defined as the average of the absolute differences between the experimental and reference measurements. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE. Device performance was considered acceptable if the MAE was within 3 breaths per minute (BPM) of the reference device.
Measured: 1 hour
Secondary outcomes (5)
Respiratory Rate Bias Compared Between Experimental and Reference Devices
Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). Bias was defined as the average of the differences between the experimental and reference measurements. A negative bias indicates the experimental device underreports the measurement. The lower and upper bounds of the 95% confidence interval were also calculated for each biase.
Measured: 1 hour
Makani Science System Performance After Simulated Breathing Artifacts
Mean absolute error (MAE) and Bias was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after subject performed simulated breathing artifacts. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and Bias.
Measured: 15 minutes
Makani Science System Performance With Subject Laying on the Right Side
Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their right side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase.
Measured: 15 minutes
Makani Science System Performance With Subject Laying on the Left Side
Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to their left side. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase.
Measured: 15 minutes
Makani Science System Performance With Subject Laying in the Reclined Position
Mean absolute error (MAE) and biase was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device) after the subject shifted to the reclined position. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE and biase.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start17 May 2024
- Primary completion2 Jul 2024
- Study completion2 Jul 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 Respiratory MonitoringStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makani Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521385
- Sponsor's protocol ID
- Makani-004
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2024
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
- ClinicalTrials.gov ID
- NCT06521385
- Acronym / sponsor ID
- Makani-004
- Conditions
- Respiratory Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Makani ScienceIndustry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Makani Science Respiratory Monitoring SystemSubjects with both the reference and experimental device placed for paired data collection |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between age of 22-99
- BMI between 15 and 40 kg/m^2
Key exclusion criteria (5 listed)
- Medical history of serious symptomatic, cardiac, or pulmonary disease.
- History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
- Cannot lay still for one (1) hour.
- Cannot give written informed consent.
- Unable to follow instructions.
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 |
|---|---|---|
| Makani Science Respiratory Monitoring SystemSubjects monitored by the Makani Science Respiratory Monitoring System | Device | Device Arm |
Primary outcome
Respiratory Rate Accuracy Compared Between Experimental and Reference Devices
Time frame: 1 hour
Mean absolute error (MAE) was calculated for concurrent respiratory rate measurements obtained from the Makani Science system (experimental device) and capnography (reference device). MAE was defined as the average of the absolute differences between the experimental and reference measurements. The lower and upper bounds of the 95% confidence interval were also calculated for each MAE. Device performance was considered acceptable if the MAE was within 3 breaths per minute (BPM) of the reference device.
5 secondary outcomes
Respiratory Rate Bias Compared Between Experimental and Reference Devices
Time frame: 1 hour
Makani Science System Performance After Simulated Breathing Artifacts
Time frame: 15 minutes
Makani Science System Performance With Subject Laying on the Right Side
Time frame: 15 minutes
Makani Science System Performance With Subject Laying on the Left Side
Time frame: 15 minutes
Makani Science System Performance With Subject Laying in the Reclined Position
Time frame: 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Makani Science Respiratory Monitoring System in people with Respiratory Monitoring, run by Makani Science 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 2 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 16 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 16 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 Compared Between Experimental and Reference Devices (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.