Respiration Rate DetectionRESPINCT07537478
Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)
An observational study of Respiration Rate Detection, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration Rate Detection
- What is being tested?
- Wearable Respiration mask - exercise and Wearable respiration Mask
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 24 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy participants from the BSC employee population.
Who may be able to join
- Willing and able to provide informed consent
- Age 18 or above
- Full time or part time BSC employee
- Willing and able to participate in the required testing
Who cannot join
- Currently enrolled in another clinical trial that might interfere with data collection or placement of the study system
- Subject is pregnant as indicated by subject report
- Known allergy or sensitivity to materials used in the study (Neoprene, Nylon)
- Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Scientific Arden Hills
Saint Paul, Minnesota, 55014
About this study
Official title: Respiration Measured Via End-tidal CO2 and Spirometry Study
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
Read the detailed description
This is a non-randomized, data collection study that will enroll up to 50 participants.
There will be one study visit per participant and no follow up period.
- Conditions
- Respiration Rate Detection
- Being tested
- Wearable Respiration mask - exercise, Wearable respiration Mask
- Keywords
- end tidal co2, spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Respiration mask - exerciseDevice
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise.
Wearable respiration MaskDevice
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.
| Study group | Role | What they receive |
|---|---|---|
| Wearable respiration mask | Healthy control subjects not eligible for exercise. Receives: Device: Wearable respiration Mask | |
| Wearable respiration mask - Exercise | Healthy control subjects eligible for exercise. Receives: Device: Wearable Respiration mask - exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate detection - end tidal CO2
End-Tidal CO2 will be measured as a fractional concentration (volume percent of CO₂ in exhaled gas).
Measured: From enrollment through the end of the data collection visit, expected to take up to 3 hours.
Secondary outcomes (1)
Respiratory rate detection - spirometry
Spirometry will be measured as Forced Vital Capacity (FVC).
Measured: From enrollment through the data collection visit, up to 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start28 May 2026
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration Rate DetectionStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Chu, PhD, Principal investigator, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537478
- Sponsor's protocol ID
- C2193
- Acronym
- RESPI
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to concerns about privacy and confidentiality in a small study population.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiration Measured Via End-tidal CO2 and Spirometry Study
- ClinicalTrials.gov ID
- NCT07537478
- Acronym / sponsor ID
- RESPI / C2193
- Conditions
- Respiration Rate Detection
- Keywords
- end tidal co2, spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
Detailed description
This is a non-randomized, data collection study that will enroll up to 50 participants.
There will be one study visit per participant and no follow up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable respiration mask | – | Device: Wearable respiration MaskHealthy control subjects not eligible for exercise. |
| Wearable respiration mask - Exercise | – | Device: Wearable Respiration mask - exerciseHealthy control subjects eligible for exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy participants from the BSC employee population.
Key inclusion criteria (4 listed)
- Willing and able to provide informed consent
- Age 18 or above
- Full time or part time BSC employee
- Willing and able to participate in the required testing
Key exclusion criteria (4 listed)
- Currently enrolled in another clinical trial that might interfere with data collection or placement of the study system
- Subject is pregnant as indicated by subject report
- Known allergy or sensitivity to materials used in the study (Neoprene, Nylon)
- Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
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 |
|---|---|---|
| Wearable Respiration mask - exerciseParticipants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise. | Device | Wearable respiration mask - Exercise |
| Wearable respiration MaskParticipants will be fitted for the respiration mask placed on their face to measure respiration data during rest. | Device | Wearable respiration mask |
Primary outcome
Respiratory rate detection - end tidal CO2
Time frame: From enrollment through the end of the data collection visit, expected to take up to 3 hours.
End-Tidal CO2 will be measured as a fractional concentration (volume percent of CO₂ in exhaled gas).
1 secondary outcome
Respiratory rate detection - spirometry
Time frame: From enrollment through the data collection visit, up to 3 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to concerns about privacy and confidentiality in a small study population.
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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.
Kevin Chu, PhD principal investigator
Boston Scientific Corporation
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 Respiration Rate Detection, run by Boston Scientific Corporation 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 4 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 14 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 detection - end tidal CO2 (time frame: From enrollment through the end of the data collection visit, expected to take up to 3 hours.). 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 14 Oct 2026.