Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI) (RESPI)

May 13, 2026 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthy participants from the BSC employee population.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wearable respiration mask
Healthy control subjects not eligible for exercise.
Device: Wearable respiration Mask
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.
Wearable respiration mask - Exercise
Healthy control subjects eligible for exercise.
Device: Wearable Respiration mask - exercise
Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment through the end of the data collection visit, expected to take up to 3 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate detection - spirometry
Time Frame: From enrollment through the data collection visit, up to 3 hours.
Spirometry will be measured as Forced Vital Capacity (FVC).
From enrollment through the data collection visit, up to 3 hours.

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Kevin Chu, PhD, Boston Scientific Corporation

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C2193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to concerns about privacy and confidentiality in a small study population.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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