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

NCT07537478 | Not Yet Recruiting

• 1 other identifier: C2193
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.

Conditions

Respiration Rate Detection

Keywords

end tidal co2; spirometry

Outcome Measures

Primary Outcomes (1)

• Respiratory rate detection - end tidal CO2

  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 Outcomes (1)

• Respiratory rate detection - spirometry

  From enrollment through the data collection visit, up to 3 hours.

Study Arms (2)

Wearable respiration mask

Healthy control subjects not eligible for exercise.

Device: Wearable respiration Mask

Wearable respiration mask - Exercise

Healthy control subjects eligible for exercise.

Device: Wearable Respiration mask - exercise

Interventions

Wearable Respiration mask - exercise DEVICE

Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest and exercise.

Wearable respiration mask - Exercise

Wearable respiration Mask DEVICE

Participants will be fitted for the respiration mask placed on their face to measure respiration data during rest.

Wearable respiration mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants from the BSC employee population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Boston Scientific Arden Hills

Saint Paul, Minnesota, 55014, United States

Location

Study Officials

• Kevin Chu, PhD

  Boston Scientific Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley M Jensen, Masters of Science

CONTACT

612-449-2918; ashley.jensen@bsci.com

Bin Mi, PhD

CONTACT

bin.mi@bsci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 17, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)