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NCT Number: NCT07537478

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Scientific Arden Hills

Saint Paul, Minnesota, 55014, United States

Location status: Recruiting

Location contact

Kevin Chu, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley M Jensen, Masters of Science

CONTACT

[email protected]

612-449-2918

Bin Mi, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Respiration Measured Via End-tidal CO2 and Spirometry Study

Acronym: RESPI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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