Validation of a New System for Measuring Ventilation and CO₂ Production

NCT07677241 | Not Yet Recruiting

• 1 other identifier: 38RC25.0261
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Gas exchange measurement systems are complex and require specialized facilities and expertise. As a result, access to these measurements remains limited, particularly in the field of sports performance. The aim of this validation study was to compare measurements obtained with a reference device and a new portable system.

Conditions

Healhty

Keywords

exercise; ventilatory measurement

Outcome Measures

Primary Outcomes (1)

• Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.

  Equivalence of measurements within a 5% margin of error.

  During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.

Interventions

ZoneX DEVICE

The ZoneX device was developed by PAIRFS. It is a system designed to measure changes in expired volume and fluctuations in the fractional concentration of carbon dioxide in exhaled air (FeCO₂) in healthy volunteers. These data are transmitted in real time via Bluetooth Low Energy (BLE) to dedicated PC software for acquisition and analysis. The device is CE-marked, demonstrating compliance with applicable European regulatory requirements (certificate of conformity provided in the appendix).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy people from sports team

You may qualify if:

• Male or female adults (aged ≥ 18 years).
• Individuals affiliated with, or benefiting from, a health insurance or social security scheme.
• Individuals capable of understanding and signing an informed consent form.
• Individuals fluent in French.

You may not qualify if:

• Current tobacco smoking.
• Any cardiovascular, respiratory, or musculoskeletal condition that could impair the ability to perform a maximal exercise test.
• Individuals unwilling or unable to provide written informed consent.
• Individuals with hierarchical, family, or close personal relationships with the principal investigator.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• stephane DOUTRELEAU, MD, PhD

  University Grenoble Alps

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephane L DOUTRELEAU, MD, PhD

CONTACT

+33672511656; sdoutreleau@chu-grenoble.fr

Marie COUDURIER, MD

CONTACT

+33476765494; mcoudurier3@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 30, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

FR (1)