CHUGA
Grenoble, 38000, France
Location contact
Marie COUDURIER, MD
CONTACT
Stéphane L DOUTRELEAU, MD, PhD
CONTACT
NCT Number: NCT07677241
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Grenoble, 38000, France
Marie COUDURIER, MD
CONTACT
Stéphane L DOUTRELEAU, MD, PhD
CONTACT
Exercise gas exchange measurement is the gold-standard method for assessing maximal and submaximal aerobic performance. The measured variables are essential for the objective evaluation of exercise performance.
These parameters are used to assess an individual's performance level, determine training zones, and thereby personalize training programs. Their accuracy is therefore of critical importance.
However, the assessment of ventilatory parameters is complex, as it relies on measurements of airflow (using pneumotachographs) and gas concentrations in inspired and expired air (using O₂- and CO₂-sensitive sensors). The physical properties and composition of air differ between inspiration and expiration. In particular, the saturation of expired air with water vapor-which does not behave as an ideal gas-introduces significant challenges and can reduce the reliability of current measurement systems.
The accumulation of these individual sources of measurement error ultimately determines the overall quality and accuracy of a commercial gas exchange analysis system.
Nevertheless, athletes and coaches require regular access to these measurements in order to prescribe appropriate training intensities and evaluate training effectiveness. A recent comparative study of several commercially available portable systems highlighted substantial variability in both measurement accuracy and overall performance among existing devices. Consequently, the availability of a simple, accessible, and, above all, more accurate measurement system would represent a significant advance for the sports performance community.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
Equivalence of measurements within a 5% margin of error.
Contact information is provided by the study sponsor or research team.
Marie COUDURIER, MD
CONTACT
Stephane L DOUTRELEAU, MD, PhD
CONTACT
University Hospital, Grenoble
Other
Comparison of a New Gas Exchange Measurement System During Exercise With a Reference System
Acronym: PAIRFS
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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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