HealhtyPAIRFSNCT07677241
Validation of a New System for Measuring Ventilation and CO₂ Production
An observational study of Healhty, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- ZoneX
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2026to 28 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people from sports team
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a New Gas Exchange Measurement System During Exercise With a Reference System
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.
Read the detailed description
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.
- Conditions
- Healhty
- Being tested
- ZoneX
- Keywords
- exercise, ventilatory measurement
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoneXDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start6 Jul 2026
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- stephane DOUTRELEAU, MD, PhD, Principal investigator, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677241
- Sponsor's protocol ID
- 38RC25.0261
- Acronym
- PAIRFS
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a New Gas Exchange Measurement System During Exercise With a Reference System
- ClinicalTrials.gov ID
- NCT07677241
- Acronym / sponsor ID
- PAIRFS / 38RC25.0261
- Conditions
- Healhty
- Keywords
- exercise, ventilatory measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people from sports team
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoneXThe 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). | Device | – |
Primary outcome
Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stephane DOUTRELEAU, MD, PhD principal investigator
University Grenoble Alps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healhty, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ventilatory flow (VE) and carbon dioxide output (VCO₂) measurements obtained using the two systems. (time frame: During the 5-minute rest period and throughout the exercise test until exhaustion. 30 minutes total.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.