Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.

Study Overview
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Brief Summary
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The dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects. Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in exhaled air. The analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each VOC in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the VOC without identifying them. The aim of the study is to determine whether the analysis of VOCs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.

Official Title
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Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: VOCs analysis in exhaled air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subject no dyspnea non smoking or daily smoking more than 5 years packs perfect knowing of the French language the consent form signed affiliated to a health insurance plan Exclusion Criteria: chronic disease history of asthma or Chronic obstructive pulmonary disease (COPD) personal or family atopy cannabis use electronic cigarette medication except contraception pregnant woman without liberty or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - load/apnea<br>Threshold inspiratory load then apnea | Other: VOCs analysis in exhaled air<br>* using an electronic nose and a mass spectrometry<br>|
| Experimental: B- apnea/load<br>apnea than threshold inspiratory load | Other: VOCs analysis in exhaled air<br>* using an electronic nose and a mass spectrometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing. | Comparison of variation in VOC profiles in exhaled air of healthy subjects, over 2 types of dyspnea (inspiratory load and breath holding) relative to VOC profiles during normal rest ventilation. The VOC will be identified by their molecular mass (by the mass spectrometry) and the variations in the sensors properties of the electronic noses producing a quantitive signal change based on pattern recognition algorithms. | at the only one study visit: around 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea. | Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea (inspiratory load and breath holding).The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose). | at the only one study visit: around 2 hours | 
| Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles. | Correlation between the results of 2 questionnaires (affective multidimensional dyspnea and affective visual analogue scale) and the VOC profiles, in each of the 2 types of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose). | at the only one study visit: around 2 hours | 
| Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles. | Correlation between the results of 2 patient sensory questionnaires (sensory multidimensional dyspnea and sensory visual analogue scale) and the VOC profiles of dyspnea.The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose). | at the only one study visit: around 2 hours | 
| Comparison of VOC profiles in exhaled air according to smoking status. | Comparison of VOC profiles in exhaled air of healthy subjects, in each of the 2 types of dyspnea smokers or non smokers. The VOC will be identified by their molecular mass (by the mass spectrometry) and the sensor deflection (by an electronic nose). | at the only one study visit: around 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volatolom, Volatile organic compounds (VOCs), dyspnea, electronic nose, mass spectrometry