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

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Other: VOCs analysis in exhaled air

• Registration Number: NCT04418973
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Study Start: 2020-09-07
• Status Verified: 2020-10
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B- apnea/load	VOCs analysis in exhaled air	apnea than threshold inspiratory load
A - load/apnea	VOCs analysis in exhaled air	Threshold inspiratory load then apnea

Primary Outcome Measures

Name	Time	Method
Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.	at the only one study visit: around 2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.	at the only one study visit: around 2 hours	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).
Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.	at the only one study visit: around 2 hours	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).
Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.	at the only one study visit: around 2 hours	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).
Comparison of VOC profiles in exhaled air according to smoking status.	at the only one study visit: around 2 hours	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).

Trial Locations

Locations (1)

Foch hospital; 🇫🇷 Suresnes, France