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

Healthy Subjects Clinical Trial

— Volatopnee  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418973
• Other study ID #: 2019_0074
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: October 2020
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Healthy Subjects

Intervention

Other:
• VOCs analysis in exhaled air
using an electronic nose and a mass spectrometry

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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