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Completed

NCT Number: NCT04418973

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

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.

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Key information

Conditions

Healthy Subjects Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foch hospital

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VOCs analysis in exhaled air

Other

using an electronic nose and a mass spectrometry

Primary outcomes

  1. Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.

    Time frame: 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 outcomes

  1. Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.

    Time frame: 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).

  2. Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.

    Time frame: 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).

  3. Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.

    Time frame: 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).

  4. Comparison of VOC profiles in exhaled air according to smoking status.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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.

Acronym: Volatopnee

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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