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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: VOCs analysis in exhaled air

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Foch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A - load/apnea; Threshold inspiratory load then apnea	Other: VOCs analysis in exhaled air; using an electronic nose and a mass spectrometry
EXPERIMENTAL: B- apnea/load; apnea than threshold inspiratory load	Other: VOCs analysis in exhaled air; using an electronic nose and a mass spectrometry

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Philippe Devillier, Hopital Foch

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2020
• Primary Completion (ACTUAL): October 14, 2020
• Study Completion (ACTUAL): October 14, 2020

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (ACTUAL): June 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: dyspnea; mass spectrometry; Volatolom; Volatile organic compounds (VOCs); electronic nose
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: 2019_0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No