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

Primary Purpose

Healthy Subjects

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VOCs analysis in exhaled air
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Subjects focused on measuring Volatolom, Volatile organic compounds (VOCs), dyspnea, electronic nose, mass spectrometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Foch hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A - load/apnea

B- apnea/load

Arm Description

Threshold inspiratory load then apnea

apnea than threshold inspiratory load

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).

Full Information

First Posted
February 12, 2020
Last Updated
October 21, 2020
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT04418973
Brief Title
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
Volatolom, Volatile organic compounds (VOCs), dyspnea, electronic nose, mass spectrometry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - load/apnea
Arm Type
Experimental
Arm Description
Threshold inspiratory load then apnea
Arm Title
B- apnea/load
Arm Type
Experimental
Arm Description
apnea than threshold inspiratory load
Intervention Type
Other
Intervention Name(s)
VOCs analysis in exhaled air
Intervention Description
using an electronic nose and a mass spectrometry
Primary Outcome Measure Information:
Title
Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.
Description
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.
Time Frame
at the only one study visit: around 2 hours
Secondary Outcome Measure Information:
Title
Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.
Description
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).
Time Frame
at the only one study visit: around 2 hours
Title
Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.
Description
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).
Time Frame
at the only one study visit: around 2 hours
Title
Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.
Description
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).
Time Frame
at the only one study visit: around 2 hours
Title
Comparison of VOC profiles in exhaled air according to smoking status.
Description
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).
Time Frame
at the only one study visit: around 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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