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

NCT04418973 | Completed

• 1 other identifier: 2019_0074
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Volatolom; Volatile organic compounds (VOCs); dyspnea; electronic nose; mass spectrometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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 intensity of the sensory components of the dyspnea and the variation of VOC profiles.

  at the only one study visit: around 2 hours

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

  at the only one study visit: around 2 hours

Study Arms (2)

A - load/apnea

EXPERIMENTAL

Threshold inspiratory load then apnea

Other: VOCs analysis in exhaled air

B- apnea/load

EXPERIMENTAL

apnea than threshold inspiratory load

Other: VOCs analysis in exhaled air

Interventions

VOCs analysis in exhaled air OTHER

using an electronic nose and a mass spectrometry

A - load/apnea; B- apnea/load

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch hospital

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Devillier

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: June 5, 2020
• Study Start: September 7, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)