Healthy SubjectsVolatopneeNCT04418973
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
A study testing VOCs analysis in exhaled air in people with Healthy Subjects, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- VOCs analysis in exhaled air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 14 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- VOCs analysis in exhaled air
- Keywords
- Volatolom, Volatile organic compounds (VOCs), dyspnea, electronic nose, mass spectrometry
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCs analysis in exhaled airOther
using an electronic nose and a mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| A - load/apnea | Experimental | Threshold inspiratory load then apnea Receives: Other: VOCs analysis in exhaled air |
| B- apnea/load | Experimental | apnea than threshold inspiratory load Receives: Other: VOCs analysis in exhaled air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: at the only one study visit: around 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start7 Sep 2020
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Devillier, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418973
- Sponsor's protocol ID
- 2019_0074
- Acronym
- Volatopnee
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04418973
- Acronym / sponsor ID
- Volatopnee / 2019_0074
- Conditions
- Healthy Subjects
- Keywords
- Volatolom, Volatile organic compounds (VOCs), dyspnea, electronic nose, mass spectrometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - load/apnea | Experimental | Other: VOCs analysis in exhaled airThreshold inspiratory load then apnea |
| B- apnea/load | Experimental | Other: VOCs analysis in exhaled airapnea than threshold inspiratory load |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy subject
- no dyspnea
- non smoking or daily smoking more than 5 years packs
- perfect knowing of the French language
- the consent form signed
Key exclusion criteria (8 listed)
- chronic disease
- history of asthma or Chronic obstructive pulmonary disease (COPD)
- personal or family atopy
- cannabis use
- electronic cigarette
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOCs analysis in exhaled airusing an electronic nose and a mass spectrometry | Other | A - load/apnea, B- apnea/load |
Primary outcome
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.
4 secondary outcomes
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
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 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
Comparison of VOC profiles in exhaled air according to smoking status.
Time frame: at the only one study visit: around 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Devillier principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOCs analysis in exhaled air in people with Healthy Subjects, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.