Healthy VolunteersE-NOSENCT02507622
E-NOSE for Breath Gas Analysis Under Microgravity Conditions
A study testing measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system and Parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system and Parabolic flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Nov 2017
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (men or women)
- Aged from 20 to 65
- Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who has given their written stated consent
- Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection
Who cannot join
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Umr Ucbn/Inserm U1075 Comete
Caen, Basse-Normandie, 14032
Pierre Denise, MD PhD, 332068214, pierre.denise@unicaen.fr
About this study
The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.
- Conditions
- Healthy Volunteers
- Being tested
- measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system, Parabolic flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose systemOther
Parabolic flightOther
| Study group | Role | What they receive |
|---|---|---|
| gas concentration | Other | Gaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity. Receives: Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system; Other: Parabolic flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507622
- Sponsor's protocol ID
- 14-103
- Acronym
- E-NOSE
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-NOSE for Breath Gas Analysis Under Microgravity Conditions
- ClinicalTrials.gov ID
- NCT02507622
- Acronym / sponsor ID
- E-NOSE / 14-103
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 24 Jul 2015 (estimated)
- 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 main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gas concentration | Other | Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system, Other: Parabolic flightGaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers (men or women)
- Aged from 20 to 65
- Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who has given their written stated consent
Key exclusion criteria (2 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
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 |
|---|---|---|
| measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system | Other | gas concentration |
| Parabolic flight | Other | gas concentration |
Primary outcome
The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system and Parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen 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 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas (time frame: baseline). 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 24 Jul 2015.