NCT02507622

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

3.2 years

First QC Date

July 21, 2015

Last Update Submit

July 23, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas

    baseline

Study Arms (1)

gas concentration

OTHER

Gaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity.

Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose systemOther: Parabolic flight

Interventions

measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose systemOTHER
gas concentration
Parabolic flightOTHER
gas concentration

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 24, 2015

Study Start

September 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

FR(1)