HealthyDROITDEVANTNCT02517138
Right-front Direction in Parabolic Flight
A study testing Parabolic flight and Measurements of eye movements and perception in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parabolic flight and Measurements of eye movements and perception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jan 2014
- 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 between 20-65 years
- Affiliates to a social security system
- Who are willing to take part in the study,
- Who gave written informed consent,
- Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.
Who cannot join
- People who participated in a biomedical research protocol for which the exclusion period is complete,
- pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.
- Conditions
- Healthy
- Being tested
- Parabolic flight, Measurements of eye movements and perception
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
Measurements of eye movements and perceptionOther
| Study group | Role | What they receive |
|---|---|---|
| Measurements of eye movements and perception | Other | Not described Receives: Other: Parabolic flight; Other: Measurements of eye movements and perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye movements
measurements between normal gravity and microgravity hypergravity during parabolic flight
Measured: Baseline
acceleration of the head
measurements between normal gravity and microgravity hypergravity during parabolic flight
Measured: Baseline
perception by the subjects of the right-front.
measurements between normal gravity and microgravity hypergravity during parabolic flight
Measured: Baseline
acceleration of the arms
measurements between normal gravity and microgravity hypergravity during parabolic flight
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startNov 2011
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517138
- Sponsor's protocol ID
- 11-094
- Acronym
- DROITDEVANT
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right-front Direction in Parabolic Flight
- ClinicalTrials.gov ID
- NCT02517138
- Acronym / sponsor ID
- DROITDEVANT / 11-094
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Aug 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 goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurements of eye movements and perception | Other | Other: Parabolic flight, Other: Measurements of eye movements and perception |
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 between 20-65 years
- Affiliates to a social security system
- Who are willing to take part in the study,
- Who gave written informed consent,
Key exclusion criteria (2 listed)
- People who participated in a biomedical research protocol for which the exclusion period is complete,
- 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 |
|---|---|---|
| Parabolic flight | Other | Measurements of eye movements and perception |
| Measurements of eye movements and perception | Other | Measurements of eye movements and perception |
Primary outcome
eye movements
Time frame: Baseline
measurements between normal gravity and microgravity hypergravity during parabolic flight
acceleration of the head
Time frame: Baseline
measurements between normal gravity and microgravity hypergravity during parabolic flight
perception by the subjects of the right-front.
Time frame: Baseline
measurements between normal gravity and microgravity hypergravity during parabolic flight
acceleration of the arms
Time frame: Baseline
measurements between normal gravity and microgravity hypergravity during parabolic flight
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 6 Aug 2015.
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight and Measurements of eye movements and perception in people with Healthy, 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: finished, as of the sponsor's last update on 6 Aug 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?
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?
eye movements (time frame: Baseline). The study lists 4 primary outcomes in all. 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 6 Aug 2015.