Pointing TaskSpaceInVisionNCT02885844
Effects of Inverted Vision on Pointing and Grasping in Parabolic Flight
A study testing INVERTED VISION and NORMAL VISON in people with Pointing Task and Gasping Task, run by University Hospital, Caen at 1 site in France.
Trial summary
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pointing Task, Gasping Task
- What is being tested?
- INVERTED VISION and NORMAL VISON
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Oct 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign
- Healthy volunteers (men or women)
- Aged from 21 to 65
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who have 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
- Person with medical history of oculomotor disorders
- Person with medical history of vestibular disorders
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.
Spatial orientation perception is a critical subsystem that is used by the central nervous system in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that spatial orientation is altered by the transitions in gravito-inertial force levels (Clément 2011; Clément \& Reschke 2008), transitions corresponding to mission phases particularly critical for crew safety and mission success. Accurate perception of self-in-space motion and self-motion relative to other objects is critical for successful operations that involve motor control e.g. doing an extra-vehicule activity or piloting the spacecraft. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical operations and control capabilities. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion The hypothesis is that alteration in sensorimotor performance induced by inverted vision is gravity depend: maximum alteration during hypergravity, intermediary alteration during normal gravity, minimal alteration during weightlessness.
- Conditions
- Pointing Task, Gasping Task
- Being tested
- INVERTED VISION, NORMAL VISON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVERTED VISIONProcedure or surgery
The tasks will be performed either with normal or inverted vision (upside down) using commercial off-the-shelf inverting prism goggles
NORMAL VISONProcedure or surgery
subject's field of view will be restricted by goggles without lenses in order to be equivalent to the inverted vision one.
| Study group | Role | What they receive |
|---|---|---|
| INVERTED VISION | Experimental | inverted vision (upside down) using commercial off-the-shelf inverting prism goggles Receives: Procedure: INVERTED VISION |
| NORMAL VISION | Active comparator | During normal vision trials, subject's field of view will be restricted by goggles without lenses (see below) in order to be equivalent to the inverted vision one. Receives: Procedure: NORMAL VISON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time
the time between when the target or shape appears and the subject lifts their finger off of the screen
Measured: During flight
Secondary outcomes (2)
Task duration
Only for the grasping task - the time between when the subject lifts their finger from the screen after having seen the shape, grasps the shape and touches the screen again. This will also be measured for the time between when the subject touches the screen, places the shape in the correct form fitter and touches the screen again
Measured: During flight
Accuracy
Only for the pointing task - the measured Euclidian distance from the target center to the coordinates of where the subject touched the screen.
Measured: During flight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pointing TaskStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- International Space University
- Responsible party
- Sponsor
- Investigators
- Clément GC Gilles, Study director, International Space University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885844
- Sponsor's protocol ID
- 2014-A00813-44
- Acronym
- SpaceInVision
- Status last verified
- May 2016
- First submitted
- 8 Mar 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inverted Vision on Pointing and Grasping in Parabolic Flight
- ClinicalTrials.gov ID
- NCT02885844
- Acronym / sponsor ID
- SpaceInVision / 2014-A00813-44
- Conditions
- Pointing Task, Gasping Task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- International Space University
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Sep 2016 (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.
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.
Spatial orientation perception is a critical subsystem that is used by the central nervous system in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that spatial orientation is altered by the transitions in gravito-inertial force levels (Clément 2011; Clément \& Reschke 2008), transitions corresponding to mission phases particularly critical for crew safety and mission success. Accurate perception of self-in-space motion and self-motion relative to other objects is critical for successful operations that involve motor control e.g. doing an extra-vehicule activity or piloting the spacecraft. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical operations and control capabilities. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion The hypothesis is that alteration in sensorimotor performance induced by inverted vision is gravity depend: maximum alteration during hypergravity, intermediary alteration during normal gravity, minimal alteration during weightlessness.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INVERTED VISION | Experimental | Procedure: INVERTED VISIONinverted vision (upside down) using commercial off-the-shelf inverting prism goggles |
| NORMAL VISION | Active comparator | Procedure: NORMAL VISONDuring normal vision trials, subject's field of view will be restricted by goggles without lenses (see below) in order to be equivalent to the inverted vision one. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign
- Healthy volunteers (men or women)
- Aged from 21 to 65
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
Key exclusion criteria (4 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Person with medical history of oculomotor disorders
- Person with medical history of vestibular disorders
- 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 |
|---|---|---|
| INVERTED VISIONThe tasks will be performed either with normal or inverted vision (upside down) using commercial off-the-shelf inverting prism goggles | Procedure or surgery | INVERTED VISION |
| NORMAL VISONsubject's field of view will be restricted by goggles without lenses in order to be equivalent to the inverted vision one. | Procedure or surgery | NORMAL VISION |
Primary outcome
Response time
Time frame: During flight
the time between when the target or shape appears and the subject lifts their finger off of the screen
2 secondary outcomes
Task duration
Time frame: During flight
Accuracy
Time frame: During flight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: No
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.
Clément GC Gilles study director
International Space University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVERTED VISION and NORMAL VISON in people with Pointing Task and Gasping Task, 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 7 inclusion and 4 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 1 Sep 2016. 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?
Contact Pierre DP Denise, PhD (02.31.06.81.32 ext. +33, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (time frame: During flight). 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 1 Sep 2016.