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Healthy VolunteersBlindpullingNCT02508545

Influence of Gravity on the Perception of Egocentric Distance (Blindpulling)

A study testing perceived egocentric distance (PED) measurements and Parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Healthy Volunteers
What is being tested?
perceived egocentric distance (PED) measurements and Parabolic flight
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteFrance
Study dates
Feb 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

  • 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.

France1 site, 1 recruiting
  • Umr Ucbn/Inserm U1075 Comete

    Caen, Basse-Normandie, 14032

    Pierre Denise, MD PhD, 332068214, pierre.denise@unicaen.fr

    Recruiting

Other trials in France

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.

Cognitive function, together with good oculomotor control, eye-hand coordination, and spatial orientation perception, is a critical subsystem that is used by the CNS in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that the function of each of these subsystems is altered by the transitions in gravito-inertial force levels. These neuro-vestibular alterations, unfortunately, correspond to mission phases where physical and cognitive performance are particularly critical for crew safety and mission success. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical vehicle (or complex system) control capabilities. However, the true operational risks will be estimable only after the investigators have filled the knowledge gaps and when the investigators can accurately assess integrated performance in off-nominal operational settings.

Read more

Accurate perception of self-in-space motion and self-motion relative to other objects are critical to piloting, driving, and remote manipulator operations. 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. Despite recent, intensive training, some Shuttle landings were outside of the desired performance boundaries. Scores indicating neurovestibular dysfunction in returning astronauts generally correlated with poorer flying performances, including a lower approach and landing shorter, faster, and harder. An underestimation of distance, coupled to an overestimation of tilt magnitude or misperception of the type of motion, could be at the origin of these poorer performances.

This study should confirm that the unloading of the otoliths in weightlessness induces an alteration in the egocentric reference during space flight. Errors in egocentric localization might contribute at a higher level to the computation of misleading world-centered representations, and therefore be partly responsible for illusory sensations and motion sickness symptoms during space flight, and postural instability and oscillopsia after returning in a reduced or terrestrial gravitational force level.

Beside their fundamental implications, the results of this study have also practical implications in the design of man-machine interfaces. Changes in judgment of distance in microgravity or in reduced gravity affect crew posture and reach, display orientation, and other visual cues, which should be considered in hardware and operations design.

Being tested
perceived egocentric distance (PED) measurements, Parabolic flight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perceived egocentric distance (PED) measurementsOther

  • Parabolic flightOther

Study groups in NCT02508545
Study groupRoleWhat they receive
perceived egocentric distance measurements - parabolic flightOtherperceived egocentric distance (PED) measurements during parabolic flight
Receives: Other: perceived egocentric distance (PED) measurements; Other: Parabolic flight

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blind pulling error, i.e. difference between the actual position of the visual target and the final position of the subject between 1G, 1.8G, and 0G during parabolic flight and with blind pulling evaluation method

    Measured: baseline

  2. Blind pulling error, i.e. difference between the actual position of the visual target and the final position of the subject between 1G, 1.8G, and 0G during parabolic flight and with verbal report evaluation method

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionOct 2017 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02508545
Sponsor's protocol ID
14-002
Acronym
Blindpulling
Status last verified
Jul 2015
First submitted
21 Jul 2015
Last updated
27 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing perceived egocentric distance (PED) measurements 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 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 27 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?

Blind pulling error, i.e. difference between the actual position of the visual target and the final position of the subject between 1G, 1.8G, and 0G during parabolic flight and with blind pulling evaluation method (time frame: baseline). The study lists 2 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 27 Jul 2015.

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