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.
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
- Recruiting
Umr Ucbn/Inserm U1075 Comete
Caen, Basse-Normandie, 14032
Pierre Denise, MD PhD, 332068214, pierre.denise@unicaen.fr
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.
- Conditions
- Healthy Volunteers
- 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 group | Role | What they receive |
|---|---|---|
| perceived egocentric distance measurements - parabolic flight | Other | perceived 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.
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
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.
- First posted27 Jul 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 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.
- 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
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Gravity on the Perception of Egocentric Distance (Blindpulling)
- ClinicalTrials.gov ID
- NCT02508545
- Acronym / sponsor ID
- Blindpulling / 14-002
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2017 (estimated)
- First posted
- 27 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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perceived egocentric distance measurements - parabolic flight | Other | Other: perceived egocentric distance (PED) measurements, Other: Parabolic flightperceived egocentric distance (PED) measurements during parabolic flight |
Who may qualify
- Ages
- 21 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 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
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 |
|---|---|---|
| perceived egocentric distance (PED) measurements | Other | perceived egocentric distance measurements - parabolic flight |
| Parabolic flight | Other | perceived egocentric distance measurements - parabolic flight |
Primary outcome
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
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
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 27 Jul 2015.
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Screening Protocol
Pain
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 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.