Healthy VolunteersARGuideNCT03298139
THE INFLUENCE OF GRAVITY
A study testing 3 levels of gravity (1G, 1.8G, 0G). in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness. Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 3 levels of gravity (1G, 1.8G, 0G).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2016to 31 Dec 2019
- 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 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (men or women)
- Aged from 18 to 67
- 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
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen
Pierre Denise, pierre.denise@unicaen.fr
About this study
Official title: THE INFLUENCE OF GRAVITY ON TARGET CUEING DURING VISUAL SEARCH USING AUGMENTED REALITY
Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness.
Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact that exocentric target cueing induces less head movements and called for least attentional and physiological workload could be the key factors for a more efficient task localization process. Moreover, weightlessness can induce spatial disorientation, which can be additionally influenced by the intrinsic and extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer \& Mittelstädt, 1997, 1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the workload will be the key factor and thus we hypothesize that an exocentric target cueing will outperform egocentric target cueing.
To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO, ED) contributes most to an efficient visual search, performance to a visuomotor task will be evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides analyzing the pointing performance, different workload indices will be additionally assessed to evaluate the effort spent on visuomotor coordination. The attentional workload will be evaluated by the performance of a secondary task (visual reaction-time task), which needs to be conducted in parallel to the visuomotor task. Furthermore, the workload will be also assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the heart rate variability (HRV).
- Conditions
- Healthy Volunteers
- Being tested
- 3 levels of gravity (1G, 1.8G, 0G).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 levels of gravity (1G, 1.8G, 0G).Other
healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G).
| Study group | Role | What they receive |
|---|---|---|
| parabolic flights | Experimental | parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). Receives: Other: 3 levels of gravity (1G, 1.8G, 0G). |
What is being measured
The primary outcome is the main question the study is designed to answer.
visuomotor performance
The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements.
Measured: baseline
common external display guidance method (ED)
common external display guidance method (ED) and exocentric "in-view" cueing (EXO), using common guidance method with an external display (ED) as a control condition
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Oct 2016
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (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.
- 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
- 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
- NCT03298139
- Sponsor's protocol ID
- 16-115
- Acronym
- ARGuide
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE INFLUENCE OF GRAVITY ON TARGET CUEING DURING VISUAL SEARCH USING AUGMENTED REALITY
- ClinicalTrials.gov ID
- NCT03298139
- Acronym / sponsor ID
- ARGuide / 16-115
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Oct 2017 (actual)
- 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.
Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness.
Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact that exocentric target cueing induces less head movements and called for least attentional and physiological workload could be the key factors for a more efficient task localization process. Moreover, weightlessness can induce spatial disorientation, which can be additionally influenced by the intrinsic and extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer \& Mittelstädt, 1997, 1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the workload will be the key factor and thus we hypothesize that an exocentric target cueing will outperform egocentric target cueing.
To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO, ED) contributes most to an efficient visual search, performance to a visuomotor task will be evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides analyzing the pointing performance, different workload indices will be additionally assessed to evaluate the effort spent on visuomotor coordination. The attentional workload will be evaluated by the performance of a secondary task (visual reaction-time task), which needs to be conducted in parallel to the visuomotor task. Furthermore, the workload will be also assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the heart rate variability (HRV).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parabolic flights | Experimental | Other: 3 levels of gravity (1G, 1.8G, 0G).parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers (men or women)
- Aged from 18 to 67
- 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 (2 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- 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 |
|---|---|---|
| 3 levels of gravity (1G, 1.8G, 0G).healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G). | Other | parabolic flights |
Primary outcome
visuomotor performance
Time frame: baseline
The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements.
common external display guidance method (ED)
Time frame: baseline
common external display guidance method (ED) and exocentric "in-view" cueing (EXO), using common guidance method with an external display (ED) as a control condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 levels of gravity (1G, 1.8G, 0G). 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 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. 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 Denise, MD-PhD (+33 231.06.81.32, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visuomotor performance (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 2 Oct 2017.