Healthy VolunteersDownNCT02850380
Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?
A study testing FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch. Hypotheses are that flip switch: 1. will be biased towards visual allocentric cues when those are available; 2. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2018
- 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 from 20 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.
- Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign
Who cannot join
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Person who has already participated in a parabolic flight
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch.
Hypotheses are that flip switch:
- will be biased towards visual allocentric cues when those are available;
- will be biased towards the egocentric reference when tactile cues are added;
- will be dominated by egocentric cues when visual cues are not available;
- will be delayed and more variable when confirmatory gravitational cues are absent;
- will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
- The difference will be more pronounce when tested under Dual-task condition
- Conditions
- Healthy Volunteers
- Being tested
- FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIP SWITCHES "DOWN" IN WEIGHTLESSNESSOther
The circular instrument panel that subjects will see into the cylindrical mask consists of one switch surrounded by a luminous ring (left part of the figure below). The switch can be flipped into any direction within the full 360° range. The switch provides no visual cues about "down", but the experimenter can add such cues by means of visually polarized labelling displayed on a circular black screen at the center of the panel (right part the figure below).
| Study group | Role | What they receive |
|---|---|---|
| spatial orientation in weightlessness | Other | subjects will be asked to flip a series of switches into the "off" position. On Earth, the "off" position corresponds to "down" in all three reference frames: the visual allocentric, the non-visual allocentric as well as the egocentric frames. We expect that flip direction will be dominated by visual allocentric cues when those are available, will be delayed and more variable when confirmatory gravitational cues are absent, and will be biased towards the egocentric reference when tactile cues are added Receives: Other: FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction time of flip switch measured with a chronometer
Measured: baseline
Direction of flip switch measured with the circular instrument panel
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (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
- 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
- Collaborators
- Novespace
- Responsible party
- Sponsor
- Investigators
- Pierre DP Denise, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850380
- Sponsor's protocol ID
- 2015-A01261-48
- Acronym
- Down
- Status last verified
- Jul 2016
- First submitted
- 21 Apr 2016
- Last updated
- 1 Aug 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 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?
- ClinicalTrials.gov ID
- NCT02850380
- Acronym / sponsor ID
- Down / 2015-A01261-48
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Novespace
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Aug 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.
The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch.
Hypotheses are that flip switch:
- will be biased towards visual allocentric cues when those are available;
- will be biased towards the egocentric reference when tactile cues are added;
- will be dominated by egocentric cues when visual cues are not available;
- will be delayed and more variable when confirmatory gravitational cues are absent;
- will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
- The difference will be more pronounce when tested under Dual-task condition
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spatial orientation in weightlessness | Other | Other: FLIP SWITCHES "DOWN" IN WEIGHTLESSNESSsubjects will be asked to flip a series of switches into the "off" position. On Earth, the "off" position corresponds to "down" in all three reference frames: the visual allocentric, the non-visual allocentric as well as the egocentric frames. We expect that flip direction will be dominated by visual allocentric cues when those are available, will be delayed and more variable when confirmatory gravitational cues are absent, and will be biased towards the egocentric reference when tactile cues are added |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers (men or women)
- Aged from 20 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 (3 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Person who has already participated in a parabolic flight
- 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 |
|---|---|---|
| FLIP SWITCHES "DOWN" IN WEIGHTLESSNESSThe circular instrument panel that subjects will see into the cylindrical mask consists of one switch surrounded by a luminous ring (left part of the figure below). The switch can be flipped into any direction within the full 360° range. The switch provides no visual cues about "down", but the experimenter can add such cues by means of visually polarized labelling displayed on a circular black screen at the center of the panel (right part the figure below). | Other | spatial orientation in weightlessness |
Primary outcome
reaction time of flip switch measured with a chronometer
Time frame: baseline
Direction of flip switch measured with the circular instrument panel
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 1 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Pierre DP Denise, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS 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 7 inclusion and 3 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 Aug 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?
reaction time of flip switch measured with a chronometer (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 1 Aug 2016.