Healthy VolunteersGRAVIDOSENCT03963856
MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY
A study testing parbolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
Spaceflight induces detrimental changes in most organ systems with both acute changes and chronic adaptations. For example, acute fluid shifts associated with weightlessness (also called - improperly - microgravity) cause initial rapid cardiovascular alterations, whereas the chronic changes are more reflective of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- parbolic flight
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 15 Dec 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (men or women)
- Aged from 18 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 have 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
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women (urine pregnancy test for women of childbearing potential)
Trial locations and contacts
1 site in 1 country.
About this study
Spaceflight induces detrimental changes in most organ systems with both acute changes and chronic adaptations. For example, acute fluid shifts associated with weightlessness (also called - improperly - microgravity) cause initial rapid cardiovascular alterations, whereas the chronic changes are more reflective of cardiovascular deconditioning and cerebrovascular/ocular adaptations (Pavy-Le Traon et al., 2007).
Long-duration stays in weightlessness have resulted in ocular structural and functional adaptations in some astronauts, which has been termed the Spaceflight Associated Neuro-ocular Syndrome (SANS ; see review in Lee et al., 2018). The leading hypothesis is that ocular changes are the consequence of chronic exposure to the weightlessness-induced headward (cephalad) fluid shift experienced by all astronauts. Countermeasures targeted to reverse this fluid shift, including lower body negative pressure and veno-occlusive thigh cuffs, have been proposed and tested in ground-based studies using a head-down tilt model of the cephalad fluid shift. However, the amount of fluid shift reversal required to prevent the development of SANS has not been investigated or determined. Similarly, artificial gravity through centrifugation has been proposed as a SANS countermeasure, given its ability to reverse headward fluid shifts and its efficacy as a countermeasure to long-duration bed rest-induced cardiovascular adaptations (long-duration bed rest is widely employed to simulate the effects of microgravity on various physiological systems). However, the minimum level of artificial gravity required also has not been investigated.
The primary objective of this study is to characterize cardiovascular, cerebrovascular, and ocular changes across a range of gravity levels to identify a threshold of gravitational load that can serve as a countermeasure to SANS during future spaceflight missions.
- Conditions
- Healthy Volunteers
- Being tested
- parbolic flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parbolic flightOther
weightlessness during parabolic flight
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
will be assessed continuously using the Triggerfish
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jun 2019
- Primary completion12 Jun 2020
- Study completion15 Dec 2020
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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963856
- Sponsor's protocol ID
- 18-072
- Acronym
- GRAVIDOSE
- Status last verified
- Mar 2022
- First submitted
- 23 May 2019
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY
- ClinicalTrials.gov ID
- NCT03963856
- Acronym / sponsor ID
- GRAVIDOSE / 18-072
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 28 May 2019 (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.
Spaceflight induces detrimental changes in most organ systems with both acute changes and chronic adaptations. For example, acute fluid shifts associated with weightlessness (also called - improperly - microgravity) cause initial rapid cardiovascular alterations, whereas the chronic changes are more reflective of cardiovascular deconditioning and cerebrovascular/ocular adaptations (Pavy-Le Traon et al., 2007).
Long-duration stays in weightlessness have resulted in ocular structural and functional adaptations in some astronauts, which has been termed the Spaceflight Associated Neuro-ocular Syndrome (SANS ; see review in Lee et al., 2018). The leading hypothesis is that ocular changes are the consequence of chronic exposure to the weightlessness-induced headward (cephalad) fluid shift experienced by all astronauts. Countermeasures targeted to reverse this fluid shift, including lower body negative pressure and veno-occlusive thigh cuffs, have been proposed and tested in ground-based studies using a head-down tilt model of the cephalad fluid shift. However, the amount of fluid shift reversal required to prevent the development of SANS has not been investigated or determined. Similarly, artificial gravity through centrifugation has been proposed as a SANS countermeasure, given its ability to reverse headward fluid shifts and its efficacy as a countermeasure to long-duration bed rest-induced cardiovascular adaptations (long-duration bed rest is widely employed to simulate the effects of microgravity on various physiological systems). However, the minimum level of artificial gravity required also has not been investigated.
The primary objective of this study is to characterize cardiovascular, cerebrovascular, and ocular changes across a range of gravity levels to identify a threshold of gravitational load that can serve as a countermeasure to SANS during future spaceflight missions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 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 18 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 (2 listed)
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women (urine pregnancy test for women of childbearing potential)
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 |
|---|---|---|
| parbolic flightweightlessness during parabolic flight | Other | – |
Primary outcome
Intraocular Pressure
Time frame: baseline
will be assessed continuously using the Triggerfish
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parbolic 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 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: finished, as of the sponsor's last update on 6 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: baseline). 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 6 May 2023.