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MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY

MULTI-SYSTEM PHYSIOLOGIC RESPONSE TO VARYING LEVELS OF PARTIAL GRAVITY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03963856
Acronym
GRAVIDOSE
Enrollment
18
Registered
2019-05-28
Start date
2019-06-01
Completion date
2020-12-15
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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 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.

Interventions

OTHERparbolic flight

weightlessness during parabolic flight

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressurebaselinewill be assessed continuously using the Triggerfish

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026