Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels

NCT06500338 | Completed

• 1 other identifier: STUDY00000508
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Parabolic flight provides a unique opportunity to evaluate the acute changes associated with varying levels of gravity and to describe how key venous parameters change at levels less than normal Earth gravity. Characterizing these changes in response to varying G-levels is an important step in determining what G-level may be required to reverse weightlessness-induced fluid shifts and thus serve as a viable countermeasure during long-duration spaceflight. Further, these results will inform National Aeronautics and Space Administration (NASA) whether there might be a lower risk of Spaceflight Associated Neuro-ocular Syndrome (SANS) and Venous Thromboembolism (VTE) during extended stays on the Moon and Mars.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Bilateral Internal jugular vein blood flow characterization

  ultrasound measures of the bilateral Internal jugular vein with numeric blood flow characterization

  2-3 hours

• Bilateral Internal jugular vein pressure

  ultrasound measures of the bilateral Internal jugular vein using a pressure measurement device

  2-3 hours

• Bilateral Internal jugular vein area

  ultrasound measures of the bilateral Internal jugular vein to measure vein area

  2-3 hours

Study Arms (3)

Preflight Seated

NO INTERVENTION

Preflight control at 1 Gravity level (G), seated. Data collection of Internal Jugular Vein (IJV) area, IJV pressure, and Doppler blood flow.

Preflight Supine

NO INTERVENTION

Preflight control at 1 Gravity level (G), supine. Data collection of Internal Jugular Vein (IJV) area, IJV pressure, and Doppler blood flow.

inflight reduced gravity measures

EXPERIMENTAL

inflight experimental at 0 Gravity levels (G), 0.25G, 0.5G, and 0.75G. Data collection of Internal Jugular Vein (IJV) area, IJV pressure, and Doppler blood flow.

Procedure: free-fall

Interventions

free-fall PROCEDURE

The aircraft will fly in parabolas that initially produce increased gravity (1.8-G, "hypergravity"), followed by \~20-50 second periods of partial gravity or weightlessness. Flights which produce partial gravity (0.25-, 0.50-, and 0.75-gravity) generally will consist of 31 parabolas (at least 10 parabolas at each gravity level), and flights that produce weightlessness generally will consist of 16 parabolas.

Also known as: parabolic flight, partial gravity, weightlessness

inflight reduced gravity measures

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In coordination with the parabolic flight company, Novespace, healthy volunteers from the population that are 25-55 years old without a history cardiovascular disease will be recruited for this study. In order to participate, subjects must be able to follow instructions in English.
• Participants must be age 18 years or older, hold a French or European Health Insurance Card, and provide medical certification of fitness for flight to NOVESPACE (i.e., NOVESPACE Parabolic Flight Medical Aptitude Certificate) completed by their medical doctor or an Authorized Medical Examiner.
• Participants must meet medical criteria and provide certification of fitness for flight to NOVESPACE (i.e. NOVESPACE Parabolic Flight Medical Aptitude Certificate) completed by their medical doctor or an Authorized Medical Examiner.

You may not qualify if:

• Those with certain heart and lung conditions
• dizziness
• certain inner ear conditions
• severe motor disability or impaired bone density
• psychosis
• mental disability prohibiting emergency evacuation
• epilepsy
• certain neurological diseases
• fear of heights/flying
• debilitating anxiety and panic attacks
• claustrophobia, women who are pregnant
• certain gastrointestinal conditions
• those taking certain medications are ineligible to participate
• An individual's overall medical fitness for flight is assessed and certified by a medical doctor or Authorized Medical Examiner.
• Pregnant women are not eligible to participate in this study.

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead
• NOVESPACE (Merignac, France): collaborator
• European Space Agency: collaborator

Study Sites (1)

NASA

Houston, Texas, 77058, United States

Location

MeSH Terms

Interventions

Weightlessness

Intervention Hierarchy (Ancestors)

Hypogravity; Gravity, Altered; Gravitation; Astronomical Phenomena; Physical Phenomena

Study Officials

• Stuart M Lee, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 21, 2022
• Primary Completion: June 15, 2023
• Study Completion: April 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Locations

US (1)