HealthyAG2NCT06500338
Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels
A study testing free-fall in people with Healthy, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- free-fall
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 17 Apr 2024
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- NOVESPACE exclusion criteria includes:
- Those with certain heart and lung conditions
- dizziness
- certain inner ear conditions
- severe motor disability or impaired bone density
- psychosis
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Subjects first will be studied for baseline data collection (BDC) on Earth in a 1 gravity-level (G) environment while seated and supine. During baseline data collection, the operator will identify the proper location of the internal jugular vein measurement (below the confluence of the internal jugular vein and superior thyroid vein) using ultrasound and mark this location with a marker so subsequent scans can be taken in the same location. Thereafter, six electrocardiogram electrodes will be adhered to the skin of the chest and connected to the ultrasound machine and to a data recording system. A small blood pressure cuff will be placed around one finger; blood pressure also will be recorded continuously. The blood pressure cuff will be inflated preflight during baseline data collection and inflight during the parabolas. Baseline ultrasound images of the internal jugular vein will be acquired in the seated and supine positions on the ground. Measurements will include 2D ultrasound of the right and left internal jugular veins for measurement of cross-sectional area and pressure, and Doppler ultrasound of the right and left internal jugular veins for flow characterization.
Anti-motion sickness medication is distributed to flying participants at their discretion. Participants board the Airbus A310 aircraft fasten seatbelts for takeoff. After takeoff, the pilots fly the aircraft to a specific air zone where the parabolas will take place. With other members of the participant's group, participants will then move to the area of the cabin in which data will be collected. Participants will receive instructions from Novespace to maintain safety during the parabolic flight.
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. After that, there will be another pull-up (hypergravity) to complete the parabola. The plane then will fly in normal horizontal flight for a few minutes before repeating the parabolic flight path again. The pilots will perform this sequence of maneuvers many times. The number of times, the level of reduced gravity, and the order of reduced gravity exposures will depend upon the flight plan for that day. Subjects will be informed of the flight plan in the pre-mission briefing conducted by Novespace. 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. The total flight time from take-off to landing is approximately 2-3 hours.
During the flight, subjects will be seated in a specially designed chair with a seatbelt, and the ultrasound operator will be seated to the right and front of them facing the subject. Measurements will be taken multiple times during partial gravity or weightlessness and during level flight. Subjects are requested to minimize movements during the ultrasound measurements so that accurate measurements can be obtained. Also, subjects will be encouraged to minimize any movements during periods of increased gravity ("pull-out", "pull-up") in order to prevent motion sickness.
After the data collection is completed, subjects will be disconnected from the hardware, and electrodes can be removed. While subjects may experience fatigue, tiredness, and motion sickness from participating in parabolic flight, there will be no direct effects from the ultrasound measurements, except for perhaps skin irritation from the electrodes.
During the consent process prior to collection of video or still images, we will ask for consent as designated on the Research Consent Form. Novespace will photograph or film participants in Novespace facilities, including the aircraft, and use those images for the purposes of promotion and communication. Also, photos or video recordings of test subjects may be collected by the investigator team during the experiment. These photos may be used in future presentations or publications to demonstrate procedures used during the flight study.
- Conditions
- Healthy
- Being tested
- free-fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free-fallProcedure or surgery
Also called parabolic flight, partial gravity, weightlessness
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: free-fall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Internal jugular vein blood flow characterization
ultrasound measures of the bilateral Internal jugular vein with numeric blood flow characterization
Measured: 2-3 hours
Bilateral Internal jugular vein pressure
ultrasound measures of the bilateral Internal jugular vein using a pressure measurement device
Measured: 2-3 hours
Bilateral Internal jugular vein area
ultrasound measures of the bilateral Internal jugular vein to measure vein area
Measured: 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start21 Jul 2022
- Primary completion15 Jun 2023
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Aeronautics and Space Administration (NASA)
- Sponsor type
- US federal agency
- Collaborators
- NOVESPACE (Merignac, France), European Space Agency
- Responsible party
- Sponsor
- Investigators
- Stuart M Lee, PhD, Principal investigator, National Aeronautics and Space Administration (NASA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500338
- Sponsor's protocol ID
- STUDY00000508
- Acronym
- AG2
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Dose Response Profile of the Headward Fluid Shift During Varying Gravity Levels
- ClinicalTrials.gov ID
- NCT06500338
- Acronym / sponsor ID
- AG2 / STUDY00000508
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Aeronautics and Space Administration (NASA)US federal agency
- Collaborators
- NOVESPACE (Merignac, France), European Space Agency
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 15 Jul 2024 (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.
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.
Detailed description
Subjects first will be studied for baseline data collection (BDC) on Earth in a 1 gravity-level (G) environment while seated and supine. During baseline data collection, the operator will identify the proper location of the internal jugular vein measurement (below the confluence of the internal jugular vein and superior thyroid vein) using ultrasound and mark this location with a marker so subsequent scans can be taken in the same location. Thereafter, six electrocardiogram electrodes will be adhered to the skin of the chest and connected to the ultrasound machine and to a data recording system. A small blood pressure cuff will be placed around one finger; blood pressure also will be recorded continuously. The blood pressure cuff will be inflated preflight during baseline data collection and inflight during the parabolas. Baseline ultrasound images of the internal jugular vein will be acquired in the seated and supine positions on the ground. Measurements will include 2D ultrasound of the right and left internal jugular veins for measurement of cross-sectional area and pressure, and Doppler ultrasound of the right and left internal jugular veins for flow characterization.
Anti-motion sickness medication is distributed to flying participants at their discretion. Participants board the Airbus A310 aircraft fasten seatbelts for takeoff. After takeoff, the pilots fly the aircraft to a specific air zone where the parabolas will take place. With other members of the participant's group, participants will then move to the area of the cabin in which data will be collected. Participants will receive instructions from Novespace to maintain safety during the parabolic flight.
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. After that, there will be another pull-up (hypergravity) to complete the parabola. The plane then will fly in normal horizontal flight for a few minutes before repeating the parabolic flight path again. The pilots will perform this sequence of maneuvers many times. The number of times, the level of reduced gravity, and the order of reduced gravity exposures will depend upon the flight plan for that day. Subjects will be informed of the flight plan in the pre-mission briefing conducted by Novespace. 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. The total flight time from take-off to landing is approximately 2-3 hours.
During the flight, subjects will be seated in a specially designed chair with a seatbelt, and the ultrasound operator will be seated to the right and front of them facing the subject. Measurements will be taken multiple times during partial gravity or weightlessness and during level flight. Subjects are requested to minimize movements during the ultrasound measurements so that accurate measurements can be obtained. Also, subjects will be encouraged to minimize any movements during periods of increased gravity ("pull-out", "pull-up") in order to prevent motion sickness.
After the data collection is completed, subjects will be disconnected from the hardware, and electrodes can be removed. While subjects may experience fatigue, tiredness, and motion sickness from participating in parabolic flight, there will be no direct effects from the ultrasound measurements, except for perhaps skin irritation from the electrodes.
During the consent process prior to collection of video or still images, we will ask for consent as designated on the Research Consent Form. Novespace will photograph or film participants in Novespace facilities, including the aircraft, and use those images for the purposes of promotion and communication. Also, photos or video recordings of test subjects may be collected by the investigator team during the experiment. These photos may be used in future presentations or publications to demonstrate procedures used during the flight study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: free-fallinflight 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- NOVESPACE exclusion criteria includes:
- Those with certain heart and lung conditions
- dizziness
- certain inner ear conditions
- severe motor disability or impaired bone density
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 |
|---|---|---|
| free-fallAlso: parabolic flight, partial gravity, weightlessnessThe 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. | Procedure or surgery | inflight reduced gravity measures |
Primary outcome
Bilateral Internal jugular vein blood flow characterization
Time frame: 2-3 hours
ultrasound measures of the bilateral Internal jugular vein with numeric blood flow characterization
Bilateral Internal jugular vein pressure
Time frame: 2-3 hours
ultrasound measures of the bilateral Internal jugular vein using a pressure measurement device
Bilateral Internal jugular vein area
Time frame: 2-3 hours
ultrasound measures of the bilateral Internal jugular vein to measure vein area
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 19 Sep 2024.
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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.
Stuart M Lee, PhD principal investigator
National Aeronautics and Space Administration (NASA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free-fall in people with Healthy, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
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 3 inclusion and 16 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 19 Sep 2024. 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 United States. 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?
Bilateral Internal jugular vein blood flow characterization (time frame: 2-3 hours). The study lists 3 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 19 Sep 2024.