Thigh Cuffs for Fluid Shift in Healthy Subjects

LM
BR
Overseen ByBrandon R Macias, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: National Aeronautics and Space Administration (NASA)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests thigh cuffs to manage fluid shifts in astronauts during space missions. These Venoconstrictive Thigh Cuffs (VTC) aim to counteract fluid movement toward the head in weightlessness, potentially preventing eye issues known as SANS. Participants will experience different stages of wearing the cuffs before and during their flight. The trial suits astronauts on missions lasting two months or more, who do not have certain allergies or a high risk of blood clots. As an unphased trial, it offers astronauts a unique opportunity to contribute to innovative solutions for space health challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using ethinyl estradiol Combined Oral Contraceptive (COC) pills, you cannot participate.

What prior data suggests that these Venoconstrictive Thigh Cuffs are safe for use in healthy subjects?

Research has shown that special thigh cuffs can help control fluid movement in the body during situations like space travel or long periods of bed rest. Studies suggest these cuffs do not pose significant medical risks. For example, one study found no major side effects when participants used these thigh cuffs to manage fluid movement.

The cuffs work by gently squeezing the thighs, aiding in fluid control throughout the body. They have been tested in conditions similar to space without causing harm. Overall, evidence suggests these thigh cuffs are safe to use, with no serious side effects reported in these studies.12345

Why are researchers excited about this trial?

Researchers are excited about using Venoconstrictive Thigh Cuffs (VTC) because they offer a novel approach to managing fluid shifts in the body, especially in unique environments like space. Unlike traditional methods that may rely on medications to manage fluid distribution, VTCs are a non-invasive, mechanical solution that can be worn to directly influence blood flow. This technique could potentially provide an immediate and adjustable way to counteract fluid shifts, which is particularly advantageous for astronauts experiencing prolonged periods in microgravity. The ability to study these effects in-flight offers a real-time understanding of the cuff's impact, making it a promising tool for space travel and possibly other applications on Earth.

What evidence suggests that the Venoconstrictive Thigh Cuff is effective for reversing headward fluid shift?

Studies have shown that Venoconstrictive Thigh Cuffs (VTC) can help reduce the upward movement of body fluids that occurs in weightlessness, such as in space. This fluid movement can increase pressure in the head and eyes, causing problems for astronauts. Research indicates that the thigh cuffs work by gently squeezing the legs to prevent fluids from moving upward. Initial findings suggest that VTCs can reduce the swelling of the optic nerve sheath, a significant change during space travel. In this trial, participants will use VTCs to further evaluate their effectiveness in managing these fluid shifts and protecting astronauts' health in space.678910

Who Is on the Research Team?

BR

Brandon R Macias, PhD

Principal Investigator

National Aeronautics and Space Administration (NASA)

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are interested in participating in a study that involves wearing Venoconstrictive Thigh Cuffs (VTC). The cuffs are tested to see if they can counteract fluid movement towards the head in zero gravity, which could help with space-related health issues.

Inclusion Criteria

Astronauts participating in missions that are ≥2 months

Exclusion Criteria

Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
I do not have a high risk of blood clots based on tests.
I am not using birth control pills containing ethinyl estradiol.

Timeline for a Trial Participant

Preflight

Participants undergo VTC fit check and baseline data collection without and with the VTC donned

90 days before mission
2 visits (in-person)

Inflight

Participants undergo VTC fit check and data collection sessions during the mission

45 days into mission and 45 days before return
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the mission

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Venoconstrictive Thigh Cuff (VTC)
Trial Overview The effectiveness of Venoconstrictive Thigh Cuffs (VTC) is being studied. Participants will undergo two preflight sessions to check the fit and collect baseline data, then three inflight sessions including another fit check and data collection before and after wearing the VTC on specific flight days.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Flight Thigh Cuff Crew ParticipantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Aeronautics and Space Administration (NASA)

Lead Sponsor

Trials
32
Recruited
1,900+

Published Research Related to This Trial

Thigh cuffs worn by healthy volunteers during a 7-day head-down bed rest simulation effectively limited fluid shift and reduced headache symptoms, as well as minimizing plasma volume loss compared to not using the cuffs.
While thigh cuffs did not significantly improve overall orthostatic tolerance or the duration of standing tests, they did help mitigate increases in heart rate during orthostatic stress, suggesting a potential benefit in managing cardiovascular responses to fluid shifts.
Clinical effects of thigh cuffs during a 7-day 6 degrees head-down bed rest.Pavy-Le Traon, A., Maillet, A., Vasseur Clausen, P., et al.[2019]
The occlusive cuffs (Braslet) positively impacted the health of cosmonauts during the first month of their long-term missions by improving cerebral hemodynamics and reducing venous congestion, as observed in a study involving seven cosmonauts.
While the cuffs initially did not affect leg vein capacity, they led to progressive vein expansion and changes in vein properties over time, indicating potential benefits for lower extremity circulation, though the long-term safety of continuous use remains uncertain.
[Effect of prophylactic device "Braslet" on hemodynamic changes during long-term missions to orbital station Mir].Fomina, GA., Kotovskaia, AR., Temnova, EV.[2008]
Wearing venoconstrictive thigh cuffs during 7 days of head-down bed rest helped limit plasma volume loss and reduced heart rate changes, indicating some benefit in managing cardiovascular deconditioning.
Despite these benefits, thigh cuffs were not effective in preventing orthostatic intolerance, as participants still experienced similar standing times compared to the control group, suggesting that other physiological factors also play a significant role.
No effect of venoconstrictive thigh cuffs on orthostatic hypotension induced by head-down bed rest.Custaud, MA., Millet, C., Frutoso, J., et al.[2013]

Citations

DI-5-CUFFS: Venoconstrictive Thigh Cuffs Limit Body Fluid ...Thigh cuffs are effective in alleviating the symptoms associated with cephalad fluid shift in the early hours and days in space (Arbeille et al.
MITIGATING HEADWARD FLUID SHIFTS WITH VENO- ...The study uses Veno-Constrictive Thigh Cuffs (VTC) to mitigate headward fluid shifts during spaceflight, hypothesizing it will reverse or attenuate ocular and ...
Effects of Venoconstrictive Thigh Cuffs on Dry Immersion ...These findings suggest that 5 days of DI induced significant ophthalmological changes. VTC were found to dampen the ONSD enlargement induced by DI.
Venoconstrictive thigh cuffs impede fluid shifts during ...This study determined the efficacy of venoconstrictive thigh cuffs, inflated to 50 mmHg, on impeding fluid redistributions during simulated microgravity.
mitigating headward fluid shifts with veno-constrictive thigh cuffsThe purpose of this study is to evaluate the efficacy of using the NASA VTC to reverse the headward fluid shift during spaceflight and inform use of VTC as a ...
Mechanical countermeasures for spaceflight-associated neuro ...Both countermeasures, venous thigh constriction and LBNP, could pose specific medical risks. In our study, we did not observe clinically ...
Cardiac and Vascular Responses to Thigh Cuffs and ...Venoconstrictive thigh cuffs impede fluid shifts during simulated microgravity. Aviat Space Environ Med 1998 Nov;69(11):1052-8. (35) Tei C, Nishimura RA ...
Cardiac and vascular responses to thigh cuffs and ...Notwithstanding the massive fluid shift, invasive central venous pressure (CVP) measurements in spaceflight have shown it to decrease to 2 mmHg with no ...
Thigh Cuffs for Fluid Shift in Healthy SubjectsResearch shows that venoconstrictive thigh cuffs can help limit fluid shifts in the body during conditions that simulate microgravity, like space travel or bed ...
Systematic review of the effectiveness of standalone ...Thigh cuffs (aka “bracelets”) apply about 30–40 mmHg of pressure to the thighs in order to reduce venous return to the heart from the lower ...
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