HealthyNCT06476106
Human Research Program Flight Thigh Cuff
A study testing Venoconstrictive Thigh Cuff (VTC) in people with Healthy, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
Trial summary
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Venoconstrictive Thigh Cuff (VTC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 14 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Astronauts participating in missions that are ≥2 months
Who cannot join
- Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
- Use of ethinyl estradiol Combined Oral Contraceptive (COC) pills precludes participation in this study
- Having increased risk of venothromboembolism (VTE) based on preflight thrombosis/clotting related biomarkers precludes participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johnson Space Center, National Aeronautics and Space Administration
Houston, Texas, 77058
About this study
Official title: Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.
- Conditions
- Healthy
- Being tested
- Venoconstrictive Thigh Cuff (VTC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venoconstrictive Thigh Cuff (VTC)Device
Also called Thigh Cuff
The VTC is an adjustable fabric cuff that is worn on the upper thighs to retain some fluid in the legs. It consists of wide straps and a buckle which allow it to be tightened, then velcro to secure the strap in the tightened position. There is also lacing that can be tightened for micro adjustments. Imbedded within the fabric strap is a bladder that is not used for increasing tightness but allows the pressure of the cuff to be measured and tracked.
| Study group | Role | What they receive |
|---|---|---|
| Flight Thigh Cuff Crew Participants | Experimental | Participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC. Receives: Device: Venoconstrictive Thigh Cuff (VTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Jugular Vein (IJV) area
Measured using Ultrasound.
Measured: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
IJV pressure
Measured using the VeinPres device during Ultrasound.
Measured: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Intraocular Pressure (IOP)
Measured using the Pneumatonometer.
Measured: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
stroke volume
Measured from data collected during Ultrasound.
Measured: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start24 Mar 2023
- Primary completion14 May 2028 (estimated)
- Study completion14 May 2030 (estimated)
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Aeronautics and Space Administration (NASA)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brandon R Macias, PhD, Principal investigator, National Aeronautics and Space Administration (NASA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476106
- Sponsor's protocol ID
- STUDY00000453
- Status last verified
- Sep 2024
- First submitted
- 7 Mar 2024
- Last updated
- 1 Apr 2025
- Results posted
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
- ClinicalTrials.gov ID
- NCT06476106
- Acronym / sponsor ID
- STUDY00000453
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Aeronautics and Space Administration (NASA)US federal agency
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 14 May 2028 (estimated)
- Study completion
- 14 May 2030 (estimated)
- First posted
- 26 Jun 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.
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flight Thigh Cuff Crew Participants | Experimental | Device: Venoconstrictive Thigh Cuff (VTC)Participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Astronauts participating in missions that are ≥2 months
Key exclusion criteria (3 listed)
- Having known allergies to proparacaine hydrochloride ophthalmic solution precludes participation in this study
- Use of ethinyl estradiol Combined Oral Contraceptive (COC) pills precludes participation in this study
- Having increased risk of venothromboembolism (VTE) based on preflight thrombosis/clotting related biomarkers precludes participation in this study
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 |
|---|---|---|
| Venoconstrictive Thigh Cuff (VTC)Also: Thigh CuffThe VTC is an adjustable fabric cuff that is worn on the upper thighs to retain some fluid in the legs. It consists of wide straps and a buckle which allow it to be tightened, then velcro to secure the strap in the tightened position. There is also lacing that can be tightened for micro adjustments. Imbedded within the fabric strap is a bladder that is not used for increasing tightness but allows the pressure of the cuff to be measured and tracked. | Device | Flight Thigh Cuff Crew Participants |
Primary outcome
Internal Jugular Vein (IJV) area
Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using Ultrasound.
IJV pressure
Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using the VeinPres device during Ultrasound.
Intraocular Pressure (IOP)
Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured using the Pneumatonometer.
stroke volume
Time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
Measured from data collected during Ultrasound.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- 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.
Brandon R Macias, 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 Venoconstrictive Thigh Cuff (VTC) 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Internal Jugular Vein (IJV) area (time frame: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return). The study lists 4 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 1 Apr 2025.