By InvitationNot Applicable

Human Research Program Flight Thigh Cuff

United States10 participantsStarted 2023-03-24

Plain-language 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. 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Internal Jugular Vein (IJV) area

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

IJV pressure

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

Intraocular Pressure (IOP)

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

stroke volume

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

Trial details

NCT IDNCT06476106

SponsorNational Aeronautics and Space Administration (NASA)

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2028-05-14

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Internal Jugular Vein (IJV) area

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

IJV pressure

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

Intraocular Pressure (IOP)

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return

stroke volume

Timeframe: Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return