NCT06476106

Human Research Program Flight Thigh Cuff

Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: National Aeronautics and Space Administration (NASA) · Federal
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Venoconstrictive Thigh Cuff (VTC)	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.

Timeline

• Start date: 2023-03-24
• Primary completion: 2028-05-14
• Completion: 2030-05-14
• First posted: 2024-06-26
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States