Human Research Program Flight Thigh Cuff

Part of paid clinical trials in Houston, Texas.

Sponsor
National Aeronautics and Space Administration (NASA)
Study ID
NCT06476106
Status
Enrolling By Invitation

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Venoconstrictive Thigh Cuff (VTC) — DEVICE
    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 Details

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Sep 2024
Primary completion
May 14, 2028
Completion
May 14, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Flight Thigh Cuff Crew Participants
    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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johnson Space Center, National Aeronautics and Space AdministrationHoustonTexas77058-

Find similar trials in Houston, TX

By research site
Johnson Space Center, National Aeronautics and Space Administration· Houston, TX

Related Studies