Human Research Program Flight Thigh Cuff

NCT06476106 | Enrolling By Invitation

• 1 other identifier: STUDY00000453
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Internal Jugular Vein (IJV) area

  Measured using Ultrasound.

  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.

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

• Intraocular Pressure (IOP)

  Measured using the Pneumatonometer.

  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.

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

Study Arms (1)

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.

Device: Venoconstrictive Thigh Cuff (VTC)

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.

Also known as: Thigh Cuff

Flight Thigh Cuff Crew Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Astronauts participating in missions that are ≥2 months

You may not qualify if:

• 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

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead

Study Sites (1)

Johnson Space Center, National Aeronautics and Space Administration

Houston, Texas, 77058, United States

Location

Study Officials

• Brandon R Macias, PhD

  National Aeronautics and Space Administration (NASA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: June 26, 2024
• Study Start: March 24, 2023
• Primary Completion (Estimated): May 14, 2028
• Study Completion (Estimated): May 14, 2030
• Last Updated: April 1, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)