Human Research Program Flight Thigh Cuff

National Aeronautics and Space Administration (NASA)

Status: Invitation-only

Conditions: Healthy

Treatments: Device: Venoconstrictive Thigh Cuff (VTC)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06476106

STUDY00000453

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Flight Thigh Cuff Crew Participants

Experimental group

Description:

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.

Treatment:

Device: Venoconstrictive Thigh Cuff (VTC)