Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent

Part of paid clinical trials in Houston, Texas.

Sponsor
National Aeronautics and Space Administration (NASA)
Study ID
NCT06467825
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
25 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Potassium Supplement — DRUG
    Participants will be given a potassium supplement that will help prevent low blood potassium levels.
  • Furosemide 20 MG — DRUG
    Furosemide (Lasix, 20 mg) will be administered through IV catheter to induce urination. The goal of this procedure is to reduce the volume of plasma in the blood.
  • Compression Garment — DEVICE
    From the torso and leg measurements obtained during Visit 1A, a custom-designed compression garment will be constructed.

Study Details

The purpose of Lunar OI (Orthostatic Intolerance) is to determine if there are differences between males and females in tolerance to and cardiovascular responses during different angles of head-up tilt simulating gravity levels less than or equal to Earth's gravity. Also, this study will determine if a gradient compression garment affects tolerance to tilting and the cardiovascular stress at different tilt angles. Males and females are being identified by biological sex. This will be a two-phased study design. In Phase I we will determine whether there are differences in the development of signs or symptoms of orthostatic intolerance between males and females when tilted head up on a table to different angles to simulate gravity levels that astronauts may experience when landing on or launching from the surface of the Moon. In Phase II, the tilt tests simulating the same gravity levels from Phase I will be repeated, but a custom-made lower-body compression garment will be worn to see if wearing the garment affects the development of orthostatic intolerance. For both study phases, before tilting, a drug will be administered to reduce the amount fluid in the blood (plasma) to levels similar to that experienced by astronauts during spaceflight.

Key Dates

Start date
Aug 9, 2022
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
  • Experimental: Hypovolemic
    Furosemide and potassium supplement.
  • Experimental: Hypovolemic plus garment
    Furosemide and potassium supplement plus OIG.

Primary Outcome Measure

Plasma Volume [ Time Frame: 7-8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NASAHoustonTexas77058
Jason R. Lytle, PhD
[email protected]
805-407-5038
Lucinda M. Yu, MS
[email protected]

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By research site
NASA· Houston, TX

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