Recruiting

Observational Study

Sponsor:

National Aeronautics and Space Administration (NASA)

Code:

NCT06467825

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Potassium Supplement

Furosemide 20 MG

Compression Garment

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT06467825

Start date

Aug 9, 2022

Status verified date

Mar, 2025

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

• Pass a test subject screening facility modified Air Force Class III physical

Exclusion Criteria:

  • Known allergy to furosemide or sulfa drugs
  • Currently taking drugs or medications known to adversely interact with furosemide, including but not limited to aspirin, NSAIDs, antibiotics, or immunosuppressant drugs
  • Systemic diseases or current medications known to influence the cardiovascular system
  • Renal disease
  • Type II Diabetes
  • Pregnant participants will be excluded (a urine pregnancy screen will be made available).

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: Hypovolemic

Furosemide and potassium supplement.

experimental: Hypovolemic plus garment

Furosemide and potassium supplement plus OIG.

Interventions

Potassium Supplement

Participants will be given a potassium supplement that will help prevent low blood potassium levels.

Furosemide 20 MG

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

From the torso and leg measurements obtained during Visit 1A, a custom-designed compression garment will be constructed.

Primary outcome measure

  • Plasma Volume [ Time Frame: 7-8 hours ]
  • Tilt Tolerance Time [ Time Frame: 0-20 minutes ]
  • Heart Rate [ Time Frame: 0-20 minutes ]
  • Blood Pressure [ Time Frame: 0-20 minutes ]

Central Contacts and Locations

Central contacts

Locations

NASA

Recruiting

Houston, Texas, United States, 77058

Contacts

More Information

Sponsor

National Aeronautics and Space Administration (NASA)

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Aeronautics and Space Administration (NASA) on 2025-04-01.