drugset / Trial / NCT06467825

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

NCT06467825

Non-randomizedCrossoverOpen-labelSupportive care

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.

Timeline

Start
2022-08-09
Primary completion
2025-09
Completion
2025-09

Drugs

EvaluationDrugModalityDoseRoute
Background Furosemide Other / unclassified 20 mg Intravenous
Background Potassium Supplement Unknown 20 meq Oral

Indications

No indication recorded.