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COMPLETED
NCT06740305
PHASE1

NASA Prebreathe Study

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

This study will validate the experimental method and chamber facility at the Duke Center for Hyperbaric Medicine \& Environmental Physiology and test team capabilities to support NASA decompression sickness (DCS) studies. This project is related to development of protocols for extravehicular activity (EVA, "spacewalks") to minimize the risk of decompression sickness. Duke will perform four test days, collecting and recording data each day. Each test day will involve 3 volunteer subjects ages 18-50 years, who will breathe 100% oxygen for 6 hours. This will be followed by 6 hours in the hypobaric chamber at 1/3 atmosphere, during which subjects will perform various tasks, including arm and leg exercises, and undergo ultrasound testing to detect vascular bubbles. End-points will include bubble scores, and decompression sickness (DCS). If subjects develop DCS symptoms they will immediately be recompressed to ambient pressure and be assessed and treated.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2025-05-05

Completion Date

2025-08-21

Last Updated

2026-06-01

Healthy Volunteers

Yes

Interventions

OTHER

Altitude

Subjects will be exposed to simulated altitude (30,000 ft, 4.3 psia) in a hypobaric chamber. This is the same ambient pressure to which astronauts are exposed during EVA ("space walks").

DRUG

100% Oxygen

Oxygen pre-breathing prior to altitude or simulated high altitude exposure is routinely used by the Air Force, NASA and organizations such as Duke Medical Center to prevent and treat decompression sickness as well as for treatment of patients. Oxygen used for this study is medical grade.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States