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NASA Prebreathe Study

NCT06740305 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

  • Decompression Sickness

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.

Sponsors & Collaborators

  • National Aeronautics and Space Administration (NASA)

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Richard E Moon, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740305 on ClinicalTrials.gov