NCT07702539

Brief Summary

This study evaluates oxygen prebreathe protocols and exercise conditions to reduce risk of decompression sickness during simulated extravehicular activity. Healthy adult volunteers will undergo oxygen prebreathe followed by hypobaric chamber exposure with monitoring for symptoms and ultrasound detection of bubbles.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 30, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

June 30, 2026

Last Update Submit

July 10, 2026

Conditions

Decompression Sickness

Keywords

Decompression SicknessPrebreathe OxygenHypobaric Exposure

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Decompression Sickness

    Decompression sickness will be recorded during Extravehicular Activity (EVA) simulation at 6.2 psia following a one-hour oxygen prebreathe while resting, performing light exercise or heavier exercise.

    Up to 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants undergo oxygen prebreathe followed by hypobaric chamber exposure with exercise and monitoring.

Procedure: Oxygen Prebreathe and Hypobaric Exposure

Interventions

Oxygen Prebreathe and Hypobaric ExposurePROCEDURE

Prebreathe 100% oxygen followed by simulated spacewalk conditions in hypobaric chamber with exercise protocols.

Single Arm

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking volunteers aged 30-60 years
  • Able to meet VO2 peak requirements (\>35 ml/kg/min males, \>30 ml/kg/min females)

You may not qualify if:

  • Pregnancy
  • Lung disease, heart disease, hypertension, or diabetes
  • Musculoskeletal pain conditions
  • Requirement for regular medications such as analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Decompression Sickness

Condition Hierarchy (Ancestors)

BarotraumaWounds and Injuries

Study Officials

  • Richard Moon

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 14, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

February 27, 2027

Study Completion (Estimated)

February 27, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share