Decompression SicknessNCT07702539
NASA Exercise Prebreathe Study
A study testing Oxygen Prebreathe and Hypobaric Exposure in people with Decompression Sickness, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Decompression Sickness
- What is being tested?
- Oxygen Prebreathe and Hypobaric Exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 27 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking volunteers aged 30-60 years
- Able to meet VO2 peak requirements (>35 ml/kg/min males, >30 ml/kg/min females)
Who cannot join
- Pregnancy
- Lung disease, heart disease, hypertension, or diabetes
- Musculoskeletal pain conditions
- Requirement for regular medications such as analgesics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Richard E Moon, MD, 919-684-6726, richard.moon@duke.edu
Zach Ransom, 919-684-6726, zach.ransom@duke.edu
About this study
Official title: Exercise Prebreathe Study in Healthy Adult Volunteers to Evaluate Risk of Decompression Sickness During Simulated Spacewalk Conditions
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.
- Conditions
- Decompression Sickness
- Being tested
- Oxygen Prebreathe and Hypobaric Exposure
- Keywords
- Decompression Sickness, Prebreathe Oxygen, Hypobaric Exposure
- Medical subject headings
- Decompression Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Prebreathe and Hypobaric ExposureProcedure or surgery
Prebreathe 100% oxygen followed by simulated spacewalk conditions in hypobaric chamber with exercise protocols.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Participants undergo oxygen prebreathe followed by hypobaric chamber exposure with exercise and monitoring. Receives: Procedure: Oxygen Prebreathe and Hypobaric Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start13 Aug 2026
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression SicknessStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- Richard Moon, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702539
- Sponsor's protocol ID
- Pro00120426
- Other IDs
- 80NSSC26P0252
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Prebreathe Study in Healthy Adult Volunteers to Evaluate Risk of Decompression Sickness During Simulated Spacewalk Conditions
- ClinicalTrials.gov ID
- NCT07702539
- Acronym / sponsor ID
- Pro00120426
- Conditions
- Decompression Sickness
- Keywords
- Decompression Sickness, Prebreathe Oxygen, Hypobaric Exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 27 Feb 2027 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Procedure: Oxygen Prebreathe and Hypobaric ExposureParticipants undergo oxygen prebreathe followed by hypobaric chamber exposure with exercise and monitoring. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-smoking volunteers aged 30-60 years
- Able to meet VO2 peak requirements (>35 ml/kg/min males, >30 ml/kg/min females)
Key exclusion criteria (4 listed)
- Pregnancy
- Lung disease, heart disease, hypertension, or diabetes
- Musculoskeletal pain conditions
- Requirement for regular medications such as analgesics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen Prebreathe and Hypobaric ExposurePrebreathe 100% oxygen followed by simulated spacewalk conditions in hypobaric chamber with exercise protocols. | Procedure or surgery | Single Arm |
Primary outcome
Number of participants with Decompression Sickness
Time frame: Up to 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Moon principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Prebreathe and Hypobaric Exposure in people with Decompression Sickness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Decompression Sickness (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.