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Could controlled Low-Oxygen breathing prevent dangerous blood pressure swings in spinal injury?

NCT ID NCT05351827

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether breathing a low-oxygen gas mixture (mild intermittent hypoxia) can help prevent blood pressure problems in people with spinal cord injuries. The 24 participants will have motor-incomplete injuries above the 12th thoracic vertebra and signs of autonomic dysfunction. Researchers will measure blood pressure changes during leg cuff inflation and position changes to see if the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mild intermittent hypoxia (breathing low-oxygen air)
What this could lead to
If it works, this could offer a simple, drug-free way to prevent dangerous blood pressure swings in people with spinal cord injuries.
What could go wrong
This is a very small, early-stage trial with only 24 participants. The approach is experimental and may not work or be safe for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae * Signs or symptoms of autonomic dysfunction (this will be determined by the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) and ISAFSCI questions. The ADFSCI requires a score of 1 on questions 16 and 22, and the International Standards to document Autonomic Function following SCI (ISAFSCI) requires a score of 1 on any parameter) * Chronic injuries (\>1 year post injury) Exclusion Criteria: * Pregnant * Smoker * Drug addiction * Complete spinal cord injury * Spinal cord injury below the 6th thoracic vertebrae * Insulin dependent diabetes * Shift workers (i.e., disrupted circadian rhythm) * Active skin breakdown or pressure sores

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John D. Dingell VA Medical Center, Detroit, MI

    RECRUITING

    Detroit, Michigan, 48201-1916, United States

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