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Easing the squeeze: new study aims to reduce ear pain in oxygen chambers

NCT ID NCT04804098

Symptom relief Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether changing how fast pressure increases during hyperbaric oxygen therapy (HBOT) can lower the chance of ear pain and injury. Over 1,500 people receiving HBOT were randomly assigned to one of two compression schedules. The goal was to see if a non-linear (slower at first) pressure increase causes fewer treatment interruptions and less ear damage than a steady, linear increase.

What this could mean

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

Active substance
Compression schedule (linear vs. non-linear rate of pressure increase)
What this could lead to
If successful, this could lead to a more comfortable hyperbaric oxygen treatment with fewer ear-related side effects.
What could go wrong
This is a completed study, but the intervention only changes the compression rate, not the underlying therapy. Results may not apply to all patients or settings.

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

1,553 people

The number who actually took part.

Started

Oct 2021

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: \- Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen. Exclusion Criteria: * Any patient with absolute contraindications to hyperbaric oxygen treatment * Patients with chronic bilateral perforation of the tympanic membrane or; * A history of prior surgical placement of myringotomy tubes.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer disorder of ear Ear Diseases eustachian tube disorder injury middle ear disorder

As listed by the trial registrant

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

Ear barotrauma Ear diseases Eustachian tube dysfunction Middle ear barotrauma Middle ear disease Middle ear; injury Pressure injury

Contacts and locations

Locations

  • Phelps Hospital Northwell Health

    Sleepy Hollow, New York, 10591, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.