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A puff of air could unclog stuffy ears without surgery?

NCT ID NCT07777302

Disease control Sponsor: Philip Perez 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests a device called EarFlo, which delivers a small puff of air through the nose during swallowing to help open the Eustachian tube and equalize pressure in the middle ear. It is designed for adults with Eustachian tube dysfunction or fluid buildup in the ear (otitis media with effusion). Participants use the device once during a clinic visit, and doctors check ear function before and after to see if it improves pressure and symptoms. The goal is to see if this simple, non-invasive approach can offer relief without surgery or ear tubes.

What this could mean

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

Active substance
EarFlo device, a non-invasive cup-based device that delivers a controlled puff of air through the nose during swallowing to help open the Eustachian tube and equalize middle ear pressure.
What this could lead to
If successful, this could offer a simple, drug-free, at-home option to relieve ear pressure and fluid without surgery or tubes.
What could go wrong
This is an early, single-use study, so any benefits may be short-lived and may not translate to long-term relief. The device may not work for everyone or could cause discomfort.

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 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

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

18 years and older

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: * Adults aged 18 years and older. * Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment. * Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment. * Willingness to refrain from initiating new treatments for OME/ETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed. Exclusion Criteria: * Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks. * Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance. * Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders). * Recent eye, ear or nose surgeries or ear trauma. (\<4 weeks)

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Conditions

The condition(s) this trial relates to.

eustachian tube disorder otitis media with effusion

As listed by the trial registrant

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

Eustachian tube dysfunction Otitis media with effusion Otitis media with effusion (OME)

How to take part

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

  1. The places running it

    4 sites. 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. 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

  • Eye and Ear Institute / UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Mercy

    Pittsburgh, Pennsylvania, 15219, United States

  • UPMC Montefiore

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

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