Could a breathing device help kids avoid ear tube surgery?

NCT ID NCT06967506

Symptom relief Sponsor: Uşak University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a device called AirOFit PRO, which guides children through blowing exercises, can help clear fluid behind the eardrum. Fifty-one children with otitis media with effusion (OME) used the device three times daily. The goal was to see if the exercises improve ear ventilation and reduce the need for surgery.

What this could mean

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

Active substance: AirOFit PRO breathing exercise device
What this could lead to: If it works, this device could offer a simple, non-surgical way to help children with middle ear fluid recover faster and prevent chronic problems.
What could go wrong: This is a small, completed trial with only 51 children, so results may not apply to everyone. The device may not be more effective than standard care or other exercises.

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

51 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 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

4 to 10 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: * Age between 4 and 10 years. * Presence of documented OME findings in otoscopic examination and audiological measurements. * Absence of any ear disease that could affect audiometric or tympanometric findings. * Legal guardian consent must be obtained. Exclusion Criteria: * Presence of active upper respiratory infection symptoms. * Presence of a chronic ear disease that could affect study outcomes (e.g., chronic otitis, tympanosclerosis, etc.). * Presence of diseases affecting respiratory system functions (e.g., pneumonia, pleurisy, empyema, pneumothorax, hemothorax, hydrothorax, atelectasis, pulmonary edema, pulmonary hypertension, emphysema). * Inability to perform respiratory exercises due to a general condition disturbance. * Presence of psychomotor retardation that prevents the participant from performing blowing exercises. * Refusal of the patient or their guardian to participate in the study without providing a reason.

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Conditions

The condition(s) this trial relates to.

otitis media with effusion

As listed by the trial registrant

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

Breathing exercise Otitis media with effusion (OME) Otitis media with effusion in children

Could a breathing device help kids avoid ear tube surgery?

What the study statuses mean