Clinical trial NCT06967506: Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With Effusion
Official title: Assessment of the Blowing Exercises Using the Adjustable Personal Breathing Exercise Device AirOFit PRO™ in Children With Otitis Media With Effusion: A Randomized Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Otitis Media With Effusion (OME)
Otitis Media With Effusion in Children
Breathing Exercise
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Otitis media with effusion (OME) is a common condition in which fluid collects behind the eardrum without signs of infection. It can cause hearing problems and discomfort. Many children get better with medication, but in some cases, the condition becomes long-term and may require surgery.

OME is caused by dysfunction of the Eustachian tube, which helps balance the air pressure between the middle ear and the back of the nose (nasopharynx). Restoring proper airflow to the middle ear is important. In addition to medication, physicians often recommend pressure-based exercises such as balloon-blowing, swallowing exercises, the Valsalva maneuver, or chewing gum. These exercises help open the Eustachian tube by creating positive pressure in the nasopharynx, which can improve ear ventilation and reduce symptoms by relieving negative pressure in the middle ear.

This study will test the effect of a breathing exercise device called AirOFit PRO™ (AirOFit, Copenhagen, Denmark) in children with OME. Currently, there are no studies in the medical literature showing whether AirOFit PRO™ is effective in treating OME. If this study finds that using the AirOFit PRO™ helps children recover more quickly, it could be an important step in preventing chronic OME and reducing the need for surgery.


Eligibility criteria: 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.

Primary outcomes:
measure: Resolution of Tympanic Membrane Appearance and Normalization of Tympanometric Values
timeFrame: Participants will be followed weekly for up to 3 months after enrollment, or until resolution criteria are met, whichever occurs first.
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University Faculty of Medicine
state: Merkez
Study officials:
References: