Status:

ACTIVE_NOT_RECRUITING

Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With Effusion

Lead Sponsor:

Uşak University

Conditions:

Otitis Media With Effusion (OME)

Otitis Media With Effusion in Children

Eligibility:

All Genders

4-10 years

Phase:

NA

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 wit...

Detailed Description

Otitis media with effusion (OME) is one of the most common middle ear conditions in childhood. It is characterized by the presence of non-purulent fluid in the middle ear cavity without signs of acute...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 25 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 25 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06967506

Start Date

September 25 2024

End Date

January 25 2026

Last Update

December 22 2025

Active Locations (1)

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1

Uşak University Faculty of Medicine

Uşak, Merkez, Turkey (Türkiye), 64100