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NCT06967506

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

Active, enrolled NA Last updated 22 December 2025
What this trial tests

NA trial testing Blowing exercise group in Otitis Media With Effusion (OME) in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
25 September 2024
Primary endpoint
12 December 2025
25 January 2026

Quick facts

Lead sponsorUşak University
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date25 September 2024
Primary completion12 December 2025
Estimated completion25 January 2026
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Uşak University

Who can join

Adults 4 to 10, any sex, with Otitis Media With Effusion (OME) or Otitis Media With Effusion in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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