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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Uşak University Faculty of Medicine
RECRUITING
Uşak
Contact Information
Primary
Faruk Kadri Bakkal, MD, Asistant Professor
faruk.bakkal@usak.edu.tr
90-5059242255
Backup
Ali Yavuz Karahan, MD, Associate Professor
ali.karahan@usak.edu.tr
90-5386921934
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2025-11-25
Participants
Target number of participants: 50
Treatments
Experimental: The group with OME performing breathing exercises
The blowing exercises to be performed with AirOFit PRO will be carried out as follows:~1. Inhalation power will be adjusted: Using the device's own settings, inspiration will be performed with minimal effort for measurement. The participant will be asked to perform 3 maximum efforts at 30-second intervals, and the highest measured value will be recorded.~2. Exhalation power: Using the device's own settings, expiration will be performed with maximum effort for measurement. The participant will be asked to perform 3 maximum efforts at 30-second intervals, and the highest measured value will be recorded.~3. These exercises will be performed at least twice a day, preferably three times (morning/noon/evening).
No_intervention: Control group
In this group, no blowing exercises will be performed apart from the routine OME treatment.
Sponsors
Leads: Uşak University

This content was sourced from clinicaltrials.gov