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

NCT06967506 | Completed DMC

• 1 other identifier: 44944914-2024
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing Exercise; Otitis Media With Effusion (OME); Otitis Media With Effusion in Children

Outcome Measures

Primary Outcomes (1)

• Resolution of Tympanic Membrane Appearance and Normalization of Tympanometric Values

  Participants' follow-up will be concluded upon achieving both (1) normalization of tympanic membrane appearance as determined by otoscopic examination (i.e., intact, translucent, and non-retracted membrane without signs of inflammation or effusion), and (2) tympanometric values within normal limits, defined as a Type A tympanogram \[peak pressure between -100 and +50 decapascals (daPa), static acoustic compliance between 0.3 and 1.5 milliliters (mL), and external ear canal volume (ECV) within normal pediatric reference ranges for ages 4-10 years (0.3-1.0 mL)\].

  Participants will be followed weekly for up to 3 months after enrollment, or until resolution criteria are met, whichever occurs first.

Study Arms (2)

The group with OME performing breathing exercises

EXPERIMENTAL

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).

Device: Blowing exercise group

Control group

NO INTERVENTION

In this group, no blowing exercises will be performed apart from the routine OME treatment.

Interventions

Blowing exercise group DEVICE

Maximum effort exhalation exercises using the AirOFitPRO will be performed three times daily. Each session will be conducted for a minimum duration of five minutes, with 30-second intervals between each effort.

The group with OME performing breathing exercises

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University Faculty of Medicine

Uşak, Merkez, 64100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 13, 2025
• Study Start: September 25, 2024
• Primary Completion: December 12, 2025
• Study Completion: January 25, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)