Breathing exercises for children with fluid in the ear
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
This study is testing if a breathing exercise device can help children aged 4 to 10 with fluid in their ears feel better and improve their hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Uşak University Academic / other |
| Locations | 1 site (Uşak, Merkez) |
| Trial ID | NCT06967506 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a breathing exercise device called AirOFit PRO™ in children aged 4 to 10 years who have otitis media with effusion (OME). OME is a condition where fluid accumulates in the middle ear, potentially leading to hearing issues. The study aims to improve ear ventilation and alleviate symptoms by utilizing pressure-based exercises that help open the Eustachian tube. Participants will be monitored for improvements in their condition through audiological assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 10 years with documented findings of OME.
Not a fit: Patients with active upper respiratory infections or chronic ear diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for children suffering from OME, potentially reducing the need for surgery.
How similar studies have performed: While similar pressure-based exercises have been used in clinical settings, the specific use of the AirOFit PRO™ device in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Uşak, Merkez
- Uşak University Faculty of Medicine — Uşak, Merkez, Turkey (Recruiting)
Study contacts
- Study coordinator: Faruk Kadri Bakkal, MD, Asistant Professor
- Email: faruk.bakkal@usak.edu.tr
- Phone: 90-5059242255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.