Otitis Media With Effusion (OME)NCT06967506
Evaluation of Blowing Exercises Utilizing a Breathing Exercise Device in Otitis Media With Effusion
A study testing Blowing exercise group in people with Otitis Media With Effusion (OME) and Otitis Media With Effusion in Children, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Otitis Media With Effusion (OME), Otitis Media With Effusion in Children, Breathing Exercise
- What is being tested?
- Blowing exercise group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uşak University Faculty of Medicine
Uşak, Merkez, 64100
About this study
Official title: 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
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.
Read the 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 infection. OME can cause conductive hearing loss, aural fullness, discomfort, and, in prolonged cases, delay in speech and language development. Many children improve with spontaneous resolution or standard medical therapy. However, some children develop chronic OME and may require surgical intervention such as tympanostomy tube insertion.
The main underlying mechanism in OME is Eustachian tube dysfunction. The Eustachian tube is responsible for pressure equalization and aeration of the middle ear. It opens physiologically during swallowing, yawning, and forceful nasal maneuvers. When Eustachian tube opening is insufficient, negative pressure develops in the middle ear and fluid may accumulate. Conservative management often includes behavioral or pressure-based exercises. These exercises include the Valsalva maneuver, balloon-blowing techniques, swallowing exercises, and chewing gum. The purpose of these maneuvers is to generate positive pressure in the nasopharynx. This positive pressure can facilitate Eustachian tube opening, improve middle ear ventilation, and help resolve effusion.
The AirOFit PRO™ (AirOFit, Copenhagen, Denmark) is a respiratory training device. It is designed to improve inhalation and exhalation performance by providing resistance-based breathing exercises. The device has mainly been used in sports and pulmonary rehabilitation contexts. There are no published clinical studies that investigate the effect of AirOFit PRO™ in children with OME. Since OME is closely related to impaired middle ear aeration, a device that delivers structured and measurable positive-pressure breathing exercises may have therapeutic potential in this population.
This randomized prospective controlled trial will evaluate the effectiveness of blowing exercises performed with the AirOFit PRO™ device in children aged 4 to 10 years with documented OME. Participants will be randomized into two groups. The intervention group will perform structured blowing exercises with AirOFit PRO™ in addition to routine OME management. The control group will receive routine OME treatment without any additional breathing or blowing exercises.
In the intervention group, inspiratory and expiratory resistance settings will first be adjusted using the device's own calibration procedure. Maximal inspiratory and expiratory efforts will be measured, and these values will guide the training settings. Participants will be instructed to perform maximum-effort expiratory exercises with the device at least twice daily and preferably three times daily. Sessions will be organized in the morning, at midday, and in the evening when feasible. Each session will last a minimum of five minutes. Efforts will be separated by standardized rest intervals of approximately 30 seconds between attempts.
The main objective of this study is to determine whether device-guided blowing exercises with AirOFit PRO™ shorten the time to resolution of OME compared with routine management alone. A positive result would support the use of this non-invasive, home-based intervention as an adjunctive treatment in children with OME. It could help reduce disease duration, lower the need for surgical procedures, and improve hearing-related quality of life in this age group. The findings may also contribute to future clinical practice guidelines on the conservative management of pediatric OME.
- Conditions
- Otitis Media With Effusion (OME), Otitis Media With Effusion in Children, Breathing Exercise
- Being tested
- Blowing exercise group
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blowing exercise groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Blowing exercise group |
| Control group | No intervention | In this group, no blowing exercises will be performed apart from the routine OME treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Participants will be followed weekly for up to 3 months after enrollment, or until resolution criteria are met, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Sep 2024
- Primary completion12 Dec 2025
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With Effusion (OME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967506
- Sponsor's protocol ID
- 44944914-2024
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing personal data must comply with the data protection principles in Turkey.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06967506
- Acronym / sponsor ID
- 44944914-2024
- Conditions
- Otitis Media With Effusion (OME), Otitis Media With Effusion in Children, Breathing Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 infection. OME can cause conductive hearing loss, aural fullness, discomfort, and, in prolonged cases, delay in speech and language development. Many children improve with spontaneous resolution or standard medical therapy. However, some children develop chronic OME and may require surgical intervention such as tympanostomy tube insertion.
The main underlying mechanism in OME is Eustachian tube dysfunction. The Eustachian tube is responsible for pressure equalization and aeration of the middle ear. It opens physiologically during swallowing, yawning, and forceful nasal maneuvers. When Eustachian tube opening is insufficient, negative pressure develops in the middle ear and fluid may accumulate. Conservative management often includes behavioral or pressure-based exercises. These exercises include the Valsalva maneuver, balloon-blowing techniques, swallowing exercises, and chewing gum. The purpose of these maneuvers is to generate positive pressure in the nasopharynx. This positive pressure can facilitate Eustachian tube opening, improve middle ear ventilation, and help resolve effusion.
The AirOFit PRO™ (AirOFit, Copenhagen, Denmark) is a respiratory training device. It is designed to improve inhalation and exhalation performance by providing resistance-based breathing exercises. The device has mainly been used in sports and pulmonary rehabilitation contexts. There are no published clinical studies that investigate the effect of AirOFit PRO™ in children with OME. Since OME is closely related to impaired middle ear aeration, a device that delivers structured and measurable positive-pressure breathing exercises may have therapeutic potential in this population.
This randomized prospective controlled trial will evaluate the effectiveness of blowing exercises performed with the AirOFit PRO™ device in children aged 4 to 10 years with documented OME. Participants will be randomized into two groups. The intervention group will perform structured blowing exercises with AirOFit PRO™ in addition to routine OME management. The control group will receive routine OME treatment without any additional breathing or blowing exercises.
In the intervention group, inspiratory and expiratory resistance settings will first be adjusted using the device's own calibration procedure. Maximal inspiratory and expiratory efforts will be measured, and these values will guide the training settings. Participants will be instructed to perform maximum-effort expiratory exercises with the device at least twice daily and preferably three times daily. Sessions will be organized in the morning, at midday, and in the evening when feasible. Each session will last a minimum of five minutes. Efforts will be separated by standardized rest intervals of approximately 30 seconds between attempts.
The main objective of this study is to determine whether device-guided blowing exercises with AirOFit PRO™ shorten the time to resolution of OME compared with routine management alone. A positive result would support the use of this non-invasive, home-based intervention as an adjunctive treatment in children with OME. It could help reduce disease duration, lower the need for surgical procedures, and improve hearing-related quality of life in this age group. The findings may also contribute to future clinical practice guidelines on the conservative management of pediatric OME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group with OME performing breathing exercises | Experimental | Device: Blowing exercise groupThe 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). |
| Control group | No intervention | –In this group, no blowing exercises will be performed apart from the routine OME treatment. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blowing exercise groupMaximum 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. | Device | The group with OME performing breathing exercises |
Primary outcome
Resolution of Tympanic Membrane Appearance and Normalization of Tympanometric Values
Time frame: Participants will be followed weekly for up to 3 months after enrollment, or until resolution criteria are met, whichever occurs first.
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)].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. Sharing personal data must comply with the data protection principles in Turkey.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blowing exercise group in people with Otitis Media With Effusion (OME) and Otitis Media With Effusion in Children, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Tympanic Membrane Appearance and Normalization of Tympanometric Values (time frame: Participants will be followed weekly for up to 3 months after enrollment, or until resolution criteria are met, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.