Otitis Media With Effusion (OME)NCT07122999
Autoinflation as a Eustachian Tube Rehabilitation
A study testing Eustachi in people with Otitis Media With Effusion (OME) and Eustachian Tube Dysfunction, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
This randomized controlled trial evaluated the effectiveness of autoinflation in preventing recurrence of otitis media with effusion (OME) and reducing the need for reoperation after tympanostomy tube (TT) extrusion in children. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
- What is being tested?
- Eustachi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 31 Aug 2022
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 8 years
- Clinical diagnosis of chronic otitis media with effusion (OME)
- Underwent tympanostomy tube (TT) placement for persistent OME lasting more than 3 months
- Capable of performing autoinflation, as assessed by the physician
- Caregiver willing to provide informed consent and assist with at-home device use
Who cannot join
- Presence of adenoid hypertrophy or tonsillar hypertrophy
- History of craniofacial anomalies (e.g., cleft palate)
- Current otologic disease such as otorrhea or tympanic membrane perforation
- Acute otitis media or signs of active inflammation at enrollment
- Underlying severe systemic disease or immunodeficiency
- Inability or refusal to follow autoinflation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Autoinflation on the Recurrence of Otitis Media With Effusion After Tympanostomy Tube Extrusion: A Randomized Controlled Trial
This randomized controlled trial evaluated the effectiveness of autoinflation in preventing recurrence of otitis media with effusion (OME) and reducing the need for reoperation after tympanostomy tube (TT) extrusion in children. Sixty-six pediatric patients with chronic OME underwent TT placement, and 54 were included in the final analysis. After TT extrusion, participants were randomized into two groups: an autoinflation group using a handheld device (Eustachi) for five weeks, and an observation-only group. Patients were followed for two years post-extrusion, with periodic otoscopic and tympanometric assessments.
The autoinflation group showed a lower recurrence rate (19.2%) compared to the observation group (35.7%), although this difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7% vs. 28.6%). Tympanometric findings suggested more stable middle ear pressure in the autoinflation group. These results indicate that autoinflation is a safe, feasible, and non-invasive method that may support eustachian tube function and reduce the need for repeat TT placement in children following TT extrusion.
Read the detailed description
Otitis media with effusion (OME) is a prevalent pediatric condition that may lead to hearing loss and developmental delay. Tympanostomy tube (TT) placement is the standard treatment for persistent OME but does not address the underlying cause, and recurrence is common after TT extrusion. This study investigated whether autoinflation after TT extrusion could reduce OME recurrence and the need for reoperation.
In this prospective randomized controlled trial, 66 children aged 3 to 8 years with chronic OME were enrolled at a tertiary hospital. All underwent TT placement under general anesthesia and were followed bi-monthly in the outpatient clinic. After TT extrusion, 54 patients were randomized to either the autoinflation group (n = 26) or the observation group (n = 28). The autoinflation group used the Eustachi device twice daily for five weeks, with instructions provided to children and caregivers. Patients with adenoid hypertrophy, craniofacial anomalies, active otologic disease, or severe systemic disease were excluded.
Outcome measures included OME recurrence and TT reoperation rates over two years, evaluated through otoscopy and tympanometry. The recurrence rate was lower in the autoinflation group (19.2%) than in the observation group (35.7%), though the difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7%) compared to the observation group (28.6%, p = 0.048). Tympanometry results also showed stable middle ear pressure in the autoinflation group, whereas the observation group experienced a decline in type A tympanograms and an increase in type C patterns over time.
These findings suggest that autoinflation may promote functional rehabilitation of the eustachian tube and maintain middle ear ventilation after TT extrusion. The intervention was well tolerated and feasible in a home setting with caregiver supervision. While autoinflation should not replace TT placement in persistent OME, it may serve as a valuable non-invasive strategy to reduce the risk of recurrence and the need for repeat surgery. Limitations include sample size and lack of quantitative compliance data, warranting future multicenter studies for validation.
- Being tested
- Eustachi
- Keywords
- Autoinflation, Recurrence, Middle Ear Ventilation, Otitis Media with Effusion
- Medical subject headings
- Otitis Media with Effusion, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EustachiDevice
A handheld device that delivers pulsed air through the nasal passage to facilitate opening of the eustachian tube. Participants in this group use the device twice daily for 5 weeks after tympanostomy tube extrusion.
| Study group | Role | What they receive |
|---|---|---|
| Autoinflation | Experimental | Participants perform autoinflation using the Eustachi device twice daily for 5 weeks after TT extrusion. Receives: Device: Eustachi |
| Observation | No intervention | Participants are followed without autoinflation after TT extrusion (standard observation only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of otitis media with effusion (OME)
The proportion of patients with a recurrence of OME in the affected ear(s), diagnosed by otoscopy and/or tympanometry, during a 2-year follow-up period after tympanostomy tube extrusion.
Measured: Up to 24 months after tympanostomy tube extrusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2019
- Primary completion4 Oct 2019
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122999
- Sponsor's protocol ID
- 2006-016-092
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared for this study. This decision was made due to privacy considerations and the absence of a formal data-sharing plan.
Publications
Perera R, Glasziou PP, Heneghan CJ, McLellan J, Williamson I. Autoinflation for hearing loss associated with otitis media with effusion. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD006285. doi: 10.1002/14651858.CD006285.pub2.
PubMed 23728660Na HS, Lee S, Kim SH, Lee HM, Oh SJ, Lee IW, Choi SW. Autoinflation After Tympanostomy Tube Extrusion in Otitis Media With Effusion: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 May 1;152(5):472-478. doi: 10.1001/jamaoto.2026.0044.
PubMed 41817520
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Autoinflation on the Recurrence of Otitis Media With Effusion After Tympanostomy Tube Extrusion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07122999
- Acronym / sponsor ID
- 2006-016-092
- Keywords
- Autoinflation, Recurrence, Middle Ear Ventilation, Otitis Media with Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Aug 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.
This randomized controlled trial evaluated the effectiveness of autoinflation in preventing recurrence of otitis media with effusion (OME) and reducing the need for reoperation after tympanostomy tube (TT) extrusion in children. Sixty-six pediatric patients with chronic OME underwent TT placement, and 54 were included in the final analysis. After TT extrusion, participants were randomized into two groups: an autoinflation group using a handheld device (Eustachi) for five weeks, and an observation-only group. Patients were followed for two years post-extrusion, with periodic otoscopic and tympanometric assessments.
The autoinflation group showed a lower recurrence rate (19.2%) compared to the observation group (35.7%), although this difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7% vs. 28.6%). Tympanometric findings suggested more stable middle ear pressure in the autoinflation group. These results indicate that autoinflation is a safe, feasible, and non-invasive method that may support eustachian tube function and reduce the need for repeat TT placement in children following TT extrusion.
Detailed description
Otitis media with effusion (OME) is a prevalent pediatric condition that may lead to hearing loss and developmental delay. Tympanostomy tube (TT) placement is the standard treatment for persistent OME but does not address the underlying cause, and recurrence is common after TT extrusion. This study investigated whether autoinflation after TT extrusion could reduce OME recurrence and the need for reoperation.
In this prospective randomized controlled trial, 66 children aged 3 to 8 years with chronic OME were enrolled at a tertiary hospital. All underwent TT placement under general anesthesia and were followed bi-monthly in the outpatient clinic. After TT extrusion, 54 patients were randomized to either the autoinflation group (n = 26) or the observation group (n = 28). The autoinflation group used the Eustachi device twice daily for five weeks, with instructions provided to children and caregivers. Patients with adenoid hypertrophy, craniofacial anomalies, active otologic disease, or severe systemic disease were excluded.
Outcome measures included OME recurrence and TT reoperation rates over two years, evaluated through otoscopy and tympanometry. The recurrence rate was lower in the autoinflation group (19.2%) than in the observation group (35.7%), though the difference was not statistically significant. However, the reoperation rate was significantly lower in the autoinflation group (7.7%) compared to the observation group (28.6%, p = 0.048). Tympanometry results also showed stable middle ear pressure in the autoinflation group, whereas the observation group experienced a decline in type A tympanograms and an increase in type C patterns over time.
These findings suggest that autoinflation may promote functional rehabilitation of the eustachian tube and maintain middle ear ventilation after TT extrusion. The intervention was well tolerated and feasible in a home setting with caregiver supervision. While autoinflation should not replace TT placement in persistent OME, it may serve as a valuable non-invasive strategy to reduce the risk of recurrence and the need for repeat surgery. Limitations include sample size and lack of quantitative compliance data, warranting future multicenter studies for validation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoinflation | Experimental | Device: EustachiParticipants perform autoinflation using the Eustachi device twice daily for 5 weeks after TT extrusion. |
| Observation | No intervention | –Participants are followed without autoinflation after TT extrusion (standard observation only). |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 8 years
- Clinical diagnosis of chronic otitis media with effusion (OME)
- Underwent tympanostomy tube (TT) placement for persistent OME lasting more than 3 months
- Capable of performing autoinflation, as assessed by the physician
- Caregiver willing to provide informed consent and assist with at-home device use
Key exclusion criteria (6 listed)
- Presence of adenoid hypertrophy or tonsillar hypertrophy
- History of craniofacial anomalies (e.g., cleft palate)
- Current otologic disease such as otorrhea or tympanic membrane perforation
- Acute otitis media or signs of active inflammation at enrollment
- Underlying severe systemic disease or immunodeficiency
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 |
|---|---|---|
| EustachiA handheld device that delivers pulsed air through the nasal passage to facilitate opening of the eustachian tube. Participants in this group use the device twice daily for 5 weeks after tympanostomy tube extrusion. | Device | Autoinflation |
Primary outcome
Recurrence rate of otitis media with effusion (OME)
Time frame: Up to 24 months after tympanostomy tube extrusion
The proportion of patients with a recurrence of OME in the affected ear(s), diagnosed by otoscopy and/or tympanometry, during a 2-year follow-up period after tympanostomy tube extrusion.
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 14 Aug 2025.
- Results publication: PubMed 23728660Perera R, Glasziou PP, Heneghan CJ, McLellan J, Williamson I. Autoinflation for hearing loss associated with otitis media with effusion. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD006285. doi: 10.1002/14651858.CD006285.pub2.
- Derived from this study: PubMed 41817520Na HS, Lee S, Kim SH, Lee HM, Oh SJ, Lee IW, Choi SW. Autoinflation After Tympanostomy Tube Extrusion in Otitis Media With Effusion: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 May 1;152(5):472-478. doi: 10.1001/jamaoto.2026.0044.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared for this study. This decision was made due to privacy considerations and the absence of a formal data-sharing plan.
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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 Eustachi in people with Otitis Media With Effusion (OME) and Eustachian Tube Dysfunction, run by Pusan National University Hospital at 1 site in South Korea.
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 5 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 14 Aug 2025. 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 South Korea. 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?
Recurrence rate of otitis media with effusion (OME) (time frame: Up to 24 months after tympanostomy tube extrusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07122999, which also lists 2 linked publications.
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 14 Aug 2025.