Autoinflation as a Eustachian Tube Rehabilitation

NCT07122999 | Completed DMC

• 1 other identifier: 2006-016-092
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Otitis Media With Effusion (OME); Eustachian Tube Dysfunction

Keywords

Autoinflation; Recurrence; Middle Ear Ventilation; Otitis Media with Effusion

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months after tympanostomy tube extrusion

Study Arms (2)

Autoinflation

EXPERIMENTAL

Participants perform autoinflation using the Eustachi device twice daily for 5 weeks after TT extrusion.

Device: Eustachi

Observation

NO INTERVENTION

Participants are followed without autoinflation after TT extrusion (standard observation only).

Interventions

Eustachi DEVICE

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.

Autoinflation

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, Seo-Gu, 49241, South Korea

Location

Related Publications (1)

• 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.

  PMID: 23728660 RESULT

MeSH Terms

Conditions

Otitis Media with Effusion; Recurrence

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: August 7, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2019
• Primary Completion: October 4, 2019
• Study Completion: August 31, 2022
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)