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Eustachian Tube Growth and Development

Eustachian Tube Growth and Development: Anatomy/Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00422929
Enrollment
126
Registered
2007-01-17
Start date
2006-08-31
Completion date
2018-08-24
Last updated
2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

otitis media, ear, acute otitis, middle ear, Eustachian tube, recurrent acute otitis media, chronic otitis media with effusion, no significant history of otitis media

Brief summary

This study is to measure over time (from 3 years until 13 years of age) Eustachian tube function (the way the Eustachian tube works) and facial growth in groups of children with two types of middle-ear disease and with little past middle-ear disease. These measures will be used to determine if facial growth is related to improved Eustachian tube function, to see if the better function explains why young children who have middle-ear disease outgrow it as they get older, and to determine if these measures are different for the children in the three groups defined by disease history.

Detailed description

The existing literature documents an important role for the Eustachian tube (ET) in the pathogenesis and/or persistence of otitis media (OM). Cross-sectional studies report a lower prevalence of OM in older children, a better ET pressure-regulating function in older children and age-related differences in ET form, length and width, and the vector orientation of the paratubal musculature. These growth-related changes in ET structural relationships are demonstrably predictive of increasingly more efficient ET function (ETF) and, because the ET and paratubal musculature are intimately related to the cranial base, the vector orientation of the ET system can be reconstructed from osteological or radiographic data. Together, these observations suggest that measurable, age-related changes in ET-paratubal muscle vector relationships are reflected in more efficient ETF and, by consequence, a decreased OM risk. The overall goal of the proposed longitudinal study is to evaluate the validity of this hypothesis.

Interventions

None listed

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 3 Years
Healthy volunteers
Yes

Inclusion criteria

* 3 years of age * History of middle ear disease must fit into one of the 3 categories of ear history * With or without patent tympanostomy tubes at time of entry * Generally good health

Exclusion criteria

* Cleft palate or other syndromes predisposing to otitis * History of significant orthodontic treatment or plan for such * Cholesteatoma or other past ear surgery other than tubes * Unable to cooperate for testing

Design outcomes

Primary

MeasureTime frameDescription
change in Eustachian tube function5 yearsEustachian tube function is tested yearly from age 3 years through age 7 years

Secondary

MeasureTime frameDescription
change in craniofacial measures5 yearscross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years

Other

MeasureTime frameDescription
change in cephalometric variables5 yearsmeasurements obtained on cephalometric x-rays
change in later Eustachian tube function11 yearsEustachian tube function tested yearly through 13 years of age

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026