WithdrawnNot Applicable

Tympanostomy Tubes Versus Eustachian Tube Dilation

Stopped: Difficulty enrolling

0Started 2019-05

Plain-language summary

The objective of this study is to determine whether tympanostomy with pressure equalization tube placement or Eustachian tube (ET) dilation is superior at reducing symptoms of patients with ET dysfunction. Given the apparent promise of Eustachian tube dilation and the lack of head to head comparison to the more traditional tympanostomy tube, this study seeks to compare them in a head to head manner in order to assess superiority in regards to ETDQ-7 and tympanogram improvements.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: Determined to have chronic Eustachian tube dysfunction of at least 3 month duration based on a score of ≥ 14.5 on the Eustachian tube dysfunction questionnaire-7 (ETDQ-7), regardless of tympanogram status Exclusion Criteria: * Insurance that does reimburse for ET balloon dilation * Patients with acute upper respiratory infection * Tympanic membrane perforation * Known middle ear disease such as cholesteatoma, acute otitits media, history of head and neck radiation, history of cleft palate, cystic fibrosis, ciliary dyskinesia, nasopharyngeal mass and patulous eustachian tube

What they're measuring

ETDQ-7 score

Timeframe: Baseline

ETDQ-7 score

Timeframe: 6-weeks

ETDQ-7 score

Timeframe: 3-months

ETDQ-7 score

Timeframe: 6-months

ETDQ-7 score

Timeframe: 1-year

Tympanogram

Timeframe: Baseline

Tympanogram

Timeframe: 6-weeks

Tympanogram

Timeframe: 3-months

Tympanogram

Timeframe: 6-months

Trial details

NCT IDNCT03886740

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08

View on ClinicalTrials.gov More Eustachian Tube Dysfunction trials