NCT03886740

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

March 19, 2019

Last Update Submit

February 6, 2023

Conditions

Eustachian Tube Dysfunction of Right Ear (Diagnosis)Eustachian Tube Dysfunction of Both Ears (Diagnosis)Eustachian Tube DysfunctionEustachian Tube Dysfunction of Left Ear

Keywords

Eustachian Tube DysfunctionEustachian Tube balloon dilationEustachian Tube dilationTympanostomy

Outcome Measures

Primary Outcomes (10)

  • ETDQ-7 score

    The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.

    Baseline

  • ETDQ-7 score

    The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.

    6-weeks

  • ETDQ-7 score

    The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.

    3-months

  • ETDQ-7 score

    The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.

    6-months

  • ETDQ-7 score

    The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.

    1-year

  • Tympanogram

    The patient's post-op tympanogram will be recorded to compare to follow-up visits.

    Baseline

  • Tympanogram

    The patient's post-op tympanogram will be compared to their pre-op tympanogram.

    6-weeks

  • Tympanogram

    The patient's post-op tympanogram will be compared to their pre-op tympanogram.

    3-months

  • Tympanogram

    The patient's post-op tympanogram will be compared to their pre-op tympanogram.

    6-months

  • Tympanogram

    The patient's post-op tympanogram will be compared to their pre-op tympanogram.

    1 year

Study Arms (2)

Tympanostomy with tubes

EXPERIMENTAL

Tympanostomy with pressure equalization tube placement with Ventilation (Tympanostomy) Tubes

Procedure: Reducing symptoms of Eustachian tube dysfunction

Eustachian tube (ET) dilation

EXPERIMENTAL

Eustachian tube (ET) dilation with ACCLARENT AERA® Eustachian Tube Balloon Dilation System

Procedure: Reducing symptoms of Eustachian tube dysfunction

Interventions

Reducing symptoms of Eustachian tube dysfunctionPROCEDURE

One of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared

Eustachian tube (ET) dilationTympanostomy with tubes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Feldmann H. [The Eustachian tube and its role in the history of otology. Images from the history of otorhinolaryngology, presented by instruments from the collection of the Ingolstadt German History Museum]. Laryngorhinootologie. 1996 Dec;75(12):783-92. doi: 10.1055/s-2007-997676. German.

    PMID: 9081287BACKGROUND

  • Schilder AG, Bhutta MF, Butler CC, Holy C, Levine LH, Kvaerner KJ, Norman G, Pennings RJ, Poe D, Silvola JT, Sudhoff H, Lund VJ. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. 2015 Oct;40(5):407-11. doi: 10.1111/coa.12475. No abstract available.

    PMID: 26347263BACKGROUND

  • McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012 May;122(5):1137-41. doi: 10.1002/lary.23223. Epub 2012 Feb 28.

    PMID: 22374681BACKGROUND

  • Teixeira MS, Swarts JD, Alper CM. Accuracy of the ETDQ-7 for Identifying Persons with Eustachian Tube Dysfunction. Otolaryngol Head Neck Surg. 2018 Jan;158(1):83-89. doi: 10.1177/0194599817731729. Epub 2017 Sep 26.

    PMID: 28949806BACKGROUND

  • Browning GG, Gatehouse S. The prevalence of middle ear disease in the adult British population. Clin Otolaryngol Allied Sci. 1992 Aug;17(4):317-21. doi: 10.1111/j.1365-2273.1992.tb01004.x.

    PMID: 1526050BACKGROUND

  • Gluth MB, McDonald DR, Weaver AL, Bauch CD, Beatty CW, Orvidas LJ. Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2011 May;137(5):449-55. doi: 10.1001/archoto.2011.56.

    PMID: 21576556BACKGROUND

  • Pappas JJ. Middle ear ventilation tubes. Laryngoscope. 1974 Jul;84(7):1098-117. doi: 10.1288/00005537-197407000-00004. No abstract available.

    PMID: 4842776BACKGROUND

  • Llewellyn A, Norman G, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. 2014 Jul;18(46):1-180, v-vi. doi: 10.3310/hta18460.

    PMID: 25029951BACKGROUND

  • Nguyen LH, Manoukian JJ, Yoskovitch A, Al-Sebeih KH. Adenoidectomy: selection criteria for surgical cases of otitis media. Laryngoscope. 2004 May;114(5):863-6. doi: 10.1097/00005537-200405000-00014.

    PMID: 15126745BACKGROUND

  • Bluestone CD, Cantekin EI, Beery QC. Certain effects of adenoidectomy of Eustachian tube ventilatory function. Laryngoscope. 1975 Jan;85(1):113-27. doi: 10.1288/00005537-197501000-00009.

    PMID: 1089852BACKGROUND

  • Poe D, Anand V, Dean M, Roberts WH, Stolovitzky JP, Hoffmann K, Nachlas NE, Light JP, Widick MH, Sugrue JP, Elliott CL, Rosenberg SI, Guillory P, Brown N, Syms CA 3rd, Hilton CW, McElveen JT Jr, Singh A, Weiss RL Jr, Arriaga MA, Leopold JP. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.

    PMID: 28940574BACKGROUND

  • Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.

    PMID: 29912819BACKGROUND

  • Anand V, Poe D, Dean M, Roberts W, Stolovitzky P, Hoffmann K, Nachlas N, Light J, Widick M, Sugrue J, Elliott CL, Rosenberg S, Guillory P, Brown N, Syms C, Hilton C, McElveen J, Singh A, Weiss R, Arriaga M, Leopold J. Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group. Otolaryngol Head Neck Surg. 2019 Apr;160(4):687-694. doi: 10.1177/0194599818821938. Epub 2019 Jan 8.

    PMID: 30620688BACKGROUND

  • Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

    PMID: 40008607DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Kim, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: One arm will be treated with tympanostomy with pressure equalization tube placement and the other with Eustachian tube (ET) dilation. Their Eustachian Tube Dysfunction Questionnaire-7 scores will be collected over time and compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 22, 2019

Study Start

May 1, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share