Eustachian Tube DysfunctionNCT03886740
Tympanostomy Tubes Versus Eustachian Tube Dilation
A study testing Reducing symptoms of Eustachian tube dysfunction in people with Eustachian Tube Dysfunction and Eustachian Tube Dysfunction of Left Ear, run by Columbia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eustachian Tube Dysfunction, Eustachian Tube Dysfunction of Left Ear, Eustachian Tube Dysfunction of Right Ear (Diagnosis)
- What is being tested?
- Reducing symptoms of Eustachian tube dysfunction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
The eustachian tube serves to ventilate and equalize middle ear pressure; clear secretions from the middle ear with mucociliary action; and protect the middle ear from sounds, pathogens, and secretions from the nasopharynx. First described anatomically by Eustachius in 1563 and with its exact function worked out a century later, Valsalva realized in 1703 that its opening was dynamic, not static, and described the namesake maneuver to expel pus from the middle ear into the external auditory canal. By the mid 18th century, multiple authors had attempted Eustachian tube catheterization and by the early 19th century, catheterization with irrigation and air insufflation had been described.(1) This shows how Eustachian tube dilation has been a known treatment for centuries, despite its relative obscurity prior to this decade. ET dysfunction is a common diagnosis many patients receiving care from an otologist or otolaryngologist receive. Dysfunction can be broken down into dilatory, which is caused by inflammation such as a virus, baro-challenge induced such as in scuba divers or those taking flights and patulous, which is of unclear etiology.(2) Symptoms are thought to include but are not limited to ear fullness, the sensation that the ear is underwater, otalgia, muffled hearing, tinnitus, autophony and ear popping amongst others. Clear diagnostic criteria are not present, though it is generally felt that a combination of symptoms and objective findings on otoscopy or tympanogram are enough to support the diagnosis. Many have resorted to using the Eustachian Tube Dysfunction Questionnaire-7 which is a validated symptom driven assessment, although it is only moderately associated with objective measures of ET dysfunction. (3,4) The only population-based study looking at prevalence used otoscopy, tympanogram and audiometry to estimate that it affects 0.9% of adults.(5) Unfortunately, there is currently no gold standard for treatment of ET dysfunction.
The only randomized control study of medical treatments showed no impact of nasal steroids on ET dysfunction.(6) The most common surgical option is a tympanostomy tube, which has been used since the 1950s for both middle ear effusions and ET dysfunction.(7) Tympanostomy tubes can alleviate tympanic membrane retraction, atelectasis and effusion, although they do not address the underlying etiology of the ET dysfunction. Numerous nonrandomized and or noncontrolled studies have showed improvement in symptoms with tympanostomy tube placement. Depending on the study and the definition, 70-100% improvement has been reported. Despite this, high-level evidence for tympanostomy tube efficacy in ET dysfunction remains lacking.(8) Adenoidectomy has also been proposed as a way to improve ET function, but not surprisingly, most studies have shown that it only helps if the adenoids are found to be abutting or obstructing the torus tubarii.(9,10) Furthermore, these studies focus on children, and the adenoid pad is not likely to be a contributing factor in most adults. Eustachian tube balloon dilation recently came back into the mainstream beginning with the 2010 study by Ockermann et al. which showed the procedure was safe and produced good results in a small cohort. Numerous studies since then have shown efficacy, including two separate multicenter randomized controlled trials published in 2017 and 2018. Both of these showed statistically and clinically significant superiority of ET balloon dilation over control as measured by improvement in ETDQ-7 and tympanogram type at up to 1 year. (11,12,13)
- Conditions
- Eustachian Tube Dysfunction, Eustachian Tube Dysfunction of Left Ear, Eustachian Tube Dysfunction of Right Ear (Diagnosis), Eustachian Tube Dysfunction of Both Ears (Diagnosis)
- Being tested
- Reducing symptoms of Eustachian tube dysfunction
- Keywords
- Eustachian Tube Dysfunction, Eustachian Tube balloon dilation, Eustachian Tube dilation, Tympanostomy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing symptoms of Eustachian tube dysfunctionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Tympanostomy with tubes | Experimental | Tympanostomy with pressure equalization tube placement with Ventilation (Tympanostomy) Tubes Receives: Procedure: Reducing symptoms of Eustachian tube dysfunction |
| Eustachian tube (ET) dilation | Experimental | Eustachian tube (ET) dilation with ACCLARENT AERA® Eustachian Tube Balloon Dilation System Receives: Procedure: Reducing symptoms of Eustachian tube dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-year
Tympanogram
The patient's post-op tympanogram will be recorded to compare to follow-up visits.
Measured: Baseline
Tympanogram
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Measured: 6-weeks
Tympanogram
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Measured: 3-months
Tympanogram
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Measured: 6-months
Tympanogram
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: Difficulty enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hae-Ok Kim, Columbia University
- Investigators
- Ana Kim, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886740
- Sponsor's protocol ID
- AAAS2555
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9081287Schilder 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.
PubMed 26347263McCoul 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.
PubMed 22374681Teixeira 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.
PubMed 28949806Browning 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.
PubMed 1526050Gluth 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.
PubMed 21576556Pappas JJ. Middle ear ventilation tubes. Laryngoscope. 1974 Jul;84(7):1098-117. doi: 10.1288/00005537-197407000-00004. No abstract available.
PubMed 4842776Llewellyn 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.
PubMed 25029951Nguyen 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.
PubMed 15126745Bluestone 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.
PubMed 1089852Poe 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.
PubMed 28940574Meyer 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.
PubMed 29912819Anand 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.
PubMed 30620688Swords 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.
PubMed 40008607
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tympanostomy Tubes Versus Eustachian Tube Dilation
- ClinicalTrials.gov ID
- NCT03886740
- Acronym / sponsor ID
- AAAS2555
- Conditions
- Eustachian Tube Dysfunction, Eustachian Tube Dysfunction of Left Ear, Eustachian Tube Dysfunction of Right Ear (Diagnosis), Eustachian Tube Dysfunction of Both Ears (Diagnosis)
- Keywords
- Eustachian Tube Dysfunction, Eustachian Tube balloon dilation, Eustachian Tube dilation, Tympanostomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty enrolling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 22 Mar 2019 (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.
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.
Detailed description
The eustachian tube serves to ventilate and equalize middle ear pressure; clear secretions from the middle ear with mucociliary action; and protect the middle ear from sounds, pathogens, and secretions from the nasopharynx. First described anatomically by Eustachius in 1563 and with its exact function worked out a century later, Valsalva realized in 1703 that its opening was dynamic, not static, and described the namesake maneuver to expel pus from the middle ear into the external auditory canal. By the mid 18th century, multiple authors had attempted Eustachian tube catheterization and by the early 19th century, catheterization with irrigation and air insufflation had been described.(1) This shows how Eustachian tube dilation has been a known treatment for centuries, despite its relative obscurity prior to this decade. ET dysfunction is a common diagnosis many patients receiving care from an otologist or otolaryngologist receive. Dysfunction can be broken down into dilatory, which is caused by inflammation such as a virus, baro-challenge induced such as in scuba divers or those taking flights and patulous, which is of unclear etiology.(2) Symptoms are thought to include but are not limited to ear fullness, the sensation that the ear is underwater, otalgia, muffled hearing, tinnitus, autophony and ear popping amongst others. Clear diagnostic criteria are not present, though it is generally felt that a combination of symptoms and objective findings on otoscopy or tympanogram are enough to support the diagnosis. Many have resorted to using the Eustachian Tube Dysfunction Questionnaire-7 which is a validated symptom driven assessment, although it is only moderately associated with objective measures of ET dysfunction. (3,4) The only population-based study looking at prevalence used otoscopy, tympanogram and audiometry to estimate that it affects 0.9% of adults.(5) Unfortunately, there is currently no gold standard for treatment of ET dysfunction.
The only randomized control study of medical treatments showed no impact of nasal steroids on ET dysfunction.(6) The most common surgical option is a tympanostomy tube, which has been used since the 1950s for both middle ear effusions and ET dysfunction.(7) Tympanostomy tubes can alleviate tympanic membrane retraction, atelectasis and effusion, although they do not address the underlying etiology of the ET dysfunction. Numerous nonrandomized and or noncontrolled studies have showed improvement in symptoms with tympanostomy tube placement. Depending on the study and the definition, 70-100% improvement has been reported. Despite this, high-level evidence for tympanostomy tube efficacy in ET dysfunction remains lacking.(8) Adenoidectomy has also been proposed as a way to improve ET function, but not surprisingly, most studies have shown that it only helps if the adenoids are found to be abutting or obstructing the torus tubarii.(9,10) Furthermore, these studies focus on children, and the adenoid pad is not likely to be a contributing factor in most adults. Eustachian tube balloon dilation recently came back into the mainstream beginning with the 2010 study by Ockermann et al. which showed the procedure was safe and produced good results in a small cohort. Numerous studies since then have shown efficacy, including two separate multicenter randomized controlled trials published in 2017 and 2018. Both of these showed statistically and clinically significant superiority of ET balloon dilation over control as measured by improvement in ETDQ-7 and tympanogram type at up to 1 year. (11,12,13)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tympanostomy with tubes | Experimental | Procedure: Reducing symptoms of Eustachian tube dysfunctionTympanostomy with pressure equalization tube placement with Ventilation (Tympanostomy) Tubes |
| Eustachian tube (ET) dilation | Experimental | Procedure: Reducing symptoms of Eustachian tube dysfunctionEustachian tube (ET) dilation with ACCLARENT AERA® Eustachian Tube Balloon Dilation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Reducing symptoms of Eustachian tube dysfunctionOne of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared | Procedure or surgery | Eustachian tube (ET) dilation, Tympanostomy with tubes |
Primary outcome
ETDQ-7 score
Time frame: Baseline
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
ETDQ-7 score
Time frame: 6-weeks
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
ETDQ-7 score
Time frame: 3-months
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
ETDQ-7 score
Time frame: 6-months
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
ETDQ-7 score
Time frame: 1-year
The questionnaire contains 7 questions and total score will be divided by 7 to get mean score. Each visit will be averaged individually.
Tympanogram
Time frame: Baseline
The patient's post-op tympanogram will be recorded to compare to follow-up visits.
Tympanogram
Time frame: 6-weeks
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Tympanogram
Time frame: 3-months
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Tympanogram
Time frame: 6-months
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Tympanogram
Time frame: 1 year
The patient's post-op tympanogram will be compared to their pre-op tympanogram.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 9081287Feldmann 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.
- Background: PubMed 26347263Schilder 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.
- Background: PubMed 22374681McCoul 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.
- Background: PubMed 28949806Teixeira 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.
- Background: PubMed 1526050Browning 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.
- Background: PubMed 21576556Gluth 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.
- Background: PubMed 4842776Pappas JJ. Middle ear ventilation tubes. Laryngoscope. 1974 Jul;84(7):1098-117. doi: 10.1288/00005537-197407000-00004. No abstract available.
- Background: PubMed 25029951Llewellyn 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.
- Background: PubMed 15126745Nguyen 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.
- Background: PubMed 1089852Bluestone 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.
- Background: PubMed 28940574Poe 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.
- Background: PubMed 29912819Meyer 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.
- Individual participant dataSharing planned: No
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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.
Ana Kim, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Reducing symptoms of Eustachian tube dysfunction in people with Eustachian Tube Dysfunction and Eustachian Tube Dysfunction of Left Ear, run by Columbia University.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
ETDQ-7 score (time frame: Baseline). The study lists 10 primary outcomes in all. 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 NCT03886740, which also lists 14 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 8 Feb 2023.