Eustachian Tube DysfunctionNCT03850197
Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing
An observational study of Eustachian Tube Dysfunction, run by Cuneyt M. Alper at 1 site in United States.
Trial summary
The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- EarPopper, Tympanometry and Tubomanometry
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 18 Nov 2019
- Phase
- Observational
- 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 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 10 healthy adults (aged 18-60), 5 healthy children (aged 5-17), 10 otherwise healthy adults with ETD (aged 18-60), and 5 otherwise healthy children with ETD (aged 5-17) with bilaterally intact TM's will be enrolled after obtaining informed consent. Complete histories will be taken with a focus on any ear-related problems.
Who may be able to join
- ETD participants:
- Bilaterally intact tympanic membranes
- aged 5 to 60; generally good health
- ability to understand and give informed consent
- history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear fluids, or prior ETD diagnosis
- ability to perform maneuvers that will be done during the testing protocol.
Show all 14Show fewer
- Control participants
- Bilaterally intact tympanic membranes
- aged 5 to 60
- generally good health
- ability to understand and give informed consent
- no personal history of recurrent otitis media or other middle--ear disease
- ability to perform maneuvers that will be done during the testing protocol
- no difficulty equalizing middle--ear pressures in daily life.
Who cannot join
- ETD participants:
- Cold/allergic rhinitis (temporary) on presentation
- current dental problem or dental work within 7 days (temporary)
- history of ossicular reconstruction
- history of tympanoplasty
- syndromes predisposing to otitis media
Show all 19Show fewer
- extant middle--ear disease
- inability to complete testing protocols
- tympanic membrane perforation
- abnormal tympanogram (type B tympanogram)
- BMI >40
- history of congenital heart disease
- prior radiation to head and neck
- uncontrolled respiratory disease
- any medical condition or use of medication for which the study physician feels study procedures would not be in the subject's best interest.
- In adults, a positive urine pregnancy test (in females), blood pressure above 140/90, glaucoma, and sensitivity to drugs used to prepare the nose for endoscopic examination will also exclude potential participants.
- Control participants:
- (in addition to above) significant middle--ear disease history
- evidence of middle ear pathology.
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when flying in an airplane or going up a tall building in an elevator. Many people with ETD also suffer from ear problems such as repeated middle-ear infections or fluid in the ears. However, there are very few easily-administered tests to measure and assess Eustachian tube function (ETF). Tubomanometry is one of these tests, however it is expensive and used to measure ETF only in research settings. In this study, the investigators propose that using a combination of two readily available devices, the EarPopper and a tympanometer, will work in a manner similar to a Tubomanometer to test ET function.
Read the detailed description
There is no current universally-accepted set of functional tests or scoring systems for the diagnosis of ETD or measure of the pressure-regulating function of the ET; current practice shows that the diagnosis of ETD relies largely on clinical observation. Though there are several tests that have been developed to characterize ETF, many of them require specialized equipment and trained personnel to administer the test, which are only available in specialized testing centers. As such, this study aims to compare the use of the EarPopper plus tympanometry to Tubomanometry as a ETF test.
Tubomanometry is a simple in-office test based on the Politzer maneuver, in which air is blown into one of the nostrils while occluding the contralateral nostril and swallowing. The tubomanometer consists of an air pump attached to a manometer to adjust the target pressure, a two-pronged nose piece to deliver a controlled airflow to the nostrils and an external ear canal sensor to detect displacement of the tympanic membrane (TM). Since the middle ear is a closed system, displacement of the TM during a swallow is considered a successful ET opening. Tubomanometry is easily tolerated by both adults and children is currently used most widely to evaluate ETF changes after ET balloon dilation. The EarPopper is, like the tubomanometer, a modified politzer device and is used as a treatment device for ET obstruction. It introduces a continuous airflow into the nostril and has no external ear canal probe. The user perceives the ET opening as a subjective sensation of ear fulness. In this pilot study, the investigators will test the feasibility of a new ETF test protocol that will use the EarPopper to trigger the opening of the ET followed by a tympanogram to confirm if there was a change in middle ear pressure. The investigators expect that the combination of these two devices will be comparable to the Tubomanometry test, which will also be performed in the same test session.
Previous studies show that ET opening efficiency is determined by the coordinated function of paratubal muscles, especially of the levator (mLVP) and tensor veli palatini (mTVP) muscles. Nasal endoscopy video recordings have shown a large variability in soft palate closure, as it depends largely on individual effort. For this reason, besides swallowing, the investigators will also employ two additional methods to standardize the elevation of the soft palate and facilitate the opening of the ET: the Fish maneuver (puffing the cheeks and blowing out against a closed mouth) and the EMST-150 device (blowing into the device with a preset low and high resistances). As part of the development of this new testing protocol, these three maneuvers will be used during the EarPopper plus tympanometry and Tubomanometry tests. They will be performed during the EarPopper test, with concurrent video-otoscopy recordings to detect movement of the tympanic membrane that could be interpreted as an ET opening, and during trans-nasal video-endoscopy to record the movement and positioning of the soft palate.
The investigators expect that, in comparing the maneuvers performed during EarPopper plus tympanometry and Tubomanometry tests, they will assess the feasibility of the protocol, define maneuvers to standardize paratubal muscular contraction and determine if the EarPopper plus tympanometry measurements are comparable to Tubomanometry.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- EarPopper, Tympanometry, Tubomanometry
- Keywords
- Tubomanometry, EarPopper, Eustachian tube function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarPopperDevice
The EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, "Fish", blowing out into the EMST-150).
TympanometryDevice
The Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change.
TubomanometryDevice
Tubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, "Fish", blowing out into the EMST-150).
| Study group | Role | What they receive |
|---|---|---|
| TMM followed by EarPopper + Tympanometry | Participants will be asked to complete the tubomanometry (TMM) then EarPopper plus tympanometry tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize Eustachian tube (ET) pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, "Fish" maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. Receives: Device: EarPopper; Device: Tympanometry; Device: Tubomanometry | |
| EarPopper + Tympanometry followed by TMM | Participants will be asked to complete the EarPopper plus tympanometry then TMM tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize ET pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, "Fish" maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. Receives: Device: EarPopper; Device: Tympanometry; Device: Tubomanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle ear pressure change after a swallow
The subject's middle ear pressure will be measured before and after they are asked to swallow, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening.
Measured: Immediately before/after swallow
Secondary outcomes (2)
Middle ear pressure change after "Fish" maneuver
The subject's middle ear pressure will be measured before and after they are asked to carry out the "Fish" maneuver, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening. The "Fish" maneuver is an effort-dependent method of elevating the soft palate, and will provide further qualitative data on Eustachian tube function.
Measured: Immediately before/after "Fish" maneuver
Middle ear pressure change after blowing into EMST-150
The subject's middle ear pressure will be measured before and after they are asked to blow out against different levels of resistance into the EMST-150, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening. Blowing into the EMST-150 is a standardized method of elevating the soft palate, and will provide further qualitative data on Eustachian tube function.
Measured: Immediately before/after blowing into EMST-150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start27 Feb 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuneyt M. Alper
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh
- Responsible party
- Sponsor-investigator, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850197
- Sponsor's protocol ID
- PRO18050569
- Other IDs
- P50DC007667
- Status last verified
- Nov 2020
- First submitted
- 13 Feb 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26347263Ars B, Dirckx JJJ. Tubomanometry. In: Ars B, ed. Fibrocartilaginous Eustachian Tube-Middle ear cleft. The Hague, The Netherlands: Kugler Publications; 2003:151-158.
Esteve D. Tubomanometry and Pathology. In: Ars B, ed. Fibrocartilaginous Eustachian Tube - Middle Ear Cleft. The Hauge, The Netherlands: Kugler Publications; 2003:159-175.
Smith ME, Zou CC, Baker C, Blythe AJC, Hutchinson PJA, Tysome JR. The repeatability of tests of eustachian tube function in healthy ears. Laryngoscope. 2017 Nov;127(11):2619-2626. doi: 10.1002/lary.26534. Epub 2017 Feb 22.
PubMed 28224679Gurtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol. 2015 Mar;36(3):437-43. doi: 10.1097/MAO.0000000000000631.
PubMed 25356762Schroder S, Lehmann M, Ebmeyer J, Upile T, Sudhoff H. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015 Dec;40(6):629-38. doi: 10.1111/coa.12429.
PubMed 25867023Sheer FJ, Swarts JD, Ghadiali SN. Finite element analysis of eustachian tube function in cleft palate infants based on histological reconstructions. Cleft Palate Craniofac J. 2010 Nov;47(6):600-10. doi: 10.1597/09-131. Epub 2010 Mar 10.
PubMed 20500073Alper CM, Teixeira MS, Swarts JD, Doyle WJ. Quantitative description of eustachian tube movements during swallowing as visualized by transnasal videoendoscopy. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):160-8. doi: 10.1001/jamaoto.2014.3002.
PubMed 25474183
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing in Children and Adults
- ClinicalTrials.gov ID
- NCT03850197
- Acronym / sponsor ID
- PRO18050569
- Conditions
- Eustachian Tube Dysfunction
- Keywords
- Tubomanometry, EarPopper, Eustachian tube function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cuneyt M. AlperUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 21 Feb 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 Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when flying in an airplane or going up a tall building in an elevator. Many people with ETD also suffer from ear problems such as repeated middle-ear infections or fluid in the ears. However, there are very few easily-administered tests to measure and assess Eustachian tube function (ETF). Tubomanometry is one of these tests, however it is expensive and used to measure ETF only in research settings. In this study, the investigators propose that using a combination of two readily available devices, the EarPopper and a tympanometer, will work in a manner similar to a Tubomanometer to test ET function.
Detailed description
There is no current universally-accepted set of functional tests or scoring systems for the diagnosis of ETD or measure of the pressure-regulating function of the ET; current practice shows that the diagnosis of ETD relies largely on clinical observation. Though there are several tests that have been developed to characterize ETF, many of them require specialized equipment and trained personnel to administer the test, which are only available in specialized testing centers. As such, this study aims to compare the use of the EarPopper plus tympanometry to Tubomanometry as a ETF test.
Tubomanometry is a simple in-office test based on the Politzer maneuver, in which air is blown into one of the nostrils while occluding the contralateral nostril and swallowing. The tubomanometer consists of an air pump attached to a manometer to adjust the target pressure, a two-pronged nose piece to deliver a controlled airflow to the nostrils and an external ear canal sensor to detect displacement of the tympanic membrane (TM). Since the middle ear is a closed system, displacement of the TM during a swallow is considered a successful ET opening. Tubomanometry is easily tolerated by both adults and children is currently used most widely to evaluate ETF changes after ET balloon dilation. The EarPopper is, like the tubomanometer, a modified politzer device and is used as a treatment device for ET obstruction. It introduces a continuous airflow into the nostril and has no external ear canal probe. The user perceives the ET opening as a subjective sensation of ear fulness. In this pilot study, the investigators will test the feasibility of a new ETF test protocol that will use the EarPopper to trigger the opening of the ET followed by a tympanogram to confirm if there was a change in middle ear pressure. The investigators expect that the combination of these two devices will be comparable to the Tubomanometry test, which will also be performed in the same test session.
Previous studies show that ET opening efficiency is determined by the coordinated function of paratubal muscles, especially of the levator (mLVP) and tensor veli palatini (mTVP) muscles. Nasal endoscopy video recordings have shown a large variability in soft palate closure, as it depends largely on individual effort. For this reason, besides swallowing, the investigators will also employ two additional methods to standardize the elevation of the soft palate and facilitate the opening of the ET: the Fish maneuver (puffing the cheeks and blowing out against a closed mouth) and the EMST-150 device (blowing into the device with a preset low and high resistances). As part of the development of this new testing protocol, these three maneuvers will be used during the EarPopper plus tympanometry and Tubomanometry tests. They will be performed during the EarPopper test, with concurrent video-otoscopy recordings to detect movement of the tympanic membrane that could be interpreted as an ET opening, and during trans-nasal video-endoscopy to record the movement and positioning of the soft palate.
The investigators expect that, in comparing the maneuvers performed during EarPopper plus tympanometry and Tubomanometry tests, they will assess the feasibility of the protocol, define maneuvers to standardize paratubal muscular contraction and determine if the EarPopper plus tympanometry measurements are comparable to Tubomanometry.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMM followed by EarPopper + Tympanometry | – | Device: EarPopper, Device: Tympanometry, Device: TubomanometryParticipants will be asked to complete the tubomanometry (TMM) then EarPopper plus tympanometry tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize Eustachian tube (ET) pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, "Fish" maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. |
| EarPopper + Tympanometry followed by TMM | – | Device: EarPopper, Device: Tympanometry, Device: TubomanometryParticipants will be asked to complete the EarPopper plus tympanometry then TMM tests for each ear, followed by video otoscopy. Nasal endoscopy will also be performed on adult subjects to visualize ET pharyngeal opening and the functional anatomy of surrounding structures during maneuvers. These maneuvers include swallowing, "Fish" maneuver, and blowing out into the EMST-150, and are used to elevate the soft palate to trigger an ET opening. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 10 healthy adults (aged 18-60), 5 healthy children (aged 5-17), 10 otherwise healthy adults with ETD (aged 18-60), and 5 otherwise healthy children with ETD (aged 5-17) with bilaterally intact TM's will be enrolled after obtaining informed consent. Complete histories will be taken with a focus on any ear-related problems.
Key inclusion criteria (14 listed)
- Bilaterally intact tympanic membranes
- aged 5 to 60; generally good health
- ability to understand and give informed consent
- history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear fluids, or prior ETD diagnosis
- ability to perform maneuvers that will be done during the testing protocol.
Key exclusion criteria (19 listed)
- Cold/allergic rhinitis (temporary) on presentation
- current dental problem or dental work within 7 days (temporary)
- history of ossicular reconstruction
- history of tympanoplasty
- syndromes predisposing to otitis media
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 |
|---|---|---|
| EarPopperThe EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, "Fish", blowing out into the EMST-150). | Device | EarPopper + Tympanometry followed by TMM, TMM followed by EarPopper + Tympanometry |
| TympanometryThe Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change. | Device | EarPopper + Tympanometry followed by TMM, TMM followed by EarPopper + Tympanometry |
| TubomanometryTubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, "Fish", blowing out into the EMST-150). | Device | EarPopper + Tympanometry followed by TMM, TMM followed by EarPopper + Tympanometry |
Primary outcome
Middle ear pressure change after a swallow
Time frame: Immediately before/after swallow
The subject's middle ear pressure will be measured before and after they are asked to swallow, while doing the tubomanometry or the Earpopper test. An increase in approximately 10daPa will be considered a Eustachian tube opening.
2 secondary outcomes
Middle ear pressure change after "Fish" maneuver
Time frame: Immediately before/after "Fish" maneuver
Middle ear pressure change after blowing into EMST-150
Time frame: Immediately before/after blowing into EMST-150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
- BackgroundArs B, Dirckx JJJ. Tubomanometry. In: Ars B, ed. Fibrocartilaginous Eustachian Tube-Middle ear cleft. The Hague, The Netherlands: Kugler Publications; 2003:151-158.
- BackgroundEsteve D. Tubomanometry and Pathology. In: Ars B, ed. Fibrocartilaginous Eustachian Tube - Middle Ear Cleft. The Hauge, The Netherlands: Kugler Publications; 2003:159-175.
- Background: PubMed 28224679Smith ME, Zou CC, Baker C, Blythe AJC, Hutchinson PJA, Tysome JR. The repeatability of tests of eustachian tube function in healthy ears. Laryngoscope. 2017 Nov;127(11):2619-2626. doi: 10.1002/lary.26534. Epub 2017 Feb 22.
- Background: PubMed 25356762Gurtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol. 2015 Mar;36(3):437-43. doi: 10.1097/MAO.0000000000000631.
- Background: PubMed 25867023Schroder S, Lehmann M, Ebmeyer J, Upile T, Sudhoff H. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015 Dec;40(6):629-38. doi: 10.1111/coa.12429.
- Background: PubMed 20500073Sheer FJ, Swarts JD, Ghadiali SN. Finite element analysis of eustachian tube function in cleft palate infants based on histological reconstructions. Cleft Palate Craniofac J. 2010 Nov;47(6):600-10. doi: 10.1597/09-131. Epub 2010 Mar 10.
- Background: PubMed 25474183Alper CM, Teixeira MS, Swarts JD, Doyle WJ. Quantitative description of eustachian tube movements during swallowing as visualized by transnasal videoendoscopy. JAMA Otolaryngol Head Neck Surg. 2015 Feb;141(2):160-8. doi: 10.1001/jamaoto.2014.3002.
- 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.
Cuneyt M Alper, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eustachian Tube Dysfunction, run by Cuneyt M. Alper at 1 site in United States.
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 14 inclusion and 19 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Middle ear pressure change after a swallow (time frame: Immediately before/after swallow). 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 NCT03850197, which also lists 8 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 13 Nov 2020.