Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study evaluates the usefulness and safety of using a balloon to dilate (make larger) the Eustachian tube in adults who have middle-ear disease due to Eustachian tube dysfunction.

Detailed Description
-----------------
The Eustachian tube is a biological tube that connects the back of the nose to the middle ear. It is usually closed but needs to be actively opened by the action of certain muscles during swallowing, yawning, and other activities which keeps the air pressure in the middle ear (the part of the ear behind the eardrum) the same as the air pressure in the environment. If the Eustachian tube does not open during swallowing, the middle-ear pressure progressively decreases and persons may have the feeling of a stuffed up and/or full middle ear, may have difficulty hearing and/or may develop fluid in their middle ear. The usual treatment for a Eustachian tube that does not open well is to insert a tiny tube (called a ventilation or tympanostomy tube) into the eardrum to keep the air pressure in the middle ear the same as in the environment. However, those tubes naturally fall out over time, and if the Eustachian tube opening function had not improved while they were in place, new tubes will need to be inserted. In the past few years, doctors in the U.S. and Europe described a simple procedure called balloon dilation of the Eustachian tube (BDET) or balloon tuboplasty that they believe corrects the underlying cause of Eustachian tube dysfunction and resolves its symptoms, signs and consequences. For that procedure, a tiny balloon is inserted into the Eustachian tube, inflated to physically open the Eustachian tube, deflated and then removed. Doctors who have used the method in adults and children with symptoms of Eustachian tube dysfunction reported that BDET is safe and causes a short-term and, perhaps, a long-term resolution of symptoms. However, no one has measured Eustachian tube function before and after the procedure, and it is not known if BDET truly improves that function or not, and if so, how that function is changed. In this study, we will enroll adult subjects with a tympanostomy tube inserted into at least one eardrum or a chronic perforation in at least one eardrum for physician-diagnosed Eustachian tube dysfunction or middle-ear fluid and document the presence/absence of measurable Eustachian tube dysfunction using standard tests. If present, we will determine if the Eustachian tube dysfunction improves after medical treatment of other diseases known to cause Eustachian tube dysfunction. If the Eustachian tube dysfunction does not significantly improve, we will perform the BDET procedure and measure the change in Eustachian tube function at different times after the procedure.

Official Title
-----------------
Balloon Dilation in Selected Subjects With Refractory Eustachian Tube Dysfunction

Conditions
-----------------
Eustachian Tube Dysfunction

Intervention / Treatment
-----------------
* Procedure: Balloon dilation of the Eustachian tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: has functional ventilation tube or a chronic perforation in at least one ear; history of Eustachian tube dysfunction and/or otitis media with effusion; history of middle-ear effusion at least once; otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis; BMI of less than 35; no history of difficult intubation; no known family history of malignant hyperthermia. Exclusion Criteria: history of adverse reaction to any study-related medication and a suitable alternative is not available; current or past history of cancer; current or past history of vestibular pathology or cranial base surgery; craniofacial dysmorphology (examples: down syndrome, cleft palate); pregnancy or at risk and not using contraception; patulous Eustachian tube; non-patent nasal cavity; adenoids that block the Eustachian tube orifice; blood pressure greater than 140/90; had experimental drug or procedure in the previous 3 months; allergic to eggs, egg products, soy, or soy products; previously underwent balloon dilation of the Eustachian tube.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon dilation of the Eustachian tube<br>Insertion and inflation of balloon into Eustachian tube for up to 1 minute | Procedure: Balloon dilation of the Eustachian tube<br>* Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.<br>* Other names: Balloon tuboplasty;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eustachian tube function testing | opening pressure, closing pressure, passive resistance | 1 month post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eustachian tube function testing | opening pressure, closing pressure, passive resistance | 3 months post-operatively | 
| Eustachian tube function testing | opening pressure, closing pressure, passive resistance | 6 months post-operatively | 
| Eustachian tube function testing | opening pressure, closing pressure, passive resistance | 4 weeks after beginning medical treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otitis media, eustachian tube, eustachian tube dysfunction, eustachian tube function testing