Recruitment

Recruitment Status
Completed
Estimated Enrollment
80

Inclusion Criterias

otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
history of Eustachian tube dysfunction and/or otitis media with effusion;
BMI of less than 35;
...
otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
history of Eustachian tube dysfunction and/or otitis media with effusion;
BMI of less than 35;
has functional ventilation tube or a chronic perforation in at least one ear;
history of middle-ear effusion at least once;
no known family history of malignant hyperthermia.
no history of difficult intubation;

Exclusion Criterias

pregnancy or "at risk" and not using contraception;
patulous Eustachian tube;
adenoids that block the Eustachian tube orifice;
...
pregnancy or "at risk" and not using contraception;
patulous Eustachian tube;
adenoids that block the Eustachian tube orifice;
previously underwent balloon dilation of the Eustachian tube.
history of adverse reaction to any study-related medication and a suitable alternative is not available;
non-patent nasal cavity;
current or past history of vestibular pathology or cranial base surgery;
blood pressure greater than 140/90;
current or past history of cancer;
allergic to eggs, egg products, soy, or soy products;
had experimental drug or procedure in the previous 3 months;
craniofacial dysmorphology (examples: down syndrome, cleft palate);

Summary

Conditions
Eustachian Tube Dysfunction
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Both males and females

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 be...

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.

Inclusion Criterias

otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
history of Eustachian tube dysfunction and/or otitis media with effusion;
BMI of less than 35;
...
otherwise healthy except for possible gastro-esophageal reflux disease (GERD), allergies, sinusitis;
history of Eustachian tube dysfunction and/or otitis media with effusion;
BMI of less than 35;
has functional ventilation tube or a chronic perforation in at least one ear;
history of middle-ear effusion at least once;
no known family history of malignant hyperthermia.
no history of difficult intubation;

Exclusion Criterias

pregnancy or "at risk" and not using contraception;
patulous Eustachian tube;
adenoids that block the Eustachian tube orifice;
...
pregnancy or "at risk" and not using contraception;
patulous Eustachian tube;
adenoids that block the Eustachian tube orifice;
previously underwent balloon dilation of the Eustachian tube.
history of adverse reaction to any study-related medication and a suitable alternative is not available;
non-patent nasal cavity;
current or past history of vestibular pathology or cranial base surgery;
blood pressure greater than 140/90;
current or past history of cancer;
allergic to eggs, egg products, soy, or soy products;
had experimental drug or procedure in the previous 3 months;
craniofacial dysmorphology (examples: down syndrome, cleft palate);

Locations

Pittsburgh, Pennsylvania, 15213
Pittsburgh, Pennsylvania, 15213

Tracking Information

NCT #
NCT02114762
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
  • Principal Investigator: Cuneyt M Alper, MD University of Pittsburgh
  • Cuneyt M Alper, MD University of Pittsburgh