Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults

NCT01251432 | Completed

• 2 other identifiers: PRO09040437P50DC007667
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research study measures how well the Eustachian tube works and looks directly at the anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted into their eardrums because they have been diagnosed as having either "otitis media" or "poor Eustachian tube function". The Eustachian tube is a biologic tube that connects the back of the nose to the middle ear (the airspace located behind your eardrum). That tube is usually closed, but can be opened by swallowing and other activities. Periodic openings of the Eustachian tube allow air to flow between the nose and middle ear which keeps the pressure of gas in the middle ear at the same level as that of the atmosphere, a condition required for good hearing. In children and adults, middle-ear diseases such as otitis media with effusion (the buildup of fluid within the middle ear) and a form of temporary hearing loss (conductive hearing loss) occur if the Eustachian tube does not open, does not open frequently enough or is always open (called a patulous Eustachian tube). A diagnosis of these different conditions can be made using standard, clinical tests of Eustachian tube function and the Eustachian tube can be visualized where it enters the back of the nose using a specialized telescope called an endoscope. Some scientific reports suggest that the cause of poor Eustachian tube function in an individual can be determined by studying the anatomy of the Eustachian tube at the back of the nose and the movements of the Eustachian tube in that area during swallowing, talking and other activities using an endoscope. In this study, the investigators plan to explore the relationship between the results of the standard Eustachian tube function tests and those for the anatomy and function of the Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian tube function. Also, there are a number other disease conditions (examples: nasal allergy, acid reflux disease) that are related to poor Eustachian tube function and it is possible that these conditions and their effect on Eustachian tube function can be treated with medicines. Therefore, the investigators also plan to evaluate enrolled persons for those conditions. It is expected that if the results of the standard Eustachian tube function tests can be explained by the anatomy of the back of the nose and Eustachian tube, the functional anatomy (movements during swallowing etc) of the Eustachian tube or the presence of allergy and or/acid reflux disease, new medical and/or surgical treatments can be developed to improve Eustachian tube function and "cure" or treat the associated middle-ear diseases.

Conditions

Eustachian Tube Dysfunction; Chronic Otitis Media

Keywords

otitis media; Eustachian tube; allergy; gastroesophageal reflux; tympanostomy tube

Outcome Measures

Primary Outcomes (1)

• Eustachian tube function

  manometric tests of ET function

  Visit 1

Secondary Outcomes (1)

• results of videoendoscopic exam

  Visit 1

Other Outcomes (2)

• serum IgE titer

  Visit 1

• GERD survey

  Visit 1

Study Arms (2)

chronic otitis media

adults who have had tympanostomy tube(s) inserted for chronic otitis media

Eustachian tube dysfunction

adults who have had tympanostomy tube(s) inserted for the clinical diagnosis of Eustachian tube dysfunction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with tympanostomy tube(s) for chronic otitis media and/or eustachian tube dysfunction

You may qualify if:

• years of age and older
• at least one functioning tympanostomy tube

You may not qualify if:

• any diagnosed cancer
• otitis onset attributable to barotrauma (eg, hyperbaric oxygen treatment)
• known vestibular/inner ear pathology who may incur dizzy or vertigo symptoms as a result of increase in middle ear pressure
• history of ossicular chain reconstruction
• known hypersensitivity to topical medicines (lidocaine, oxymetazoline)
• severe nasal obstruction

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Middle Ear Physiology Laboratory, Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Otitis Media; Hypersensitivity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Cuneyt M Alper, MD

  Department of Otolaryngology, University of Pittsburgh School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

US (1)