The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux

Study Overview
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Brief Summary
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The purpose of this study is to investigate the relationship between ear fullness, pressure, and/or pain and laryngopharyngeal reflux, in order to focus medical therapy and improve therapeutic outcomes in this patient population.

Official Title
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The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)

Conditions
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Eustachian Tube Dysfunction, Laryngopharyngeal Reflux

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Ranitidine
* Drug: Pantoprazole
* Procedure: 24-Hour Diagnostic pH-Probe Test
* Procedure: Laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They complain of symptoms of ear fullness, ear pain, and/or ear pressure, either unilateral or bilateral They are willing to participate in the study. They are between the ages of 18 to 80 Exclusion Criteria: They have had major ear surgery (not including tympanostomy tubes) They have a medical condition that is another possible etiology of ear pain or acid reflux and may require additional medical or surgical intervention such as: Acute or chronic otitis externa, Chronic otitis media, Temporomandibular joint dysfunction, Upper aerodigestive track neoplasm, History of head/neck radiation therapy. They are pregnant. Proton pump inhibitors are a Category C drug with unknown pregnancy risks. They do not wish to participate in the study They are <18 or >80.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: Omeprazole<br>* 40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks<br>* Other names: Prilosec;Drug: Ranitidine<br>* 300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks<br>* Other names: Zantac;Drug: Pantoprazole<br>* 40mg, to be taken twice daily by mouth, 30-60 minutes before meals, for at least 6 weeks. (Alternative intervention if participant cannot tolerate omeprazole, is on an anticoagulant medication, or if on medication contraindicated for omeprazole and ranitidine)<br>* Other names: Protonix;Procedure: 24-Hour Diagnostic pH-Probe Test<br>* Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.<br>Procedure: Laryngoscopy<br>* Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain | Participants complaining of ear pain, ear fullness, or ear pain are diagnosed with laryngopharyngeal reflux via laryngoscope exam and measurement by diagnostic pH-probe test. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD, nasopharyngeal reflux, acid reflux