Eustachian Tube Dysfunction | The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
Eustachian Tube Dysfunction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Eustachian Tube Dysfunction
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Omeprazole40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
Drug:Ranitidine300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
Drug:Pantoprazole40mg, 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)
Procedure:24-Hour Diagnostic pH-Probe TestParticipants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
Procedure:LaryngoscopyParticipants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Phase: Phase 4
Primary Outcome: Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
Study sponsors, principal investigator, and references
Principal Investigator: Helen X Xu, MD
Lead Sponsor: Loma Linda University
Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.