Eustachian Tube Dysfunction, Laryngopharyngeal Reflux
Conditions
Keywords
ear pressure, ear fullness, ear pain, ETD, laryngopharyngeal reflux, LPR, gastroesophageal reflux disease, GERD, nasopharyngeal reflux, acid reflux
Brief summary
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.
Interventions
DRUGOmeprazole
40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
DRUGRanitidine
300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
DRUGPantoprazole
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)
PROCEDURE24-Hour Diagnostic pH-Probe Test
Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
PROCEDURELaryngoscopy
Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain | 1 year | 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. |
Countries
United States
Outcome results
None listed