Clinical trial NCT02123498: The Study of Eustachian Tube Dysfunction and Laryngopharyngeal Reflux
Official title: The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Eustachian Tube Dysfunction
Laryngopharyngeal Reflux
Keywords: ear pressure
ear fullness
ear pain
ETD
laryngopharyngeal reflux
LPR
gastroesophageal reflux disease
GERD
nasopharyngeal reflux
acid reflux
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of laryngopharyngeal reflux in patients complaining of ear fullness/pressure/pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: 11234 Anderson Street
state: California
city: Redlands
country: United States
facility: 1895 Orange Tree Lane, Suite 102
state: California
Study officials:
affiliation: Loma Linda University Otolaryngology Department
name: Helen X Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbero GJ. Gastroesophageal reflux and upper airway disease. Otolaryngol Clin North Am. 1996 Feb;29(1):27-38.
citation: Crapko M, Kerschner JE, Syring M, Johnston N. Role of extra-esophageal reflux in chronic otitis media with effusion. Laryngoscope. 2007 Aug;117(8):1419-23. doi: 10.1097/MLG.0b013e318064f177.
citation: Heavner SB, Hardy SM, White DR, Prazma J, Pillsbury HC 3rd. Transient inflammation and dysfunction of the eustachian tube secondary to multiple exposures of simulated gastroesophageal refluxant. Ann Otol Rhinol Laryngol. 2001 Oct;110(10):928-34. doi: 10.1177/000348940111001007.
citation: Mims JW. The impact of extra-esophageal reflux upon diseases of the upper respiratory tract. Curr Opin Otolaryngol Head Neck Surg. 2008 Jun;16(3):242-6. doi: 10.1097/MOO.0b013e3282fdc3d6.
citation: Norman G, Llewellyn A, Harden M, Coatesworth A, Kimberling D, Schilder A, McDaid C. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. 2014 Feb;39(1):6-21. doi: 10.1111/coa.12220.
citation: Schreiber S, Garten D, Sudhoff H. Pathophysiological mechanisms of extraesophageal reflux in otolaryngeal disorders. Eur Arch Otorhinolaryngol. 2009 Jan;266(1):17-24. doi: 10.1007/s00405-008-0770-1. Epub 2008 Aug 13.
citation: Yazici ZM, Sari M, Uneri C, Midi A, Tugtepe H. Histologic changes in eustachian tube mucosa of rats after exposure to gastric reflux. Laryngoscope. 2008 May;118(5):849-53. doi: 10.1097/MLG.0b013e318164d0c0.