Status:
COMPLETED
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
GERD
Larynx Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophagea...
Detailed Description
Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration...
Eligibility Criteria
Inclusion
- Male and female volunteers aged 18 to 65 years old.
- Control group: No known history of GERD or EERD or prior PPI use.
- GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
- EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.
Exclusion
- Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
- Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
- Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
- Expected non-compliance.
- Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
- Recent nasal surgery or nasal obstruction.
- Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
- Pregnancy
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00388453
Start Date
October 1 2006
End Date
July 1 2013
Last Update
June 27 2017
Active Locations (1)
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1
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232