Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321503
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2006-05-02
Brief Title:
Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux LPR
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Diagnosis and Response to Treatment of Laryngopharyngeal Reflux Using an Oropharyngeal Aerosolized pH Probe
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a test of how well a new FDA-approved device is for diagnosing a condition known as laryngopharyngeal reflux LPR The device which measures pH of the air in the upper throat will be compared to several other methods for diagnosing laryngopharyngeal reflux
Detailed Description:
It is estimated that up to 50 of patients with voice disorders and 4-10 of patients seen in otolaryngology practice experience laryngopharyngeal reflux LPR LPR has been implicated in the pathogenesis of numerous laryngeal disorders including subglottic stenosis laryngeal carcinoma laryngeal contact ulcers laryngospasm and vocal cord nodules In the pediatric population it has been associated with asthma sinusitis and otitis media Common symptoms include chronic and intermittent hoarseness vocal fatigue globus pharyngeus cough postnasal drip chronic throat clearing and dysphagia
Like gastroesophageal reflux disease GERD the etiology of LPR is linked to esophageal sphincter dysfunction In GERD the lower esophageal sphincter LES is involved whereas in LPR the pathology results from upper esophageal sphincter UES dysfunction However diagnosis of LPR is more challenging than that of GERD The classic reflux-like symptoms of heartburn and regurgitation are often absent in LPR
The most widely used diagnostic modality for LPR is symptomatic response to treatment including twice daily proton pump inhibitor PPI or H2 blocker therapy for several months However the use of a therapeutic modality to make a diagnosis clearly carries disadvantages including potentially unnecessary exposure to a drugs side effect profile and lengthy time to diagnosis Another diagnostic instrument is the reflux symptom index RSI a validated nine-item questionnaire assessing LPR symptoms However LPR symptoms are fairly nonspecific also appearing in autoimmune and behavior disorders Lastly a 24-hour triple-pH probe may be the best objective test diagnosing LPR However this method is poorly tolerated by patients and difficulty with ease of administration limits its routine use To date we have remained in search of a minimally invasive and specific test for LPR
In this study we will investigate the use of a newly developed oropharyngeal pH probe for detecting aerosolized acid as an accurate and minimally invasive diagnostic instrument for LPR This device has previously been shown to correlate to lower esophageal upper esophageal and lower pharyngeal pH as measured by a 24-hour triple channel bifurcated pH probe ACG Poster session by Dr G Wiener The number of oropharyngeal aerosolized acid reflux events and acid exposure times will be compared to RSI before and after twice daily proton pump inhibitor therapy In addition the correlation between acid reflux events and acid exposure times as measured by the Dx probe will be more rigorously compared to that measured by a triple pH probe
Like gastroesophageal reflux disease GERD the etiology of LPR is linked to esophageal sphincter dysfunction In GERD the lower esophageal sphincter LES is involved whereas in LPR the pathology results from upper esophageal sphincter UES dysfunction However diagnosis of LPR is more challenging than that of GERD The classic reflux-like symptoms of heartburn and regurgitation are often absent in LPR
The most widely used diagnostic modality for LPR is symptomatic response to treatment including twice daily proton pump inhibitor PPI or H2 blocker therapy for several months However the use of a therapeutic modality to make a diagnosis clearly carries disadvantages including potentially unnecessary exposure to a drugs side effect profile and lengthy time to diagnosis Another diagnostic instrument is the reflux symptom index RSI a validated nine-item questionnaire assessing LPR symptoms However LPR symptoms are fairly nonspecific also appearing in autoimmune and behavior disorders Lastly a 24-hour triple-pH probe may be the best objective test diagnosing LPR However this method is poorly tolerated by patients and difficulty with ease of administration limits its routine use To date we have remained in search of a minimally invasive and specific test for LPR
In this study we will investigate the use of a newly developed oropharyngeal pH probe for detecting aerosolized acid as an accurate and minimally invasive diagnostic instrument for LPR This device has previously been shown to correlate to lower esophageal upper esophageal and lower pharyngeal pH as measured by a 24-hour triple channel bifurcated pH probe ACG Poster session by Dr G Wiener The number of oropharyngeal aerosolized acid reflux events and acid exposure times will be compared to RSI before and after twice daily proton pump inhibitor therapy In addition the correlation between acid reflux events and acid exposure times as measured by the Dx probe will be more rigorously compared to that measured by a triple pH probe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DX-1 for LPR | OTHER | other | None |