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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 esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.
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, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Healthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use |
|
| 2 | Experimental | subject is known to have GERD based on symptoms and previous positive response to PPI |
|
| 3 | Experimental | subject is known to have EERD based on symptoms and previous positive response to PPI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dx-pH Probe | Device | 24 hour ph monitoring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in pH From Baseline to <4 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. | 24 hours |
| Decrease in pH From Baseline to <5 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. | 24 hours |
| Decrease in pH From Baseline to <6 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Reflux Events | Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F Vaezi, MD, PhD, MS | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
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Volunteers for all three groups were recruited from the Vanderbilt Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers With no History of GERD or EERD or PPI Use | Healthy volunteers with no history of GERD or EERD or PPI use Dx-pH Probe: 24 hour ph monitoring Manometry: procedure to measure LES and UES |
| FG001 | Volunteers With History of Gastroesophageal Reflux Disease | Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy. |
| FG002 | Volunteers With Laryngopharangeal Reflux (LPR) | Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Male and female normal volunteers who had no LPR symptoms or known history of GERD.
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers With no History of GERD or EERD or PPI Use | Healthy volunteers with no history of GERD or EERD or PPI use Dx-pH Probe: 24 hour ph monitoring Manometry: procedure to measure LES and UES |
| BG001 | Volunteers With Gastroesophageal Reflux Disaese (GERD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in pH From Baseline to <4 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. | Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. | Posted | Median | Inter-Quartile Range | distal esophagus total % time pH <4 | 24 hours |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers With no History of GERD or EERD or PPI Use | Healthy volunteers with no history of GERD or EERD or PPI use Dx-pH Probe: 24 hour ph monitoring Manometry: procedure to measure LES and UES |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Gastrointestinal disorders | Systematic Assessment | One patient reported a single episode of cough during the study. |
Lack of prior validation studies on appropriate positioning of the oropharyngeal pH probe.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Vaezi, MD, PhD | Vanderbilt University | 615.322.3739 | michael.vaezi@vanderbilt.edu |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D008365 | Manometry |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Manometry |
| Procedure |
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES) |
|
| 24 hours |
History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy |
| BG002 | Volunteers With Laryngopharangeal Reflux (LPR) | Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES
| OG001 | Volunteers With History of Gastroesophageal Reflux Disease | GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month with an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy. |
| OG002 | Volunteers With Laryngopharangeal Reflux (LPR) | Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness. |
|
|
|
| Primary | Decrease in pH From Baseline to <5 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. | Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. | Posted | Median | Inter-Quartile Range | distal esophagus total % time pH <5 | 24 hours |
|
|
|
| Primary | Decrease in pH From Baseline to <6 | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. | Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either <4, or <5, or <6 and each event had to last more than 5 seconds and could not be during the meals. | Posted | Median | Inter-Quartile Range | distal esophagus total % time pH <6 | 24 hours |
|
|
|
| Secondary | Number of Reflux Events | Reflux event was calculated for a drop in pH from baseline to <6 and each event had to last more than 5 seconds and could not be during the meals. | Posted | Median | Inter-Quartile Range | reflux events | 24 hours |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Volunteers With Gastroesphageal Reflux Disease (GERD) | GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at time of endoscopy. | 0 | 17 | 0 | 17 |
| EG002 | Volunteers With Laryngopharangeal Reflux (LPR) | Suspected to have reflux-related laryngeal symptoms including chronic cough and hoarseness. | 0 | 10 | 0 | 10 |
|
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| D004066 | Digestive System Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |