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This study aims to understand why patients have predominantly upright gastroesophageal reflux disease by comparing such patients to healthy persons AND whether a behavioral intervention (diaphragmatic breathing) will impact this disease
There are two major patterns of gastroesophageal reflux disease (GERD), predominantly daytime and upright reflux and predominantly nocturnal and supine reflux.
Traditionally, upright reflux has been attributed to more frequent or wider opening with transient lower esophageal sphincter relaxations (TLESRs) while supine reflux results from a consistently reduced lower esophageal sphincter (LES) pressure. This may further be accounted for by the finding of larger hiatal hernias and greater pressure gradients between the crura and LES when comparing supine to upright refluxers. These findings may help explain supine reflux, but they offer little insight into the mechanisms of upright reflux.
In this study the investigators will be recruiting twenty healthy persons and up to 60 patients with GERD will be recruited from the clinical practice at Mayo Clinic Rochester. The investigators aim to study the intervention on 40 patients with GERD. However, recognizing that up to 33% of patients with typical symptoms of GERD will not have reflux by ambulatory pH monitoring (pH power of hydration), the investigators provide for enrolling up to a maximum of 60 patients which should be sufficient to yield 40 patients with upright GERD by pH monitoring. In addition, up to 10 additional healthy persons may be recruited.
Subjects with upright reflux and healthy controls will be randomized into one of two groups:
Experimental: Diaphragmatic breathing or Sham comparator: (listening to music/watching Television (TV) for 30 minutes after each meal to see how this impacts the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diaphragmatic Breathing | Experimental | Subjects randomized to the experimental intervention arm will receive instructions and rationale for Diaphragmatic Breathing in the postprandial state and receive detailed instruction in diaphragmatic breathing. Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will practice diaphragmatic breathing for 30 minutes after each meal.
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| Life style counseling | Sham Comparator | Subjects randomized to the Sham Comparator intervention arm will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal) Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic Breathing | Behavioral | Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal. |
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| Measure | Description | Time Frame |
|---|---|---|
| The total esophageal acid exposure time during the diagnostic 24hour pH study compared with the interventional study | The investigators will compare the total esophageal acid exposure time in minutes during the first 24 hour ambulatory pH study with the second 24 period during which patients are either randomized to biofeedback versus sham | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Upper gastrointestinal pressures in patients with upright GER compared to healthy people | Upper gastrointestinal pressures and pressure changes associated with meals will be described. Pressure differences will be measured in mmHg. | 2 days |
| The effects of provocative maneuvers on upper gastrointestinal pressures. |
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Inclusion Criteria for Healthy Persons:
-Patients 18 years of age or older with no symptoms of GERD
Inclusion Criteria for Patients:
Exclusion Criteria for Patients; Items indicated with an asterisk (*) are also exclusion criteria for healthy persons
Exclusion Criteria for Healthy Persons in addition to those marked with an Asterisk (*) above
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Halland, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Sham Comparator | Behavioral | Sham therapy (listening to music/watching TV for 30 minutes after each meal |
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The investigators will compare the effects of provocative maneuvers on upper gastrointestinal pressure. Pressure differences will be measured in mmHg. |
| 2 days |
| The effects of provocative maneuvers on reflux | The investigators will compare the effects of provocative maneuvers on reflux as measured with impedance (Ohms) | 2 days |
| The effects of diaphragmatic breathing on upper gastrointestinal pressures | The investigators will report any pressure changes (measures in mmHg) associated with diaphragmatic breathing on upper gastrointestinal pressure. | 2 days |
| D004066 | Digestive System Diseases |