Back to resultsUnderstanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
Primary Purpose
GERD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diaphragmatic Breathing
Sham Comparator
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring Reflux
Eligibility Criteria
Inclusion Criteria for Healthy Persons:
-Patients 18 years of age or older with no symptoms of GERD
Inclusion Criteria for Patients:
- Patients 18 years of age or older with symptoms of GERD
- Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux
Exclusion Criteria for Patients; Items indicated with an asterisk (*) are also exclusion criteria for healthy persons
- Patient who fulfil ROME IV Criteria for rumination disorder20
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological (e.g., spinal cord injuries, dementia, multiple sclerosis, Parkinson's disease), psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
- Any prior gastric or esophageal surgery and significant intestinal or colonic resection*
- Hiatal hernia measuring 3 cm or larger as assessed by endoscopic or radiological studies
- Prior history of Los Angeles Grade C or D esophagitis, or esophageal stricture.
- Current use opioid analgesics or anticholinergic drugs.* We will permit low doses of tricyclic antidepressants, nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) provided they were commenced 3 months prior to the screening period, calcium channel or adrenergic1 antagonists
- Current use of proton pump inhibitors
- Known significant esophageal motor disorder (ie achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy *
- Pregnant and lactating females *
Exclusion Criteria for Healthy Persons in addition to those marked with an Asterisk (*) above
- Ongoing use of Proton Pump Inhibitors ( PPIs) or a history consistent with GE reflux for 3 months or longer duration in past.
- Prior history of Los Angeles Grade B-D esophagitis
- Prior history of GERD on the basis of pH testing
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Diaphragmatic Breathing
Life style counseling
Arm Description
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. During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal
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) During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
The effects of provocative maneuvers on upper gastrointestinal pressures.
The investigators will compare the effects of provocative maneuvers on upper gastrointestinal pressure. Pressure differences will be measured in mmHg.
The effects of provocative maneuvers on reflux
The investigators will compare the effects of provocative maneuvers on reflux as measured with impedance (Ohms)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02972047
Brief Title
Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
Official Title
Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diaphragmatic Breathing
Arm Type
Experimental
Arm Description
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.
During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker
After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal
Arm Title
Life style counseling
Arm Type
Sham Comparator
Arm Description
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)
During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker
After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic Breathing
Intervention Description
Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.
Intervention Type
Behavioral
Intervention Name(s)
Sham Comparator
Intervention Description
Sham therapy (listening to music/watching TV for 30 minutes after each meal
Primary Outcome Measure Information:
Title
The total esophageal acid exposure time during the diagnostic 24hour pH study compared with the interventional study
Description
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
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Upper gastrointestinal pressures in patients with upright GER compared to healthy people
Description
Upper gastrointestinal pressures and pressure changes associated with meals will be described. Pressure differences will be measured in mmHg.
Time Frame
2 days
Title
The effects of provocative maneuvers on upper gastrointestinal pressures.
Description
The investigators will compare the effects of provocative maneuvers on upper gastrointestinal pressure. Pressure differences will be measured in mmHg.
Time Frame
2 days
Title
The effects of provocative maneuvers on reflux
Description
The investigators will compare the effects of provocative maneuvers on reflux as measured with impedance (Ohms)
Time Frame
2 days
Title
The effects of diaphragmatic breathing on upper gastrointestinal pressures
Description
The investigators will report any pressure changes (measures in mmHg) associated with diaphragmatic breathing on upper gastrointestinal pressure.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Healthy Persons:
-Patients 18 years of age or older with no symptoms of GERD
Inclusion Criteria for Patients:
Patients 18 years of age or older with symptoms of GERD
Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux
Exclusion Criteria for Patients; Items indicated with an asterisk (*) are also exclusion criteria for healthy persons
Patient who fulfil ROME IV Criteria for rumination disorder20
Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological (e.g., spinal cord injuries, dementia, multiple sclerosis, Parkinson's disease), psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
Any prior gastric or esophageal surgery and significant intestinal or colonic resection*
Hiatal hernia measuring 3 cm or larger as assessed by endoscopic or radiological studies
Prior history of Los Angeles Grade C or D esophagitis, or esophageal stricture.
Current use opioid analgesics or anticholinergic drugs.* We will permit low doses of tricyclic antidepressants, nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) provided they were commenced 3 months prior to the screening period, calcium channel or adrenergic1 antagonists
Current use of proton pump inhibitors
Known significant esophageal motor disorder (ie achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy *
Pregnant and lactating females *
Exclusion Criteria for Healthy Persons in addition to those marked with an Asterisk (*) above
Ongoing use of Proton Pump Inhibitors ( PPIs) or a history consistent with GE reflux for 3 months or longer duration in past.
Prior history of Los Angeles Grade B-D esophagitis
Prior history of GERD on the basis of pH testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Halland, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
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