Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT02972047
Sponsor Protocol Number: 16-007005
About this study
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
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Healthy Persons:
- Patients 18 years of age or older with no symptoms of GERD
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:
Patients; Items indicated with an asterisk (*) are also exclusion criteria for healthy persons
- Patient who fulfil ROME IV Criteria for rumination disorder²°
- 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 *
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
More information
Publications
Publications are currently not available