Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux

NCT ID: NCT02972047

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-06
• Study Completion Date: 2020-08-30

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.

Conditions

GERD

Keywords

Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diaphragmatic Breathing

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.

1. 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

2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal

Group Type: EXPERIMENTAL

Diaphragmatic Breathing

Intervention Type: BEHAVIORAL

Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.

Life style counseling

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)

1. 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

2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: BEHAVIORAL

Sham therapy (listening to music/watching TV for 30 minutes after each meal

Interventions

Diaphragmatic Breathing

Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.

Intervention Type: BEHAVIORAL

Sham Comparator

Sham therapy (listening to music/watching TV for 30 minutes after each meal

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-Patients 18 years of age or older with no symptoms of GERD

• 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

• 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 *

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Magnus Halland

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Halland, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-007005

Identifier Type: -

Identifier Source: org_study_id