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

NCT02972047 | Completed

• 1 other identifier: 16-007005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

GERD

Keywords

Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Upper gastrointestinal pressures in patients with upright GER compared to healthy people

  2 days

• The effects of provocative maneuvers on upper gastrointestinal pressures.

  2 days

• The effects of provocative maneuvers on reflux

  2 days

• The effects of diaphragmatic breathing on upper gastrointestinal pressures

  2 days

Study Arms (2)

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. 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

Behavioral: Diaphragmatic Breathing

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) 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

Behavioral: Sham Comparator

Interventions

Diaphragmatic Breathing BEHAVIORAL

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

Diaphragmatic Breathing

Sham Comparator BEHAVIORAL

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

Life style counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Magnus Halland, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: April 6, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 30, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)