NCT02972047

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Diaphragmatic Breathing	Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.
BEHAVIORAL	Sham Comparator	Sham therapy (listening to music/watching TV for 30 minutes after each meal

Timeline

• Start date: 2017-04-06
• Primary completion: 2020-08-01
• Completion: 2020-08-30
• First posted: 2016-11-23
• Last updated: 2020-12-04

Locations

1 site across 1 country: United States