Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry

NCT06329583 | Completed

• 1 other identifier: 23-012635
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

Conditions

Gastroesophageal Reflux; Dysphagia; Esophageal Motility Disorders

Outcome Measures

Primary Outcomes (1)

• Pressure at the esophagogastric junction

  Measurement of EGJ- contractile integral and diaphragmatic pressure with each exercise/instruction

  Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.

Study Arms (1)

Diaphragmatic breathing protocol

OTHER

All patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry.

Diagnostic Test: diaphragmatic breathing

Interventions

diaphragmatic breathing DIAGNOSTIC_TEST

Different positions and techniques for diaphragmatic breathing

Diaphragmatic breathing protocol

Eligibility Criteria

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

You may qualify if:

• patients undergoing high-resolution esophageal manometry

You may not qualify if:

• prior esophageal or gastric surgery
• chest tube
• major concomitant illness
• sinus disease precluding manometry placement
• history of heavy alcohol or tobacco use
• poor comprehension and/or fluency of English language
• inability or unwillingness of individual to give written informed consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroesophageal Reflux; Deglutition Disorders; Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Andree Koop, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 26, 2024
• Study Start: May 10, 2024
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)