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

Not Applicable

Recruiting

• Conditions: Dysphagia; Gastroesophageal Reflux; Esophageal Motility Disorders
• Interventions: Diagnostic Test: diaphragmatic breathing

• Registration Number: NCT06329583
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

This is a prospective, single-center study of adult (age ≥18 years) participants undergoing high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing. Included patients will complete two validated surveys, the Brief Esophageal Dysphagia Questionnaire (BEDQ) and the Gastroesophageal Reflux Disease Questionnaire (GERDQ). Patients will then undergo a standard protocol of supine and upright swallows with high-resolution manometry analyzed according to the Chicago Classification v4.0. After completion of the standard manometry protocol, participants will then perform a protocol assessing different techniques and positions for diaphragmatic breathing.

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-24
• Study First Posted: 2024-03-26
• Study Start: 2024-05-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients undergoing high-resolution esophageal manometry

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diaphragmatic breathing protocol	diaphragmatic breathing	All patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry.

Primary Outcome Measures

Name	Time	Method
Pressure at the esophagogastric junction	Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.	Measurement of EGJ- contractile integral and diaphragmatic pressure with each exercise/instruction

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States