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OpenTrials
Completed

NCT Number: NCT06329583

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diaphragmatic breathing

Diagnostic Test

Different positions and techniques for diaphragmatic breathing

Primary outcomes

  1. Pressure at the esophagogastric junction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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