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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06329583
Enrollment
13
Registered
2024-03-26
Start date
2024-05-10
Completion date
2026-04-02
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Esophageal Motility Disorders, Gastroesophageal Reflux

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.

Interventions

DIAGNOSTIC_TESTdiaphragmatic breathing

Different positions and techniques for diaphragmatic breathing

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure at the esophagogastric junctionMeasured 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndree Koop, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026