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NCT06329583 Clinical Trial

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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06329583
Other study ID # 23-012635
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2024
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• diaphragmatic breathing
Different positions and techniques for diaphragmatic breathing

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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