Gastroesophageal RefluxNCT06329583
Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry
A study testing diaphragmatic breathing in people with Gastroesophageal Reflux and Dysphagia, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux, Dysphagia, Esophageal Motility Disorders
- What is being tested?
- diaphragmatic breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing high-resolution esophageal manometry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Pressures at the Esophagogastric Junction 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.
Read the 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.
- Being tested
- diaphragmatic breathing
- Medical subject headings
- Gastroesophageal Reflux, Deglutition Disorders, Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic breathingDiagnostic test
Different positions and techniques for diaphragmatic breathing
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing protocol | Other | All patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry. Receives: Diagnostic Test: diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure at the esophagogastric junction
Measurement of EGJ- contractile integral and diaphragmatic pressure with each exercise/instruction
Measured: Measured for each participant during high-resolution esophageal manometry. Data will be collected over the enrollment period of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 May 2024
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andree H. Koop, Mayo Clinic
- Investigators
- Andree Koop, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329583
- Sponsor's protocol ID
- 23-012635
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Pressures at the Esophagogastric Junction During Diaphragmatic Breathing Using High-resolution Esophageal Manometry
- ClinicalTrials.gov ID
- NCT06329583
- Acronym / sponsor ID
- 23-012635
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing protocol | Other | Diagnostic Test: diaphragmatic breathingAll patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing high-resolution esophageal manometry
Key exclusion criteria (7 listed)
- prior esophageal or gastric surgery
- chest tube
- major concomitant illness
- sinus disease precluding manometry placement
- history of heavy alcohol or tobacco use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragmatic breathingDifferent positions and techniques for diaphragmatic breathing | Diagnostic test | Diaphragmatic breathing protocol |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andree Koop, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic breathing in people with Gastroesophageal Reflux and Dysphagia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.