Diaphragmatic Breathing for Esophageal Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Esophageal surgery, Gastric surgery, Major illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of diaphragmatic breathing as a treatment for esophageal disorders?

Research shows that diaphragmatic breathing can help reduce symptoms of gastroesophageal reflux disease (GERD), such as belching and reflux, by strengthening the muscles around the lower esophageal sphincter (LES), which helps prevent stomach acid from moving back up into the esophagus. ^{1 2 3 4 5}

Is diaphragmatic breathing safe for humans?

The provided research articles do not contain relevant safety information about diaphragmatic breathing or its related terms for esophageal disorders or other conditions. ^{6 7 8 9 10}

How does diaphragmatic breathing differ from other treatments for esophageal disorders?

Diaphragmatic breathing is a unique treatment for esophageal disorders because it focuses on using deep breathing techniques to help manage symptoms, rather than relying on medications or surgical procedures. This approach may help improve esophageal function by promoting relaxation and reducing stress, which can be beneficial for conditions like achalasia where traditional treatments aim to reduce pressure in the esophagus. ^{8 11 12 13 14}

Research Team

Andree Koop, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients who are already scheduled to undergo high-resolution esophageal manometry, a test that measures muscle contractions in the esophagus. It's aimed at those with conditions like acid reflux or difficulty swallowing.

Inclusion Criteria

I am scheduled for or have had a detailed esophagus muscle test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Manometry Assessment

Participants undergo high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing

1 session

1 visit (in-person)

Diaphragmatic Breathing Protocol

Participants perform a protocol assessing different techniques and positions for diaphragmatic breathing

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the manometry assessment

4 weeks

Treatment Details

Interventions

• Diaphragmatic Breathing

Trial Overview The study is testing how diaphragmatic breathing affects pressure at the EGJ (the valve between the esophagus and stomach). Researchers want to find out which positions or maneuvers increase this pressure most effectively.

Participant Groups

Group I: Diaphragmatic breathing protocol Experimental Treatment 1 Intervention

All patients will undergo the diaphragmatic breathing protocol with high-resolution esophageal manometry.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Diaphragmatic Breathing on the Pathophysiology and Treatment of Upright Gastroesophageal Reflux: A Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Comorbidity of aerophagia in GERD patients: outcome of laparoscopic antireflux surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pneumatic dilatation for achalasia after fundoplication. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Diaphragmatic Breathing Reduces Belching and Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events during and after per-oral endoscopic myotomy: prevention, diagnosis, and management. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Clinical impact of routine CT esophagogram after peroral endoscopic myotomy (POEM) for esophageal motility disorders. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Idiopathic (primary) achalasia. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Anesthetic Consideration for Peroral Endoscopic Myotomy. [2020]

11. Serbia pubmed.ncbi.nlm.nih.gov

"Stray" achalasia: From gastroenterologist to pulmonologist and back. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Initial experience with peroral endoscopic myotomy for treatment of achalasia in children. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

[Esophageal Motility Disorders - What's New?] [2023]

14. England pubmed.ncbi.nlm.nih.gov

Functional esophageal disorders: a review of diagnosis and management. [2022]