GERDNCT02972047
Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
A study testing Diaphragmatic Breathing in people with GERD, run by Mayo Clinic at 1 site in United States.
Trial summary
This study aims to understand why patients have predominantly upright gastroesophageal reflux disease by comparing such patients to healthy persons AND whether a behavioral intervention (diaphragmatic breathing) will impact this disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- Diaphragmatic Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 30 Aug 2020
- 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 18 years of age or older with no symptoms of GERD
- Patients 18 years of age or older with symptoms of GERD
- Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux
- Exclusion Criteria for Patients; Items indicated with an asterisk () are also exclusion criteria for healthy persons
- Patient who fulfil ROME IV Criteria for rumination disorder20
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological (e.g., spinal cord injuries, dementia, multiple sclerosis, Parkinson's disease), psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*
Show all 18Show fewer
- Any prior gastric or esophageal surgery and significant intestinal or colonic resection*
- Hiatal hernia measuring 3 cm or larger as assessed by endoscopic or radiological studies
- Prior history of Los Angeles Grade C or D esophagitis, or esophageal stricture.
- Current use opioid analgesics or anticholinergic drugs.* We will permit low doses of tricyclic antidepressants, nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) provided they were commenced 3 months prior to the screening period, calcium channel or adrenergic1 antagonists
- Current use of proton pump inhibitors
- Known significant esophageal motor disorder (ie achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy *
- Pregnant and lactating females *
- Exclusion Criteria for Healthy Persons in addition to those marked with an Asterisk () above
- Ongoing use of Proton Pump Inhibitors ( PPIs) or a history consistent with GE reflux for 3 months or longer duration in past.
- Prior history of Los Angeles Grade B-D esophagitis
- Prior history of GERD on the basis of pH testing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study aims to understand why patients have predominantly upright gastroesophageal reflux disease by comparing such patients to healthy persons AND whether a behavioral intervention (diaphragmatic breathing) will impact this disease
Read the detailed description
There are two major patterns of gastroesophageal reflux disease (GERD), predominantly daytime and upright reflux and predominantly nocturnal and supine reflux.
Traditionally, upright reflux has been attributed to more frequent or wider opening with transient lower esophageal sphincter relaxations (TLESRs) while supine reflux results from a consistently reduced lower esophageal sphincter (LES) pressure. This may further be accounted for by the finding of larger hiatal hernias and greater pressure gradients between the crura and LES when comparing supine to upright refluxers. These findings may help explain supine reflux, but they offer little insight into the mechanisms of upright reflux.
In this study the investigators will be recruiting twenty healthy persons and up to 60 patients with GERD will be recruited from the clinical practice at Mayo Clinic Rochester. The investigators aim to study the intervention on 40 patients with GERD. However, recognizing that up to 33% of patients with typical symptoms of GERD will not have reflux by ambulatory pH monitoring (pH power of hydration), the investigators provide for enrolling up to a maximum of 60 patients which should be sufficient to yield 40 patients with upright GERD by pH monitoring. In addition, up to 10 additional healthy persons may be recruited.
Subjects with upright reflux and healthy controls will be randomized into one of two groups:
Experimental: Diaphragmatic breathing or Sham comparator: (listening to music/watching Television (TV) for 30 minutes after each meal to see how this impacts the disease.
- Conditions
- GERD
- Being tested
- Diaphragmatic Breathing, Sham Comparator
- Keywords
- Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingBehavioural
Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.
Sham ComparatorBehavioural
Sham therapy (listening to music/watching TV for 30 minutes after each meal
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Subjects randomized to the experimental intervention arm will receive instructions and rationale for Diaphragmatic Breathing in the postprandial state and receive detailed instruction in diaphragmatic breathing.
Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will practice diaphragmatic breathing for 30 minutes after each meal.
1. During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker
2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal Receives: Behavioral: Diaphragmatic Breathing |
| Life style counseling | Sham comparator | Subjects randomized to the Sham Comparator intervention arm will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal)
Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal)
1. During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker
2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal Receives: Behavioral: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total esophageal acid exposure time during the diagnostic 24hour pH study compared with the interventional study
The investigators will compare the total esophageal acid exposure time in minutes during the first 24 hour ambulatory pH study with the second 24 period during which patients are either randomized to biofeedback versus sham
Measured: 2 days
Secondary outcomes (4)
Upper gastrointestinal pressures in patients with upright GER compared to healthy people
Upper gastrointestinal pressures and pressure changes associated with meals will be described. Pressure differences will be measured in mmHg.
Measured: 2 days
The effects of provocative maneuvers on upper gastrointestinal pressures.
The investigators will compare the effects of provocative maneuvers on upper gastrointestinal pressure. Pressure differences will be measured in mmHg.
Measured: 2 days
The effects of provocative maneuvers on reflux
The investigators will compare the effects of provocative maneuvers on reflux as measured with impedance (Ohms)
Measured: 2 days
The effects of diaphragmatic breathing on upper gastrointestinal pressures
The investigators will report any pressure changes (measures in mmHg) associated with diaphragmatic breathing on upper gastrointestinal pressure.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start6 Apr 2017
- Primary completion1 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Halland, Mayo Clinic
- Investigators
- Magnus Halland, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972047
- Sponsor's protocol ID
- 16-007005
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2016
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Pathophysiology and Effects of Diaphragmatic Breathing in Upright Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT02972047
- Acronym / sponsor ID
- 16-007005
- Conditions
- GERD
- Keywords
- Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 23 Nov 2016 (estimated)
- 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.
This study aims to understand why patients have predominantly upright gastroesophageal reflux disease by comparing such patients to healthy persons AND whether a behavioral intervention (diaphragmatic breathing) will impact this disease
Detailed description
There are two major patterns of gastroesophageal reflux disease (GERD), predominantly daytime and upright reflux and predominantly nocturnal and supine reflux.
Traditionally, upright reflux has been attributed to more frequent or wider opening with transient lower esophageal sphincter relaxations (TLESRs) while supine reflux results from a consistently reduced lower esophageal sphincter (LES) pressure. This may further be accounted for by the finding of larger hiatal hernias and greater pressure gradients between the crura and LES when comparing supine to upright refluxers. These findings may help explain supine reflux, but they offer little insight into the mechanisms of upright reflux.
In this study the investigators will be recruiting twenty healthy persons and up to 60 patients with GERD will be recruited from the clinical practice at Mayo Clinic Rochester. The investigators aim to study the intervention on 40 patients with GERD. However, recognizing that up to 33% of patients with typical symptoms of GERD will not have reflux by ambulatory pH monitoring (pH power of hydration), the investigators provide for enrolling up to a maximum of 60 patients which should be sufficient to yield 40 patients with upright GERD by pH monitoring. In addition, up to 10 additional healthy persons may be recruited.
Subjects with upright reflux and healthy controls will be randomized into one of two groups:
Experimental: Diaphragmatic breathing or Sham comparator: (listening to music/watching Television (TV) for 30 minutes after each meal to see how this impacts the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Behavioral: Diaphragmatic BreathingSubjects randomized to the experimental intervention arm will receive instructions and rationale for Diaphragmatic Breathing in the postprandial state and receive detailed instruction in diaphragmatic breathing. Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will practice diaphragmatic breathing for 30 minutes after each meal. 1. During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker 2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal |
| Life style counseling | Sham comparator | Behavioral: Sham ComparatorSubjects randomized to the Sham Comparator intervention arm will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal) Following the office visit the patients with upright GERD and healthy persons will undergo a further 24 hours of pH impedance monitoring. This group will will engage in sham therapy (listening to music/watching TV for 30 minutes after each meal) 1. During the second 24 hour period patients with GERD and healthy persons will again consume the standard pH neutral refluxogenic meal note this with an event marker 2. After 48 hours patients with GERD and healthy persons will present to the esophageal laboratory for probe removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- -Patients 18 years of age or older with no symptoms of GERD
- Patients 18 years of age or older with symptoms of GERD
- Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux
- Exclusion Criteria for Patients; Items indicated with an asterisk () are also exclusion criteria for healthy persons
- Patient who fulfil ROME IV Criteria for rumination disorder20
Key exclusion criteria (0 listed)
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 BreathingSubjects in this are practice diaphragmatic breathing for 30 minutes after each meal. | Behavioural | Diaphragmatic Breathing |
| Sham ComparatorSham therapy (listening to music/watching TV for 30 minutes after each meal | Behavioural | Life style counseling |
Primary outcome
The total esophageal acid exposure time during the diagnostic 24hour pH study compared with the interventional study
Time frame: 2 days
The investigators will compare the total esophageal acid exposure time in minutes during the first 24 hour ambulatory pH study with the second 24 period during which patients are either randomized to biofeedback versus sham
4 secondary outcomes
Upper gastrointestinal pressures in patients with upright GER compared to healthy people
Time frame: 2 days
The effects of provocative maneuvers on upper gastrointestinal pressures.
Time frame: 2 days
The effects of provocative maneuvers on reflux
Time frame: 2 days
The effects of diaphragmatic breathing on upper gastrointestinal pressures
Time frame: 2 days
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 4 Dec 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for GERD
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Magnus Halland, 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 GERD, 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 18 inclusion and 0 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 4 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
The total esophageal acid exposure time during the diagnostic 24hour pH study compared with the interventional study (time frame: 2 days). 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 4 Dec 2020.