Shaker Pressure Band for GERD

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Sleep apnea, Head/neck surgery, Carotid disease, others

Compensation: Varies

Number of Visits: 2

Duration: 1 week

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Shaker Pressure Band, designed to reduce nighttime symptoms of acid reflux, such as coughing, choking, and regurgitation. The goal is to determine if this band can improve nighttime comfort for people with GERD (gastroesophageal reflux disease). Participants will use either the active band or a non-active version to compare effects. Individuals with GERD who experience throat-related issues might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance nighttime comfort for GERD sufferers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for GERD patients?

Research shows that the Shaker Pressure Band aims to help with severe reflux symptoms that don't improve with other treatments. Although specific safety data from past studies is lacking, the current trial is assessing the device's safety and effectiveness. Thus, its safety profile is not yet fully known.

In other studies, similar devices applying pressure to the esophagus have been used alongside common treatments like medications that reduce stomach acid. These studies primarily evaluated the devices' effectiveness and did not identify major safety issues. This suggests that the Shaker Pressure Band might be safe, but further research is necessary to confirm this.

Because detailed safety information is unavailable, unknown risks may exist. Anyone considering joining this trial should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard GERD treatments that typically involve medications like proton pump inhibitors or lifestyle changes, the Shaker Pressure Band takes a different approach. This innovative device applies external laryngeal pressure, which is thought to help reduce symptoms by physically supporting the structures involved in reflux. Researchers are excited about this method because it offers a non-drug alternative that could provide relief without the potential side effects of medications. Additionally, this treatment could show results in just a week, offering a quick and convenient option for patients.

What evidence suggests that the Shaker Pressure Band is effective for GERD?

Research shows that the Shaker Pressure Band can help reduce nighttime symptoms of GERD, a condition where stomach acid flows back into the esophagus. In this trial, participants will join one of two groups: one will use the Shaker Pressure Band with external laryngeal pressure, while the other will use a sham Shaker Pressure Band without it. Previous studies have shown that similar devices, when used with proton pump inhibitors (PPIs), significantly improved symptoms. Specifically, another study found that a device similar to the Shaker Pressure Band, which compresses the upper esophagus, was effective with PPIs for patients with laryngopharyngeal reflux (LPR), a type of GERD affecting the throat. These findings suggest that the Shaker Pressure Band could benefit those dealing with nighttime reflux symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults aged 18 or older with GERD and related ear, nose, throat symptoms, chronic cough, choking, or regurgitation can join. They must not be pregnant or breastfeeding and have no history of head/neck surgery or radiation. Excluded are those under 18 or over 85, with sleep apnea (on CPAP), carotid artery/thyroid/cerebral vascular disease, bleeding disorders preventing nasal intubation, or esophageal obstruction.

Inclusion Criteria

You are not pregnant or breastfeeding.

You have GERD and experience symptoms such as chronic cough, choking, or food coming back up into your throat.

Patients with gastroesophageal reflux disease (GERD) who has ear, nose, and throat symptoms, chronic cough, choking, or regurgitation (food coming back up into the throat)

Exclusion Criteria

Patient cannot have previous head or neck surgery or radiation

The patient cannot have sleep apnea or be on CPAP

Patient cannot have carotid artery disease, thyroid disease or history of cerebral vascular disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the Shaker pressure band or a sham band for one week

1 week

1 visit (in-person) for band fitting and assessment

Follow-up

Participants are monitored for changes in symptoms after treatment

1 week

1 visit (in-person) for symptom evaluation

What Are the Treatments Tested in This Trial?

Interventions

• Shaker Pressure Band

Trial Overview

The trial is testing the Shaker Pressure Band's effectiveness in reducing nighttime symptoms caused by acid reflux into the pharynx. It aims to see if this external upper esophageal band can provide relief for patients suffering from GERD-related discomfort at night.

How Is the Trial Designed?

Group I: Shaker Pressure Band GERD patients with external laryngeal pressure Active Control 1 Intervention

One week of Shaker pressure band

Group II: Shaker Pressure Band GERD patients without external laryngeal pressure Placebo Group 1 Intervention

One week of sham Shaker pressure band (no external laryngeal pressure)

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a study of 5796 patients with gastro-oesophageal reflux disease (GERD), approximately 14-20% experienced a partial response to proton pump inhibitors (PPIs), indicating that while PPIs are effective for many, some patients still have significant heartburn symptoms.

Partial heartburn response was more common in patients with non-erosive reflux disease (19.9%) compared to those with reflux oesophagitis (14.0%), suggesting that the type of reflux disease may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial symptom-response to proton pump inhibitors in patients with non-erosive reflux disease or reflux oesophagitis - a post hoc analysis of 5796 patients. Bytzer, P., van Zanten, SV., Mattsson, H., et al.[2022]

In a study of 43 morbidly obese patients, it was found that those with gastro-esophageal reflux disease (GERD) had significantly higher acid exposure and lower Lower Esophageal Sphincter (LES) pressure compared to non-obese controls.

After laparoscopic adjustable gastric band (LAGB) placement, most patients experienced a significant reduction in esophageal acid exposure, indicating that LAGB can effectively alleviate GERD symptoms in obese patients, although some patients with gastric pouch dilation did not benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal esophageal acid exposure is common in morbidly obese patients and improves after a successful Lap-band system implantation. Iovino, P., Angrisani, L., Tremolaterra, F., et al.[2015]

Lifestyle factors like obesity, smoking, and alcohol consumption are linked to worsening gastroesophageal reflux disease (GERD), as they can lower the pressure of the lower esophageal sphincter (LES).

Despite the known impact of these lifestyle choices, clinical studies show mixed results regarding their direct relationship with GERD, suggesting that more research is needed to clarify these connections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle modification as a medical treatment for GERD]. Kurosawa, S.[2011]

In a study of 274 morbidly obese patients, 16% had significant GERD symptoms requiring treatment before undergoing Lap-Band surgery, highlighting the high prevalence of GERD in this population.

Post-surgery, 76% of patients experienced complete resolution of their reflux symptoms, suggesting that Lap-Band placement may effectively reduce GERD symptoms, contrary to some reports that suggest gastric banding worsens reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroesophageal reflux in obesity: the effect of lap-band placement. Dixon, JB., O'Brien, PE.[2013]

The magnetic device for augmenting lower esophageal sphincter function in GERD patients showed significant and sustained improvement in reflux control over 5 years, with GERD-related quality of life scores decreasing from a median of 27 to 4.

There were no device-related complications such as erosions or malfunctions, and the need for proton pump inhibitors dropped from 100% of patients at baseline to only 15.3% after 5 years, indicating both safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Ganz, RA., Edmundowicz, SA., Taiganides, PA., et al.[2022]

In a clinical trial with 31 participants, the Reflux Band device, when used alongside proton pump inhibitors (PPIs), significantly improved symptoms of laryngopharyngeal reflux (LPR), with 55% of participants meeting the primary endpoint after 4 weeks of combined treatment.

The study found that the mean reflux symptom index (RSI) score significantly decreased from 21.9 after PPI alone to 15.5 after using the Reflux Band with PPI, indicating enhanced efficacy of the device in reducing reflux symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Yadlapati, R., Pandolfino, JE., Greytak, M., et al.[2022]

The North American Society for Pediatric Gastroenterology and Nutrition has developed a clinical practice guideline for managing gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) in children, based on a thorough review of medical literature and expert consensus.

The guideline outlines evaluation, initial treatment, follow-up management, and when to refer to specialists, providing a comprehensive framework for primary care providers and pediatric gastroenterologists to address GERD effectively in infants and older children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: recommendations of the North American Society for Pediatric Gastroenterology and Nutrition. Rudolph, CD., Mazur, LJ., Liptak, GS., et al.[2022]

In a meta-analysis of 14 randomized controlled trials involving 771 participants, proton pump inhibitor (PPI) therapy was found to significantly improve reflux symptoms in patients with laryngopharyngeal reflux (LPR) compared to placebo, with a risk difference of 0.15.

While PPI therapy improved the total reflux symptom index, it did not show any significant advantage over placebo in improving the reflux finding score, indicating that while symptoms may improve, some clinical findings may not reflect this change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitor Therapy for the Treatment of Laryngopharyngeal Reflux: A Meta-Analysis of Randomized Controlled Trials. Guo, H., Ma, H., Wang, J.[2016]

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Even refractory atypical GERD symptoms may improve, with nearly three-fourths of patients off PPI therapy at 12-month follow-up. Long-term efficacy data ...

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The Lyon Consensus evaluated GERD diagnostic tests from that perspective, and test results were categorised as being adequate to establish or refute a GERD ...