What is the mechanism of action of this treatment?

Common treatments for Laryngopharyngeal Reflux (LPR) include proton pump inhibitors (PPIs) and external compression devices like the Reflux Band. PPIs reduce stomach acid production, which helps minimize acid reflux into the larynx and pharynx, alleviating symptoms such as throat irritation and chronic cough. The Reflux Band works by applying external pressure to the upper esophageal sphincter (UES), enhancing its barrier function to prevent acid reflux. This mechanical approach is particularly beneficial for LPR patients who do not respond adequately to acid-suppressing medications alone.

What side effects are associated with this type of intervention?

Common treatments for Laryngopharyngeal Reflux (LPR) include Proton Pump Inhibitors (PPIs) and devices like the Reflux Band, which applies external compression to the upper esophageal sphincter. PPIs are generally well-tolerated but can cause side effects such as headache, diarrhea, constipation, nausea, and abdominal pain. Long-term use of PPIs may be associated with an increased risk of fractures, kidney disease, and vitamin B12 deficiency. The Reflux Band, which is designed to prevent reflux by compressing the upper esophageal sphincter, may cause discomfort, skin irritation, or pressure-related issues at the site of application. Further studies are needed to fully understand the long-term safety and efficacy of such devices.

What prior FDA approvals exist?

The Reflux Band, an external upper esophageal sphincter compression device, is currently being studied for its efficacy in treating Laryngopharyngeal Reflux (LPR). While the context does not provide specific information on prior FDA approvals for similar devices, treatments for LPR generally include proton pump inhibitors (PPIs) and other acid-suppressing medications, which have been widely used and approved for managing reflux-related conditions. These medications aim to reduce acid production and alleviate symptoms associated with LPR.

What other types of research exist?

Promising novel alternatives to the Reflux Band for Laryngopharyngeal Reflux patients include: 1) Radiofrequency Ablation (RFA), which has shown safety and efficacy in treating GERD, potentially applicable to LPR. 2) Personalized treatment plans based on multichannel intraluminal impedance-pH monitoring, which tailor therapy according to the type of reflux (acid, non-acid, mixed). 3) Acupuncture, which has been compared favorably to increased doses of proton pump inhibitors in refractory heartburn cases and may offer benefits for LPR.

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Behavioural Intervention

Reflux Band for Acid Reflux

N/A

Recruiting

Led By Rena Yadlapati, MD, MSHS

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current use of double daily dose acid suppression therapy (ex. omeprazole 40mg, omeprazole 20mg and famotidine 20mg)

Be older than 18 years old

Must not have

Patients with carotid artery disease, uncontrolled thyroid disease, a history of cerebrovascular disease, or connective tissue disorder of Marfan's Syndrome or Ehlers-Danlos Syndrome

Patients diagnosed with glaucoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Summary

This trial tests if a special neck band can help people with throat issues caused by stomach acid. The band is worn at night and works by increasing pressure on a muscle to stop acid from reaching the throat.

Who is the study for?

This trial is for adults aged 18-99 with laryngopharyngeal reflux confirmed by tests, who have been on double dose acid suppression therapy. They must not have had neck cancer/surgery, use certain night-time breathing aids, or have specific conditions like glaucoma or a history of foregut surgery. Pregnant/breastfeeding individuals and those unable to consent in English/Spanish are excluded.

What is being tested?

The study compares an external device that compresses the upper esophageal sphincter (Reflux Band) against a sham device over 12 weeks to see if it reduces symptoms of acid reflux more effectively. Participants will be randomly assigned to either the real treatment or placebo without knowing which one they receive.

What are the potential side effects?

Potential side effects may include discomfort at the site where the Reflux Band is applied, possible interference with neck implants like pacemakers if present, and general risks associated with wearing external compression devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking a high dose of acid suppression medication daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have carotid artery disease, uncontrolled thyroid disease, a history of stroke, or Marfan's/Ehlers-Danlos Syndrome.

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I have been diagnosed with glaucoma.

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I use a CPAP or BiPAP machine at night.

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I have had cancer or surgery in my neck area.

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I have a growth in my voice box seen during an examination.

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I use supplemental oxygen.

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I have been diagnosed with achalasia.

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I cannot give consent in English or Spanish.

Select...

I have had surgery on my upper digestive tract before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure response to the UES Compression Device in pepsin positive LPR.

Secondary study objectives

Measure pepsin response to the UES Compression Device in pepsin positive LPR.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.

Group II: ControlPlacebo Group1 Intervention

Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Laryngopharyngeal Reflux (LPR) include proton pump inhibitors (PPIs) and external compression devices like the Reflux Band. PPIs reduce stomach acid production, which helps minimize acid reflux into the larynx and pharynx, alleviating symptoms such as throat irritation and chronic cough. The Reflux Band works by applying external pressure to the upper esophageal sphincter (UES), enhancing its barrier function to prevent acid reflux. This mechanical approach is particularly beneficial for LPR patients who do not respond adequately to acid-suppressing medications alone.

Proton pump inhibitors for the treatment of laryngopharyngeal reflux disease: A protocol for systematic review and meta-analysis.