Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

Detailed Description
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Reflux associated laryngeal symptoms, coined laryngopharyngeal reflux, occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.

Official Title
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Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux, Laryngopharyngeal Reflux

Intervention / Treatment
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* Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-89 years male and female, >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness, naïve to PPI or able to stop for 8 weeks Exclusion Criteria: Laryngeal mass lesion on laryngoscopy; Pregnant; Unable to consent in English; Imprisoned; PPI intolerance; Contraindication to UESAD use per manufacturer guidelines which include: Patients with implants or implant parts that reside in the area where UESAD is applied. Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck. Patients diagnosed with glaucoma. Patients who had a malignancy of the neck, including neck surgery. Patients that may have an altered mental status including due to the use of sedative drugs or narcotics. Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome). Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic<br>This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device) | Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device<br>* UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms. | Week 8 (Completion) | 
| Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal disorders