Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

N/ACompletedNCT03619811

University of California, San Diego43 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Laryngopharyngeal Reflux

Interventions

Reflux Band® Upper Esophageal Sphincter (UES) Assist DeviceDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of California, San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 8 (Completion)

Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score

Time frame: Week 4

Data from ClinicalTrials.gov

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