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OpenTrials
Completed

NCT Number: NCT03619811

Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

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

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflux Band® Upper Esophageal Sphincter (UES) Assist Device

Diagnostic 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.

Primary outcomes

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

    Time frame: Week 8 (Completion)

    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.

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

    Time frame: Week 4

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2018
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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