Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Gastroesophageal Reflux Clinical Trial

Official title:

Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619811
• Other study ID #: 18-0205
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

Diagnostic Test:
• Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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