Summary

Eligibility
for people ages 18-89 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Rena Yadlapati, M.D. (ucsd)
Photo of Rena Yadlapati
Rena Yadlapati

Description

Summary

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

Details

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.

Keywords

Gastroesophageal Reflux Laryngopharyngeal Reflux esophageal disorders Esophagitis, Peptic Reflux Band® Upper Esophageal Sphincter (UES) Assist Device Symptomatic

Eligibility

You can join if…

Open to people ages 18-89

  • 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

You CAN'T join if...

  • 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.

Location

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UC Health

  • Rena Yadlapati, M.D. (ucsd)
    Dr. Yadlapati is medical director of the Center for Esophageal Diseases at UC San Diego Health and treats gastroesophageal reflux disease (GERD) and related conditions such as voice complaints (laryngopharyngeal reflux) and Barrett’s esophagus, swallowing disorders such as achalasia and esophageal motility disorders, and eosinophilic esophagitis.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03619811
Study Type
Interventional
Last Updated