Clinical trial NCT03619811: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Official title: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Laryngopharyngeal Reflux
Keywords: esophageal disorders
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
timeFrame: Week 8 (Completion)
measure: Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Rena Yadlapati, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yadlapati R, Pandolfino JE, Greytak M, Cahoon J, Clarke M, Clary M, Fink D, Menard-Katcher P, Vahabzadeh-Hagh AM, Weissbrod P, Gupta S, Kaizer A, Wani S. Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Dig Dis Sci. 2022 Jul;67(7):3045-3054. doi: 10.1007/s10620-021-07172-2. Epub 2021 Jul 18.