Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin

February 24, 2020 updated by: John Pandolfino, Northwestern University

Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study

It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist Device (UESAD) is a novel device that applies relatively modest external cricoid pressure, which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients with reflux associated laryngeal symptoms and implicated in the pathogenesis of laryngopharyngeal reflux. This study will assess the effectiveness of a UESAD worn for 2 weeks on LPR symptoms and salivary pepsin levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A cost-effective and care appropriate algorithm to streamline the diagnosis and management of patients with laryngopharyngeal reflux (LPR) has not been described. It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist Device (UESAD) is a novel device that applies relatively modest external cricoid pressure, which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients with reflux associated laryngeal symptoms and implicated in the pathogenesis of laryngopharyngeal reflux. A study examining salivary pepsin levels for patients pre- and post-fundoplication for LPR found that all patients with positive preoperative pepsin levels and postoperative elimination had symptom improvement, suggesting that changes in pepsin level may be reflective of surgical responsiveness. This study seeks to explore the therapeutic role of the UESAD in patients with LPR symptoms, and measure its effectiveness by objective criteria (salivary pepsin) and symptomatic improvement. In this study, 25 patients seen in GI clinic with laryngeal complaints will complete validated symptom questionnaires - the RSI, GerdQ and N-GSSIQ scores. Those with an RSI > 13 and GerdQ > 8 will be included. They will submit 3 baseline sputum samples for pepsin analysis, taken upon awaking. They will then be advised to use the UESAD nightly for 2 weeks. 3 follow-up sputum samples for pepsin analysis will be taken and symptom scores reevaluated after the 2 week period.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female persons age 18-90
  2. Patients with LPR symptoms (RSI >13)

Exclusion Criteria:

  1. Pregnant patients per history on initial evaluation.
  2. Adults unable to consent in English
  3. Patients who are currently imprisoned
  4. Patients started on PPI therapy within 4 weeks of study
  5. Patients with implants or implant parts that reside in the area where the REZA BAND is applied.
  6. Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
  7. Patients diagnosed with glaucoma.
  8. Patients who had a malignancy of the neck, including neck surgery.
  9. Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
  10. 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).
  11. Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UESAD
Upper Esophageal Sphincter Assist Device
Device: UESAD
Device designed to provide modest cricoid pressure to reduce reflux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Pepsin Concentration
Time Frame: 2 weeks
Average salivary pepsin concentration
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RSI Score
Time Frame: 2 weeks
Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.
2 weeks
GerdQ Score
Time Frame: 2 weeks
GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.
2 weeks
NGSSIQ Score
Time Frame: 2 weeks
NGSSI questionnaire score
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Somna Therapeutics, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201370

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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