NCT02552966

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

Completed NA Results posted Last updated 26 February 2020

What this trial tests

NA trial testing UESAD in Laryngopharyngeal Reflux in 20 participants. Completed in 31 August 2018.

Timeline

1 September 2015

Primary endpoint
31 August 2017

31 August 2018

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 September 2015
Primary completion	31 August 2017
Estimated completion	31 August 2018

Drugs / interventions tested

• UESAD

Conditions studied

• Laryngopharyngeal Reflux — all drugs for Laryngopharyngeal Reflux →

Sponsor

Northwestern University

Who can join

Adults 18 to 90, any sex, with Laryngopharyngeal Reflux. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Salivary Pepsin Concentration Primary · 2 weeks

Average salivary pepsin concentration

Group	Value	95% CI
UESAD	158.4	± 150.2

RSI Score Secondary · 2 weeks

Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.

Group	Value	95% CI
UESAD	19.4	± 8.5

GerdQ Score Secondary · 2 weeks

GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.

Group	Value	95% CI
UESAD	8.6	± 2.4

NGSSIQ Score Secondary · 2 weeks

NGSSI questionnaire score

Group	Value	95% CI
UESAD	26.8	± 20.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.