N/A
Completed N=20
Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin
Laryngopharyngeal Reflux
Source: ClinicalTrials.gov NCT02552966 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Salivary Pepsin Concentration — 158.4 ng/mL — p=0.61
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary Pepsin Concentration |
158.4 | 0.61 |
| SECONDARY RSI Score |
19.4 | <0.01 sig |
| SECONDARY GerdQ Score |
8.6 | <0.01 sig |
| SECONDARY NGSSIQ Score |
26.8 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female persons age 18-90
- Patients with LPR symptoms (RSI >13)
Exclusion Criteria
- Pregnant patients per history on initial evaluation.
- Adults unable to consent in English
- Patients who are currently imprisoned
- Patients started on PPI therapy within 4 weeks of study
- Patients with implants or implant parts that reside in the area where the REZA BAND 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.
Data sourced from ClinicalTrials.gov (NCT02552966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.