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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02552966
Other study ID # STU00201370
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date August 31, 2018

Study information

Verified date July 2019
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2018
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
UESAD
Device designed to provide modest cricoid pressure to reduce reflux

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Somna Therapeutics, L.L.C.

References & Publications (2)

El-Serag HB, Lee P, Buchner A, Inadomi JM, Gavin M, McCarthy DM. Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial. Am J Gastroenterol. 2001 Apr;96(4):979-83. — View Citation

Francis DO, Rymer JA, Slaughter JC, Choksi Y, Jiramongkolchai P, Ogbeide E, Tran C, Goutte M, Garrett CG, Hagaman D, Vaezi MF. High economic burden of caring for patients with suspected extraesophageal reflux. Am J Gastroenterol. 2013 Jun;108(6):905-11. doi: 10.1038/ajg.2013.69. Epub 2013 Apr 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Salivary Pepsin Concentration Average salivary pepsin concentration 2 weeks
Secondary RSI Score Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity. 2 weeks
Secondary GerdQ Score GERDQ score. Scale of 0-12, higher score indicates increased symptom severity. 2 weeks
Secondary NGSSIQ Score NGSSI questionnaire score 2 weeks
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