Clinical trial NCT02552966: Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin
Official title: Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngopharyngeal Reflux
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Somna Therapeutics, L.L.C.
First posted: 2015-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary Pepsin Concentration
timeFrame: 2 weeks
Secondary outcomes:
measure: RSI Score
timeFrame: 2 weeks
measure: GerdQ Score
timeFrame: 2 weeks
measure: NGSSIQ Score
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: John E Pandolfino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1572-0241.2001.03681.x.
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.
citation: Yadlapati R, Craft J, Adkins CJ, Pandolfino JE. The Upper Esophageal Sphincter Assist Device Is Associated With Symptom Response in Reflux-Associated Laryngeal Symptoms. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1670-1672. doi: 10.1016/j.cgh.2018.01.031. Epub 2018 Jan 31.