Laryngopharyngeal Reflux Clinical Trial
Official title:
Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study
Verified date | July 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Northwestern University | Somna Therapeutics, L.L.C. |
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
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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