Reflux Band in Laryngopharyngeal Reflux

Laryngopharyngeal Reflux Clinical Trial

Official title:

Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827355
• Other study ID #: 201945
• Secondary ID: K23DK125266
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: April 2026

Study information

• Verified date: September 2023
• Source: University of California, San Diego
• Contact: Esophageal Research Coordinator
• Phone: 8582465236
• Email: mgreytak[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.

Description:

This study seeks to understand if the Reflux Band is an effective treatment for laryngopharyngeal reflux (LPR) in comparison to a sham device. LPR is a syndrome in which acid that is made in the stomach travels up the esophagus and into the throat, causing chronic symptoms including throat clearing, voice hoarseness, sore throat, etc. Participation in the study may or may not benefit you directly, and may result in new knowledge that may help others.

Participation in this study involves: 3 - 4 in person visits (2 of which are part of standard of care) ranging from 30 - 45 minutes each and 2 virtual visits, either by phone or video, each 15 minutes. Participants are assigned with a 50/50 chance (similar to a coin flip) via a computer generator to receive the Reflux Band or sham device (a device that will not provide you medical therapy) which they will wear around their neck nightly while sleeping (6+ hours) over a duration of 8 weeks. The Reflux Band, which has been cleared for use by the FDA, applies pressure to the outside of the neck at the cricoid cartilage, at the middle of the neck, and increases the internal pressure of the muscle separating the throat from the esophagus (upper esophageal sphincter). Participants will only wear the band while sleeping at night and remove in the morning upon waking. The in person visits will occur at one of these UCSD La Jolla locations: the Perlman Medical Office Gastroenterology clinic, the Center for Voice and Swallowing, Altman Clinical and Translational Research Institute (ACTRI) Clinic.

There is an optional 4 week extension at the end of this study in which the Reflux Band will be refit (if sham) to provide the manufacturer's specified pressure. This portion contains 1 virtual follow up during week 10 and an in person follow up during week 12, at which time study participation will conclude.

The most commonly expected risks of the study are skin reaction, discomfort, and difficulty sleeping. These were generally mild and short in duration. No serious risks were observed when the Reflux Band was worn around the neck in previous studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults between 18-99, English or Spanish speaking

• =8 weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)

• Current use of double daily dose acid suppression therapy (ex. omeprazole 40mg, omeprazole 20mg and famotidine 20mg)

• Laryngoscopic exam prior to screening with current symptoms

• At least 1 of the following:

• Elevated reflux testing

• Findings on upper endoscopy that are consistent with pathologic GERD

• Fasting pepsin analysis result of =25 ng/mL within 4 months of enrollment (12 months if treatment plan has not changed) *testing allowed at enrollment if not previously obtained

Exclusion Criteria:

• Prior use of Reflux Band (UES Compression Device)

• Sino-pulmonary conditions (such as asthma, COPD, post-nasal drip, heavy voice use) as primary etiology of laryngeal symptoms as deemed by treating gastroenterologist and / or laryngologist

• Laryngeal mass or lesion on laryngoscopy

• Pregnant or breastfeeding

• Unable to consent in English or Spanish

• Imprisoned

• Patients with a prior foregut surgery

• Patients with a known achalasia diagnosis

• Inability to fast for 4 hours

• Active tobacco use

• Supplemental oxygen use

• Contraindication to UES Compression Device manufacturer guidelines:

• Patients with implants or implant parts that reside in the area where Reflux Band is applied: implanted pacemarker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator (VNS), or other such 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, uncontrolled thyroid disease, a history of cerebrovascular disease, or connective tissue disorder of Marfan's Syndrome or Ehlers-Danlos Syndrome

• Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

Device:
• External Upper Esophageal Sphincter (UES) Compression Device
External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
• Sham Device
External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Cohen SM, Pitman MJ, Noordzij JP, Courey M. Management of dysphonic patients by otolaryngologists. Otolaryngol Head Neck Surg. 2012 Aug;147(2):289-94. doi: 10.1177/0194599812440780. Epub 2012 Feb 24. — View Citation

de Bortoli N, Nacci A, Savarino E, Martinucci I, Bellini M, Fattori B, Ceccarelli L, Costa F, Mumolo MG, Ricchiuti A, Savarino V, Berrettini S, Marchi S. How many cases of laryngopharyngeal reflux suspected by laryngoscopy are gastroesophageal reflux disease-related? World J Gastroenterol. 2012 Aug 28;18(32):4363-70. doi: 10.3748/wjg.v18.i32.4363. — View Citation

Litvinov AV. [Method of tracheobronchial spraying of drugs in aerosols]. Vestn Khir Im I I Grek. 1976 Jan;116(1):100-1. No abstract available. Russian. — View Citation

Olson NR. Laryngopharyngeal manifestations of gastroesophageal reflux disease. Otolaryngol Clin North Am. 1991 Oct;24(5):1201-13. — View Citation

Ruiz R, Jeswani S, Andrews K, Rafii B, Paul BC, Branski RC, Amin MR. Hoarseness and laryngopharyngeal reflux: a survey of primary care physician practice patterns. JAMA Otolaryngol Head Neck Surg. 2014 Mar;140(3):192-6. doi: 10.1001/jamaoto.2013.6533. — View Citation

Shaker R, Babaei A, Naini SR. Prevention of esophagopharyngeal reflux by augmenting the upper esophageal sphincter pressure barrier. Laryngoscope. 2014 Oct;124(10):2268-74. doi: 10.1002/lary.24735. Epub 2014 Jun 27. — View Citation

Slivers SL, Vaezi MF, Vakil MB, et al. Prospective study of upper esophageal sphincter assist device for treating extraesophageal reflux. Otolaryngol Open J. 2016; 2(1): 31-38. doi: 10.17140/OTLOJ-2-109

Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure response to the UES Compression Device in pepsin positive LPR.	Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.	5 years
Secondary	Measure pepsin response to the UES Compression Device in pepsin positive LPR.	Change in salivary pepsin concentration between pre and post treatment.	5 years