Reflux Band in Laryngopharyngeal Reflux

  • STATUS
    Recruiting
  • End date
    Apr 4, 2026
  • participants needed
    72
  • sponsor
    University of California, San Diego
Updated on 4 November 2021

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.

Details
Condition Gastroesophageal Reflux Disease (GERD), Laryngopharyngeal Reflux, Non-Erosive Reflux Disease (NERD), Gastroesophageal Reflux
Treatment Sham device, External Upper Esophageal Sphincter (UES) Compression Device
Clinical Study IdentifierNCT04827355
SponsorUniversity of California, San Diego
Last Modified on4 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults between 18-99, English or Spanish speaking
weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)
Current use of double dose PPI (equivalent to: omeprazole 40mg daily, lansoprazole 30mg daily, esomeprazole 40mg daily, dexlansoprazole 60mg daily, rabeprazole 20mg daily, or pantoprazole 80mg daily)
Laryngoscopic exam within 12 months prior to screening with reflux finding score >7
Fasting salivary pepsin concentration of 25 ng/mL at screening or within 4 months of enrollment

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
PPI intolerance
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
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