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Reflux Band in Laryngopharyngeal Reflux

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ClinicalTrials.gov Identifier: NCT04827355
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rena Yadlapati, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux Device: External Upper Esophageal Sphincter (UES) Compression Device Device: Sham Device Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to one of two arms: control or experimental. Randomization will be 1:1 to control (sham, known not to provide intervention) and experimental (fit to manufacturer guidelines).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Sham Comparator: Control
Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.
Device: Sham Device
External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.

Experimental: Experimental
Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.
Device: External Upper Esophageal Sphincter (UES) Compression Device
External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.
Other Names:
  • Reflux Band
  • Reza Band




Primary Outcome Measures :
  1. Measure response to the UES Compression Device in pepsin positive LPR. [ Time Frame: 5 years ]
    Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.


Secondary Outcome Measures :
  1. Measure pepsin response to the UES Compression Device in pepsin positive LPR. [ Time Frame: 5 years ]
    Change in salivary pepsin concentration between pre and post treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827355


Contacts
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Contact: Esophageal Research Coordinator 8582465236 mgreytak@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Esophageal Research Coordinator    858-246-5236    mgreytak@ucsd.edu   
Principal Investigator: Rena Yadlapati, MD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Rena Yadlapati, MD, MSHS UC San Diego Health
  Study Documents (Full-Text)

Documents provided by Rena Yadlapati, University of California, San Diego:
Informed Consent Form  [PDF] July 22, 2021

Publications of Results:
Other Publications:
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Responsible Party: Rena Yadlapati, Associate Professor of Clinical Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04827355    
Other Study ID Numbers: 201945
K23DK125266 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rena Yadlapati, University of California, San Diego:
Proton Pump Inhibitor (PPI)
Upper Esophageal Sphincter (UES) Compression Device
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases