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Reflux Band in Laryngopharyngeal Reflux

Primary Purpose

Laryngopharyngeal Reflux

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

External Upper Esophageal Sphincter (UES) Compression Device

Sham Device

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux focused on measuring Proton Pump Inhibitor (PPI), Upper Esophageal Sphincter (UES) Compression Device

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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
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.

Sites / Locations

University of California, San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.

Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measure pepsin response to the UES Compression Device in pepsin positive LPR.

Change in salivary pepsin concentration between pre and post treatment.

Full Information

NCT ID

NCT04827355

First Posted

March 29, 2021

Last Updated

September 7, 2023

Sponsor

University of California, San Diego

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04827355

Brief Title

Reflux Band in Laryngopharyngeal Reflux

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 7, 2021 (Actual)

Primary Completion Date

April 2026 (Anticipated)

Study Completion Date

April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laryngopharyngeal Reflux

Keywords

Proton Pump Inhibitor (PPI), Upper Esophageal Sphincter (UES) Compression Device

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.

Intervention Type

Device

Intervention Name(s)

External Upper Esophageal Sphincter (UES) Compression Device

Other Intervention Name(s)

Reflux Band, Reza Band

Intervention Description

External Upper Esophageal Sphincter (UES) Compression Device fit to manufacturer guidelines.

Intervention Type

Device

Intervention Name(s)

Sham Device

Intervention Description

External Upper Esophageal Sphincter (UES) Compression Device fit to pressure known not to provide treatment.

Primary Outcome Measure Information:

Title

Measure response to the UES Compression Device in pepsin positive LPR.

Description

Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Measure pepsin response to the UES Compression Device in pepsin positive LPR.

Description

Change in salivary pepsin concentration between pre and post treatment.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Esophageal Research Coordinator

Phone

8582465236

mgreytak@ucsd.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rena Yadlapati, MD, MSHS

Organizational Affiliation

UC San Diego Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Esophageal Research Coordinator

Phone

858-246-5236

mgreytak@ucsd.edu

First Name & Middle Initial & Last Name & Degree

Rena Yadlapati, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared with other researchers.

Citations:

PubMed Identifier

16928254

Citation

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.

Results Reference

background

PubMed Identifier

1754220

Citation

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

Results Reference

background

PubMed Identifier

22368039

Citation

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.

Results Reference

background

PubMed Identifier

24481258

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.

Results Reference

background

PubMed Identifier

1020172

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.

Results Reference

background

PubMed Identifier

22969200

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.

Results Reference

background

PubMed Identifier

24782387

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.

Results Reference

result

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

Results Reference

result

PubMed Identifier

29408585

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.

Results Reference

result

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Reflux Band in Laryngopharyngeal Reflux

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