Laryngopharyngeal RefluxNCT02552966
Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin
A study testing UESAD in people with Laryngopharyngeal Reflux, run by Northwestern University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- What is being tested?
- UESAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female persons age 18-90
- Patients with LPR symptoms (RSI >13)
Who cannot join
- Pregnant patients per history on initial evaluation.
- Adults unable to consent in English
- Patients who are currently imprisoned
- Patients started on PPI therapy within 4 weeks of study
- Patients with implants or implant parts that reside in the area where the REZA BAND is applied.
- Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
Show all 11Show fewer
- 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, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
- Patients who use nocturnal NIV machines such as CPAP or BiPAP.
About this study
Official title: Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study
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.
Read the detailed description
A cost-effective and care appropriate algorithm to streamline the diagnosis and management of patients with laryngopharyngeal reflux (LPR) has not been described. 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. A study examining salivary pepsin levels for patients pre- and post-fundoplication for LPR found that all patients with positive preoperative pepsin levels and postoperative elimination had symptom improvement, suggesting that changes in pepsin level may be reflective of surgical responsiveness. This study seeks to explore the therapeutic role of the UESAD in patients with LPR symptoms, and measure its effectiveness by objective criteria (salivary pepsin) and symptomatic improvement. In this study, 25 patients seen in GI clinic with laryngeal complaints will complete validated symptom questionnaires - the RSI, GerdQ and N-GSSIQ scores. Those with an RSI > 13 and GerdQ > 8 will be included. They will submit 3 baseline sputum samples for pepsin analysis, taken upon awaking. They will then be advised to use the UESAD nightly for 2 weeks. 3 follow-up sputum samples for pepsin analysis will be taken and symptom scores reevaluated after the 2 week period.
- Conditions
- Laryngopharyngeal Reflux
- Being tested
- UESAD
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UESADDevice
Device designed to provide modest cricoid pressure to reduce reflux
| Study group | Role | What they receive |
|---|---|---|
| UESAD | Experimental | Upper Esophageal Sphincter Assist Device Receives: Device: UESAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Pepsin Concentration
Average salivary pepsin concentration
Measured: 2 weeks
Secondary outcomes (3)
RSI Score
Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.
Measured: 2 weeks
GerdQ Score
GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.
Measured: 2 weeks
NGSSIQ Score
NGSSI questionnaire score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Somna Therapeutics, L.L.C.
- Responsible party
- Principal investigator, John Pandolfino, Northwestern University
- Investigators
- John E Pandolfino, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552966
- Sponsor's protocol ID
- STU00201370
- Status last verified
- Jul 2019
- First submitted
- 16 Sep 2015
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. doi: 10.1111/j.1572-0241.2001.03681.x.
PubMed 11316215Francis 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.
PubMed 23545710Yadlapati 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.
PubMed 29408585
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impacts of an Upper Esophageal Sphincter Assist Device on Laryngeal Symptoms and Salivary Pepsin: A Pilot Study
- ClinicalTrials.gov ID
- NCT02552966
- Acronym / sponsor ID
- STU00201370
- Conditions
- Laryngopharyngeal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Somna Therapeutics, L.L.C.
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A cost-effective and care appropriate algorithm to streamline the diagnosis and management of patients with laryngopharyngeal reflux (LPR) has not been described. 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. A study examining salivary pepsin levels for patients pre- and post-fundoplication for LPR found that all patients with positive preoperative pepsin levels and postoperative elimination had symptom improvement, suggesting that changes in pepsin level may be reflective of surgical responsiveness. This study seeks to explore the therapeutic role of the UESAD in patients with LPR symptoms, and measure its effectiveness by objective criteria (salivary pepsin) and symptomatic improvement. In this study, 25 patients seen in GI clinic with laryngeal complaints will complete validated symptom questionnaires - the RSI, GerdQ and N-GSSIQ scores. Those with an RSI > 13 and GerdQ > 8 will be included. They will submit 3 baseline sputum samples for pepsin analysis, taken upon awaking. They will then be advised to use the UESAD nightly for 2 weeks. 3 follow-up sputum samples for pepsin analysis will be taken and symptom scores reevaluated after the 2 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UESAD | Experimental | Device: UESADUpper Esophageal Sphincter Assist Device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female persons age 18-90
- Patients with LPR symptoms (RSI >13)
Key exclusion criteria (11 listed)
- Pregnant patients per history on initial evaluation.
- Adults unable to consent in English
- Patients who are currently imprisoned
- Patients started on PPI therapy within 4 weeks of study
- Patients with implants or implant parts that reside in the area where the REZA BAND is applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UESADDevice designed to provide modest cricoid pressure to reduce reflux | Device | UESAD |
Primary outcome
Salivary Pepsin Concentration
Time frame: 2 weeks
Average salivary pepsin concentration
3 secondary outcomes
RSI Score
Time frame: 2 weeks
GerdQ Score
Time frame: 2 weeks
NGSSIQ Score
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11316215El-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. doi: 10.1111/j.1572-0241.2001.03681.x.
- Background: PubMed 23545710Francis 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.
- Derived from this study: PubMed 29408585Yadlapati 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.
Related trials for Laryngopharyngeal Reflux
RecruitingPhase 2
Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction
Laryngopharyngeal Reflux
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Recruiting
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
GERD (Gastroesophageal Reflux Disease), NERD
Not yet recruitingPhase 4
Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease
Laryngopharyngeal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Pandolfino, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing UESAD in people with Laryngopharyngeal Reflux, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Pepsin Concentration (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552966, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.