Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Somna Therapeutics, L.L.C. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UESAD | Experimental | Upper Esophageal Sphincter Assist Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UESAD | Device | Device designed to provide modest cricoid pressure to reduce reflux |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Pepsin Concentration | Average salivary pepsin concentration | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RSI Score | Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity. | 2 weeks |
| GerdQ Score | GERDQ score. Scale of 0-12, higher score indicates increased symptom severity. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John E Pandolfino, MD | Northwestern University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11316215 | Background | 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. | |
| 23545710 | Background | Francis 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. |
Not provided
Not provided
Not provided
Subjects were recruited from the Northwestern Medicine Gastroenterology clinic during the study period beginning 9/1/2015. A total of 15 subjects
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | UESAD | Upper Esophageal Sphincter Assist Device UESAD: Device designed to provide modest cricoid pressure to reduce reflux |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UESAD | Upper Esophageal Sphincter Assist Device UESAD: Device designed to provide modest cricoid pressure to reduce reflux |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Salivary Pepsin Concentration | Average salivary pepsin concentration | Twelve subjects provided post-treatment salivary samples for pepsin analysis. While the subject flow shows 20 subjects (all of which completed baseline pepsin analysis), only 12 completed post-treatment testing. | Posted | Mean | Standard Deviation | ng/mL | 2 weeks |
|
|
24 days
adverse events were collected throughout the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UESAD | Upper Esophageal Sphincter Assist Device UESAD: Device designed to provide modest cricoid pressure to reduce reflux |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Pandolfino, Principal Investigator | Northwestern University | 3126950182 | j-pandolfino@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2015 | Jun 11, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 weeks |
| NGSSIQ Score | NGSSI questionnaire score | 2 weeks |
| 29408585 | Derived | 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| GERDQ | GastroEsophageal Reflux Disease Questionnaire (GERDQ). This scale measures symptom burden of gastroesophageal reflux disease (GERD). A higher score indicated greater symptom severity on a scale of 0 to 18. No subscales are combined to compute the total score. "Units on a scale" is the appropriate Unit of Measure. | Mean | Standard Deviation | units on a scale |
|
| Reflux Symptom Index (RSI) | Reflux Symptom Index (RSI). This questionnaire measures laryngeal symptom severity for subjects experiencing reflux-related laryngeal symptoms (e.g. sore throat, throat clearing, post nasal drip, globus and cough). A higher score indicates greater severity on a scale of 0 to 45. No subscales are used to compute a total score. "Units on a scale" is the appropriate unit of measure for this questionnaire. | Mean | Standard Deviation | units on a scale |
|
| NGSSIQ | Nocturnal GERD Symptom Severity & Impact Questionnaire (NGSSIQ). This questionnaire assesses nighttime symptom severity and the impact of nighttime GERD symptoms. A higher scoe indicates greater severity on a scale of 0 to 60. No subscales were used to calculate the composite score. "Units on a scale" is the appropriate unit of measure for this questionnaire. | Mean | Standard Deviation | units on a scale |
|
| Pepsin (ng/mL) | Salivary Pepsin (referred to as "pepsin") is a biomarker measured in this study in ng/mL. | Mean | Standard Deviation | ng/mL |
|
|
|
| Secondary | RSI Score | Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity. | 15 subjects completed the RSI post-treatment. The subject flow shows 20 subjects completing this questionnaire at baseline, but this section reflects the 15 subjects who completed this questionnaire post-treatment. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
|
| Secondary | GerdQ Score | GERDQ score. Scale of 0-12, higher score indicates increased symptom severity. | Fifteen subjects completed the post-treatment GERDQ questionnaire. While 20 subjects completed the questionnaire at baseline, this section contains results from the 15 who completed the questionnaire 2 weeks post UESAD treatment. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
|
| Secondary | NGSSIQ Score | NGSSI questionnaire score | Fifteen subjects completed the post-treatment questionnaire. While 20 subjects (as indicated on the participant flow section) completed the baseline questionnaire, this section reflects the results of the 15 subjects who completed the questionnaire at 2 weeks post UESAD treatment. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |