Gastroesophageal Reflux, Laryngopharyngeal Reflux
Conditions
Keywords
esophageal disorders
Brief summary
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
Detailed description
Reflux associated laryngeal symptoms, coined laryngopharyngeal reflux, occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.
Interventions
DIAGNOSTIC_TESTReflux Band® Upper Esophageal Sphincter (UES) Assist Device
UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-89 years male and female, * \>8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness, * naïve to PPI or able to stop for 8 weeks
Exclusion criteria
* Laryngeal mass lesion on laryngoscopy; * Pregnant; * Unable to consent in English; * Imprisoned; * PPI intolerance; * Contraindication to UESAD use per manufacturer guidelines which include: * Patients with implants or implant parts that reside in the area where UESAD is applied. * Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar 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, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | Week 8 (Completion) | Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symptomatic This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device: UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Symptomatic |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 50.48 years STANDARD_DEVIATION 15.1 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized White / Caucasian | 26 Participants |
| Reflux Symptom Index Baseline | 24.1 units on a scale STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 1 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Time frame: Week 8 (Completion)
Population: This analysis includes the participants that completed phase 1 \& 2 of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 15.5 score on a scale | Standard Deviation 10.3 |
Primary
Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score
Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.
Time frame: Week 4
Population: This population completed phase 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 21.9 score on a scale | Standard Deviation 9.7 |