Laryngopharyngeal Reflux
Conditions
Brief 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 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.
Interventions
DEVICEUESAD
Device designed to provide modest cricoid pressure to reduce reflux
Sponsors
Somna Therapeutics, L.L.C.
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female persons age 18-90 2. Patients with LPR symptoms (RSI \>13)
Exclusion criteria
1. Pregnant patients per history on initial evaluation. 2. Adults unable to consent in English 3. Patients who are currently imprisoned 4. Patients started on PPI therapy within 4 weeks of study 5. Patients with implants or implant parts that reside in the area where the REZA BAND is applied. 6. Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck. 7. Patients diagnosed with glaucoma. 8. Patients who had a malignancy of the neck, including neck surgery. 9. Patients that may have an altered mental status including due to the use of sedative drugs or narcotics. 10. 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). 11. Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Pepsin Concentration | 2 weeks | Average salivary pepsin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSI Score | 2 weeks | Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity. |
| GerdQ Score | 2 weeks | GERDQ score. Scale of 0-12, higher score indicates increased symptom severity. |
| NGSSIQ Score | 2 weeks | NGSSI questionnaire score |
Participant flow
Recruitment details
Subjects were recruited from the Northwestern Medicine Gastroenterology clinic during the study period beginning 9/1/2015. A total of 15 subjects
Participants by arm
| Arm | Count |
|---|---|
| UESAD Upper Esophageal Sphincter Assist Device
UESAD: Device designed to provide modest cricoid pressure to reduce reflux | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | UESAD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 45.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| GERDQ | 10.4 units on a scale STANDARD_DEVIATION 2.1 |
| NGSSIQ | 43.4 units on a scale STANDARD_DEVIATION 20.1 |
| Pepsin (ng/mL) | 146.5 ng/mL STANDARD_DEVIATION 172.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Reflux Symptom Index (RSI) | 26.0 units on a scale STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Salivary Pepsin Concentration
Average salivary pepsin concentration
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UESAD | Salivary Pepsin Concentration | 158.4 ng/mL | Standard Deviation 150.2 |
p-value: 0.61t-test, 2 sided
Secondary
GerdQ Score
GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UESAD | GerdQ Score | 8.6 units on a scale | Standard Deviation 2.4 |
p-value: <0.01t-test, 2 sided
Secondary
NGSSIQ Score
NGSSI questionnaire score
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UESAD | NGSSIQ Score | 26.8 units on a scale | Standard Deviation 20.8 |
p-value: <0.01t-test, 2 sided
Secondary
RSI Score
Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UESAD | RSI Score | 19.4 units on a scale | Standard Deviation 8.5 |
p-value: <0.01t-test, 2 sided