Laryngopharyngeal Reflux
Conditions
Brief summary
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
Detailed description
The purpose of the study is to determine the safety and effectiveness of non-invasive Reza Band UES Assist Device for the treatment of esophagopharyngeal reflux with extra-esophageal symptoms (chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing). Reza Band is to be worn when sleeping. The patient will put the Reza Band on at bedtime and take it off upon waking. This is a prospective, non-randomized, open label, multicenter study designed to assess the safety and effectiveness of the Reza Band. At up to 5 investigational sites, up to 100 subjects will be enrolled. The primary effectiveness endpoint is to be evaluated by the Reflux Symptom Index (RSI). Success is defined as \>25% reduction in the RSI at the last follow-up, as compared to the baseline RSI. The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45. All adverse reactions being reported will be evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band. Since some subjects may report the same event several times (e.g., redness), the first occurrence of the worst reported case of the event will be used for the purpose of analysis. The incidence of site reactions, including laryngospasm, choking, pain, cough and hoarseness will be summarized. Exact 95% confidence intervals for the incidence rate of site reactions will be presented.
Interventions
DEVICEReza Band UES Assist Device
Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
Sponsors
Somna Therapeutics, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 year of age or older * The patient must be willing and able to provide informed consent. * Understands the clinical study requirements and is able to comply with follow-up schedule. * Clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing) * Reflux Symptom Index (RSI) \>13
Exclusion criteria
* Currently being treated with another investigational medical device and/or drug * Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP) * The patient is female and is of child bearing potential and is not using an acceptable method of birth control, or is pregnant or breast feeding. * Previous head or neck surgery or radiation * Carotid artery disease, thyroid disease, or history of cerebral vascular disease * Suspected esophageal cancer * Has either a pacemaker or implanted cardioverter defibrillator (ICD) * Nasopharyngeal cancer * Previously undergone Nissen Fundoplication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks | 4 Weeks minus Baseline | The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45). |
| Primary Safety | 4 Week Follow-up | Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score | 4 Weeks minus Baseline | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | 4 Weeks minus Baseline | The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 4 Weeks | Patients provide their perception of the device at the end of the study. |
| Investigator Questionnaire | 4 Weeks | Investigators provide their perception of the device at the end of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fitted With Reza Band UES Assist Device Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits. | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | Fitted With Reza Band UES Assist Device |
|---|---|
| Age, Continuous | 48.8 Years STANDARD_DEVIATION 13.7 |
| BMI | 25.5 kg/m^2 STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized African American | 4 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 77 participants |
| Race/Ethnicity, Customized Hispanic | 8 participants |
| Race/Ethnicity, Customized Not Reported | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 29 Participants |
| Weight | 160.0 pounds STANDARD_DEVIATION 31.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks
The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).
Time frame: 4 Weeks minus Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reza Band | Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks | -54.3 Per Cent Change | Standard Deviation 27.1 |
Comparison: The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.p-value: <0.05t-test, 1 sided
Primary
Primary Safety
Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.
Time frame: 4 Week Follow-up
Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reza Band | Primary Safety | 58.6 % Reporting Any Adverse Event |
Secondary
Functional Outcomes of Sleep Questionnaire (FOSQ)
The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.
Time frame: 4 Weeks minus Baseline
Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reza Band | Functional Outcomes of Sleep Questionnaire (FOSQ) | 0.80 Change in Units on a Scale | Standard Deviation 11.04 |
Secondary
SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: 4 Weeks minus Baseline
Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reza Band | SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score | 0.56 Change in Units on a Scale | Standard Deviation 6.88 |
Other Pre-specified
Investigator Questionnaire
Investigators provide their perception of the device at the end of the study.
Time frame: 4 Weeks
Other Pre-specified
Patient Satisfaction
Patients provide their perception of the device at the end of the study.
Time frame: 4 Weeks