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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reza Band UES Assist Device | Active Comparator | Patient is own control. Compare baseline to last follow-up after using device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reza Band UES Assist Device | Device | Device is worn by patient to reduce or eliminate laryngopharyngeal reflux |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 Weeks minus Baseline |
| 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. | 4 Week Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patients provide their perception of the device at the end of the study. | 4 Weeks |
| Investigator Questionnaire | Investigators provide their perception of the device at the end of the study. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Alan Raymond | New York | New York | 10016 | United States | ||
| Madison ENT & Facial Plastic surgery |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fitted With Reza Band UES Assist Device | Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who enrolled in the study and had a Reza Band fitted by the Investigator and who had at least one post-baseline RSI assessment were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | Posted | Mean | Standard Deviation | Per Cent Change | 4 Weeks minus Baseline |
|
|
Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fitted With Reza Band UES Assist Device | Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reza Band Comfort | Social circumstances | Non-systematic Assessment | Woke up because Reza Band was too uncomfortable |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Miller | Somna Therapeutics, L.L.C. | 262-345-5553 | 102 | jmiller@somnatherapeutics.com |
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| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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| 4 Weeks minus Baseline |
| 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. | 4 Weeks minus Baseline |
| 4 Weeks |
| New York |
| New York |
| 10016 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Aurora Health Care | Summit | Wisconsin | 50366 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | pounds |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| 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. | 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). | Posted | Number | % Reporting Any Adverse Event | 4 Week Follow-up |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | Change in Units on a Scale | 4 Weeks minus Baseline |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | Change in Units on a Scale | 4 Weeks minus Baseline |
|
|
|
| Other Pre-specified | Patient Satisfaction | Patients provide their perception of the device at the end of the study. | Not Posted | 4 Weeks |
| Other Pre-specified | Investigator Questionnaire | Investigators provide their perception of the device at the end of the study. | Not Posted | 4 Weeks |
| 0 |
| 95 |
| 7 |
| 95 |
|
| Post Nasal Drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient reported post nasal drip while wearing Reza Band |
|
| Temporomandibular Joint Disorders | General disorders | Non-systematic Assessment | TMJ was noted following a dental procedure. Determined by the investigator to not be related to the device. |
|
| Bruised neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient reported sleeping on stomach which resulted in bruising of the neck from the device. |
|
| Biopsies due to Colonoscopy | Gastrointestinal disorders | Non-systematic Assessment | Two biopsies taken as a result of colonoscopy. Determined by the investigator not to be related to the device. |
|
| Fell Down | General disorders | Non-systematic Assessment | Fell down in garage and injured foot. Determined by the investigator not to be related to the device. |
|
| Throat infection | Ear and labyrinth disorders | Non-systematic Assessment | Infection that was ongoing and treated by the investigator with antibiotics. Determined by the investigator not to be related to the device. |
|
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| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |