Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSonic Device | Experimental | SinuSonic Device used twice a day for four to six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSonic Device | Device | A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks | Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15. | Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Nasal Inspiratory Flow Test (PNIF Test) | Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose. | Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks |
| Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Descriptive About Occurrence of Adverse Events | Safety will be evaluated by the Adverse events occurence | 4 to 6 Weeks |
| Evaluation of Results of General Physical Examination | Collection of safety data throughout the whole study period |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zachary M Soler | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinus Center - Medical Univesity of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32104962 | Derived | Soler ZM, Nguyen SA, Salvador C, Lackland T, Desiato VM, Storck K, Schlosser RJ. A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion. Int Forum Allergy Rhinol. 2020 May;10(5):610-618. doi: 10.1002/alr.22537. Epub 2020 Feb 27. |
Not provided
Not provided
Not Applicable. We plan to publish this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SinuSonic Device | SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SinuSonic Device | SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | > 18 years old |
| 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 | Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks | Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15. | Posted | Mean | Standard Deviation | score on a scale | Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks |
|
9 months
This is a minimal risk study based on a commercially available device.
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 | SinuSonic Device | SinuSonic Device used twice a day for four to six weeks. SinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zachary M. Soler | MUSC | (843) 792-3531 | solerz@musc.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 | Jan 12, 2019 | Dec 7, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2019 | Jan 14, 2020 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst. |
| Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks |
| Change in Visual Analog Scale (VAS) | The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):
| Visual Analog Scale (VAS) score at 4 to 6 Weeks |
| Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) | Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst. | Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks |
| 4 to 6 Weeks |
| 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 |
|
| visual analogue scale (VAS) | The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm): Mild = VAS 0-3 Moderate = VAS > 3-7 Severe = VAS > 7-10 | Mean | Standard Deviation | units on a scale |
|
| Total Nasal Symptom Score (TNSS) | Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15. | Mean | Standard Deviation | units on a scale |
|
| Nasal Obstruction and Septoplasty Effectiveness (NOSE) score | Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst. | Mean | Standard Deviation | units on a scale |
|
| 22-item Sino-Nasal Outcome Test (SNOT-22) | Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst. | Mean | Standard Deviation | units on a scale |
|
| peak nasal inspiratory flow (PNIF) | Median | Standard Deviation | L/min |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Peak Nasal Inspiratory Flow Test (PNIF Test) | Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose. | Posted | Median | Standard Deviation | L/min | Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks |
|
|
|
| Secondary | Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score | Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst. | Posted | Mean | Standard Deviation | score on a scale | Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks |
|
|
|
| Secondary | Change in Visual Analog Scale (VAS) | The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):
| Posted | Mean | Standard Deviation | score on a scale | Visual Analog Scale (VAS) score at 4 to 6 Weeks |
|
|
|
| Secondary | Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) | Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst. | Posted | Mean | Standard Deviation | score on a scale | Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks |
|
|
|
| Other Pre-specified | Safety Descriptive About Occurrence of Adverse Events | Safety will be evaluated by the Adverse events occurence | Posted | Number | reported adverse events | 4 to 6 Weeks |
|
|
|
| Other Pre-specified | Evaluation of Results of General Physical Examination | Collection of safety data throughout the whole study period | Not Posted | 4 to 6 Weeks | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
Not provided
Not provided
Not provided
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |