Nasal Congestion
Conditions
Brief summary
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.
Interventions
DEVICESinuSonic Device
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥18 years of age 2. Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of \>5 (10 point VAS scale)
Exclusion criteria
1. Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp) 2. Inability to read and understand English 3. Allergic sensitivity to silicone or any other component of device 4. History of severe nose bleeding within last 3 months 5. Anticoagulation (Aspirin is acceptable) 6. Known pregnancy 7. Current nasal crusting or ulceration revealed on rhinoscopy 8. Inability to perform treatment due to underlying medical condition 9. Topical decongestant use in last week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Nasal Inspiratory Flow Test (PNIF Test) | Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks | 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. |
| Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score | Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks | 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. |
| Change in Visual Analog Scale (VAS) | Visual Analog Scale (VAS) score at 4 to 6 Weeks | 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 |
| Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) | Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Descriptive About Occurrence of Adverse Events | 4 to 6 Weeks | Safety will be evaluated by the Adverse events occurence |
| Evaluation of Results of General Physical Examination | 4 to 6 Weeks | Collection of safety data throughout the whole study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | SinuSonic Device |
|---|---|
| 22-item Sino-Nasal Outcome Test (SNOT-22) | 31.7 units on a scale STANDARD_DEVIATION 20.3 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 39.1 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nasal Obstruction and Septoplasty Effectiveness (NOSE) score | 50.4 units on a scale STANDARD_DEVIATION 19.9 |
| peak nasal inspiratory flow (PNIF) | 79.5 L/min STANDARD_DEVIATION 43.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 3 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 26 Participants |
| Total Nasal Symptom Score (TNSS) | 7.2 units on a scale STANDARD_DEVIATION 3.5 |
| visual analogue scale (VAS) | 5.8 units on a scale STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks | 3.5 score on a scale | Standard Deviation 3.1 |
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.
Time frame: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) | 23.3 score on a scale | Standard Deviation 17.2 |
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.
Time frame: Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Change in Peak Nasal Inspiratory Flow Test (PNIF Test) | 104.5 L/min | Standard Deviation 41.3 |
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.
Time frame: Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score | 14.2 score on a scale | Standard Deviation 12.7 |
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): * Mild = VAS 0-3 * Moderate = VAS \> 3-7 * Severe = VAS \> 7-10
Time frame: Visual Analog Scale (VAS) score at 4 to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SinuSonic Device | Change in Visual Analog Scale (VAS) | 2.6 score on a scale | Standard Deviation 2.3 |
Other Pre-specified
Evaluation of Results of General Physical Examination
Collection of safety data throughout the whole study period
Time frame: 4 to 6 Weeks
Other Pre-specified
Safety Descriptive About Occurrence of Adverse Events
Safety will be evaluated by the Adverse events occurence
Time frame: 4 to 6 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SinuSonic Device | Safety Descriptive About Occurrence of Adverse Events | 0 reported adverse events |