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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States
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
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
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
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
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Time frame: 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.
Time frame: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks