SinuSonic Study for Adults With Nasal Congestion
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Nasal Congestion
- Sponsor
- Medical University of South Carolina
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults ≥18 years of age
- •Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of \>5 (10 point VAS scale)
Exclusion Criteria
- •Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)
- •Inability to read and understand English
- •Allergic sensitivity to silicone or any other component of device
- •History of severe nose bleeding within last 3 months
- •Anticoagulation (Aspirin is acceptable)
- •Known pregnancy
- •Current nasal crusting or ulceration revealed on rhinoscopy
- •Inability to perform treatment due to underlying medical condition
- •Topical decongestant use in last week
Outcomes
Primary Outcomes
Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks
Time Frame: 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 Outcomes
- Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score(Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks)
- Change in Visual Analog Scale (VAS)(Visual Analog Scale (VAS) score at 4 to 6 Weeks)
- Change in Peak Nasal Inspiratory Flow Test (PNIF Test)(Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks)
- Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)(Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks)