The Safety and Efficacy of a SinuSonic Intervention
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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