The Safety and Efficacy of a SinuSonic Intervention

Completed · Not applicable

Conditions studied: Nasal Congestion

In brief

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.

Key facts

Study ID: NCT03906968
Run by: Medical University of South Carolina
People needed: 40
Starts: 2019-03-31
Expected to finish: 2019-12-16
Last updated by the study team: 2021-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Sinus Center - Medical Univesity of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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