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Clinical Trial Summary

This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with eustachian tube dysfunction (ETD) or facial pain/pressure. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 3 aims. Aim 1 will examine healthy controls with no signs of upper respiratory infection, inflammation, or ETD to determine if exhaled nasal Nitric Oxide is increased. Nitric Oxide is a compound in the body that acts as a blood vessel relaxant. Acoustic energy (humming) has been shown to increase nasal Nitric Oxide dramatically, thus equalization of gas pressures between the middle ear, the paranasal sinuses and the nasal cavity may very well explain any efficacy noted. Aim 2 will be performed to examine therapeutic efficacy for ETD. Aim 3 will be performed to examine therapeutic efficacy for sinus pain/pressure.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04404036
Study type Interventional
Source Medical University of South Carolina
Contact Matthew Germroth
Phone 8438761166
Email germroth@musc.edu
Status Recruiting
Phase N/A
Start date August 11, 2020
Completion date July 1, 2025

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