NCT03906968

The Safety and Efficacy of a SinuSonic Intervention

SinuSonic Study for Adults With Nasal Congestion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Congestion

Interventions

Type	Name	Description
DEVICE	SinuSonic Device	A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion

Timeline

• Start date: 2019-03-31
• Primary completion: 2019-12-15
• Completion: 2019-12-16
• First posted: 2019-04-08
• Last updated: 2021-04-22
• Results posted: 2021-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study