NCT04468204

Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)

Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (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, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.

Conditions

• Upper Respiratory Infection

Interventions

Type	Name	Description
DEVICE	SinuSonic Device	A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
DEVICE	Sham SinuSonic Device	Sham positive expiratory pressure intervention using the SinuSonic Device.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-06-30
• Completion: 2021-07-01
• First posted: 2020-07-13
• Last updated: 2022-12-20
• Results posted: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study