Status:
COMPLETED
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
Lead Sponsor:
Medical University of South Carolina
Conditions:
Upper Respiratory Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sou...
Eligibility Criteria
Inclusion
- Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.
Exclusion
- Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
- Any upper respiratory illness within last 2 weeks
- TSS will be measured at baseline as described above and must be \<9 for inclusion (Eccles etal).
- Topical decongestant use in last week
- Current nasal crusting or history of ulceration or perforation
- History of severe nose bleeding within last 3 months
- Known pregnancy
- Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy
- Allergic sensitivity to silicone or any other component of device
- Inability to read and understand English
- Inability to perform treatment due to underlying medical condition
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04468204
Start Date
October 1 2020
End Date
July 1 2021
Last Update
December 20 2022
Active Locations (1)
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1
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, United States, 29425