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

Upper Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468204
• Other study ID #: Pro00100980
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infections
• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

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

Locations

Country	Name	City	State
United States	Sinus Center - Medical Univesity of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Symptoms Score (TSS)	The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.; The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.; The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms); Minimum score=0; maximum score=27.	60 Days