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

Study Overview
=================
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 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.

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

Conditions
-----------------
Upper Respiratory Infection

Intervention / Treatment
-----------------
* Device: SinuSonic Device
* Device: Sham SinuSonic Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SinuSonic Device<br>SinuSonic device used for 1 min three times a day for 8 weeks. | Device: SinuSonic Device<br>* A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.<br>|
| Sham Comparator: Sham<br>Sham SinuSonic device used for 1 min three times a day for 8 weeks. | Device: Sham SinuSonic Device<br>* Sham positive expiratory pressure intervention using the SinuSonic Device.<br>* Other names: Sham;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |