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)

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Infection
• Intervention / Treatment: Device: SinuSonic Device; Device: Sham SinuSonic Device

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Sinus Center - Medical Univesity of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: Pro00100980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not Applicable. The investigators plan to publish this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No