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

NCT04468204 | Completed Results FDA Device

• 1 other identifier: Pro00100980
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SinuSonic Device

EXPERIMENTAL

SinuSonic device used for 1 min three times a day for 8 weeks.

Device: SinuSonic Device

Sham

SHAM COMPARATOR

Sham SinuSonic device used for 1 min three times a day for 8 weeks.

Device: Sham SinuSonic Device

Interventions

SinuSonic Device DEVICE

A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.

SinuSonic Device

Sham SinuSonic Device DEVICE

Sham positive expiratory pressure intervention using the SinuSonic Device.

Also known as: Sham

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
• Any upper respiratory illness within last 2 weeks
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Department of Otolaryngology - Head and Neck Surgery

nguyensh@musc.edu

(843)792-1356

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 1, 2021
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)