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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Respiratory Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SinuSonic Device

Device

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

Sham SinuSonic Device

Device

Sham positive expiratory pressure intervention using the SinuSonic Device.

Other names: Sham

Primary outcomes

Total Symptoms Score (TSS)

Time frame: 60 Days

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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 13, 2020
Registry last updated: Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed