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

Primary Purpose

Upper Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SinuSonic Device
Sham SinuSonic Device
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sinus Center - Medical Univesity of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SinuSonic Device

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2020
Last Updated
November 22, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04468204
Brief Title
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
Official Title
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SinuSonic Device
Arm Type
Experimental
Arm Description
SinuSonic device used for 1 min three times a day for 8 weeks.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham SinuSonic device used for 1 min three times a day for 8 weeks.
Intervention Type
Device
Intervention Name(s)
SinuSonic Device
Intervention Description
A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
Intervention Type
Device
Intervention Name(s)
Sham SinuSonic Device
Other Intervention Name(s)
Sham
Intervention Description
Sham positive expiratory pressure intervention using the SinuSonic Device.
Primary Outcome Measure Information:
Title
Total Symptoms Score (TSS)
Description
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.
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sinus Center - Medical Univesity of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not Applicable. The investigators plan to publish this study.

Learn more about this trial

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

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