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

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT04468204
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
10.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SinuSonic Device
  • Device: Sham SinuSonic Device
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Symptoms Score (TSS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sinus Center - Medical Univesity of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaun A. Nguyen, Professor, Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT04468204
    Other Study ID Numbers:
    • Pro00100980
    First Posted:
    Jul 13, 2020
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Infections
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Aug 2, 2021