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

NCT04468204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-12-20

Study results available
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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

Interventions

DEVICE

SinuSonic Device

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

DEVICE

Sham SinuSonic Device

Sham positive expiratory pressure intervention using the SinuSonic Device.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-06-30
Completion
2021-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468204 on ClinicalTrials.gov