CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
SinuSonic Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04468204
NCT04468204N/ACompleted

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

Medical University of South Carolina·interventional·Posted Jul 13, 2020·Updated Dec 20, 2022

In Brief

A clinical study evaluating SinuSonic Device and Sham SinuSonic Device for Upper Respiratory Infection. Completed, enrolled 95 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 13, 2020
Enrollment StartOct 1, 2020
Primary CompletionJun 30, 2021
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.0 years ago

Interventions

SinuSonic Devicedevice

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

Sham SinuSonic Devicedevice

Sham positive expiratory pressure intervention using the SinuSonic Device.