NCT04468204

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

Completed NA Results posted Last updated 20 December 2022

What this trial tests

NA trial testing SinuSonic Device in Upper Respiratory Infection in 95 participants. Completed in 1 July 2021.

Timeline

1 October 2020

Primary endpoint
30 June 2021

1 July 2021

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	95
Start date	1 October 2020
Primary completion	30 June 2021
Estimated completion	1 July 2021
Sites	1 location across United States

Drugs / interventions tested

• SinuSonic Device
• Sham SinuSonic Device

Conditions studied

• Upper Respiratory Infection — all drugs for Upper Respiratory Infection →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Upper Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Symptoms Score (TSS) Primary · 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.

Group	Value	95% CI
SinuSonic Device	0.503	± 0.501
Sham	0.843	± 0.569

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SinuSonic Device

Serious: 0/39 (0%)

Deaths: 0/39

Sham

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (1 terms — click to expand)

Reaction	System	SinuSonic Device	Sham
Pain	Ear and labyrinth disorders	—	—

Data from ClinicalTrials.gov NCT04468204 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of sinus headache using a device that combines acoustic vibration with oscillating expiratory pressure.
   Miglani A, Germroth M, LaPointe KA, Nguyen SA, et al · · 2023 · cited 4× · PMID 37621300 · DOI 10.1002/lio2.1124