SinuSonic Announces Presentation of Double-Blind, Sham-Controlled Trial Data Showing Regular Use of the Device Improved Nasal Congestion

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Columbia, S.C., May 5, 2022 — SinuSonic is pleased to announce presentation of the results from their study on “Double-blind, sham-controlled trial of a novel device for the treatment of viral upper respiratory tract infection”. This study was an oral podium presentation at the American Rhinological Society Spring meeting in Dallas, TX on April 28-29, 2022. This study showed with the highest level of evidence, a randomized sham controlled study, that regular use of the active SinuSonic device improved nasal congestion.

The prospective study was conducted at the Medical University of South Carolina in 2020-2021. Administration of acoustic vibration and oscillating expiratory positive pressure with SinuSonic has been shown in a prior study to improve nasal congestion and air flow. These interventions are hypothesized to release nasal nitric oxide, a molecule with known antiviral properties. The current study investigated the use of this device to prevent viral upper respiratory infections (URI) and reduce the severity and duration of rhinologic symptoms.

Asymptomatic community dwelling adults were randomized to receive an active or a sham device (3:1). Subjects used the assigned device twice daily beginning at the start of the fall URI season. A validated metric of viral URI symptoms, Total Symptoms Score (TSS), was assessed each day for 8 weeks.

Topline outcomes:

  • Those using the active device had 70% more days with no nasal congestion (57.2% vs 33.5%, p = 0.033)
  • A statistically significant difference in nasal congestion score was seen between the active and sham groups (0.503 vs. 0.843, p = 0.036)
  • No subject in either the active or sham group developed symptoms meeting the study definition of a viral URI, likely due to viral precautions during the pandemic.
  • No major adverse events detected, with 97.5% of subjects reporting zero pain or discomfort at study conclusion. 

 

ABOUT NASAL CONGESTION

Chronic nasal congestion impacts roughly 20% of the population and is associated with reduced quality of life, difficulty sleeping, reduced daytime performance, and increased healthcare utilization. It has been estimated that the financial impact of chronic nasal congestion is more than $5 –10 billion annually. A survey conducted by Allergies in Americas found that despite the availability of pharmacologic options, many patients are not satisfied with available options. 

 

ABOUT SINUSONIC

Founded in Columbia, South Carolina, and born through the research and partnerships of Richard K. Bogan, MD and David J. Lewis, SinuSonic is the first-ever multi-patented (5) nasal congestion relief device to use acoustic vibrations to help provide nasal congestion relief. SinuSonic is designed in the U.S. with parts molded in the U.S. and assembled in an FDA-registered facility in Columbia, South Carolina. Since launching in July 2019, SinuSonic is being used in all 50 states. For more information and to view instructional videos, visit sinusonic.com

SinuSonic is available to the public at www.sinusonic.com


Media Contact:

David Lewis
Info@SinuSonic.com (803) 888-6170

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