A User Study of the Soniflow System for Nasal Congestion Relief
Phase: NA
Conditions: Nasal Congestion
Sponsor: Third Wave Therapeutics

 
NCT04910139: A User Study of the Soniflow System for Nasal Congestion Relief 
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Title: A User Study of the Soniflow System for Nasal Congestion Relief 
 
NCT Number: NCT04910139 
 
Date: March 5, 2020 
 
Sponsor: Sound Health Systems 
 
 

 
NCT04910139: A User Study of the Soniflow System for Nasal Congestion Relief 
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1. STUDY PROTOCOL  
 
1.1 Objectives  
This study was designed to evaluate the safety and efficacy of the Soniflow System for the 
treatment of nasal congestion.  
 
1.2 Study Design  
This study is a prospective, single-center, interventional cohort study of acoustic resonance 
therapy (ART) for the treatment of nasal congestion using the Soniflow System. Subjects 
with nasal congestion as determined by the Total Nasal Symptom Score (TNSS) were 
consented and screened for study eligibility (score of 2 or 3 on the nasal congestion 
subdomain). Eligible subjects who consented to the study were mailed the device as well as 
provided a link to download the associated smartphone app. Subjects self-performed the 
treatment without assistance from the staff after reading the included instructions. The 
intervention consisted of two sequential 10-minute treatment sessions, with treatment time 
automatically tracked by the app. Subjects reported their baseline TNSS, including 
subscores for each of the 4 subdomains, prior to any intervention and immediately after 
each of the two 10-minute treatment sessions. In order to assess whether use of the 
product led to pain or discomfort, visual analog scales (VAS) for headache and facial pain 
were assessed at baseline and after each treatment session, with higher scores indicating 
increased symptom burden.  
 
1.3 Study Endpoints  
Safety and efficacy were evaluated by the following primary and secondary endpoints.  
Primary Endpoints  
• 
Safety as evidence by an assessment of serious acute serious adverse events 
potentially associated with device 
• 
Effectiveness as defined by improvement in nasal symptoms using the TNSS after 
one 10 minute treatment 
• 
Use-ability for self-treatment 
 
Secondary Endpoints  
• 
Visual Analog Scale (VAS) for Headache 
• 
Visual Analog Scale (VAS) for Facial Pain 
• 
Percent of subjects requiring additional treatment and their subsequent change in 
TNSS 
 
2. STATISTICAL PLAN  
Descriptive statistics and graphical summaries were used to summarize the data. For 
categorical variables, counts and percentages were calculated. For continuous variables, 
means, standard deviations or standard error were calculated. Changes in symptom scores 
and nasal congestion from baseline were evaluated using a paired t-test examining the 
distribution of within-patient changes from baseline to each of the two post-treatment 
intervals. A clinically meaningful change in TNSS from baseline was defined as the minimal 
clinically important difference (MCID) identified using anchor-based methods in allergic 
rhinitis, with a value of 0.28.