Effects of SinuSonic on Psychological and Physical Well-Being In Adults With Nasal/Sinus Congestion
Phase: NA
Conditions: Nasal Congestion and Inflammations, Sinus Congestion Chronic
Sponsor: University of North Carolina, Chapel Hill

 
Effects of SinuSonic on Psychological and Physical Well-Being 
 
 
 
NCT number NCT06268730 
Document Date 12/26/2023 
 

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Effect of the SinuSonic Device on Psychological and Physical Well-Being in Adults with Nasal/Sinus 
Congestion 
PI (UNC):  Keri J. Heilman, PhD 
Brief background:  Chronic nasal congestion impacts the functioning of the ventral vagal complex (VVC), 
which includes cranial nerves of the face and head (special visceral efferents), along with vagal 
regulation of the heart and lungs.  Physiological compromise of the VVC due to a current or previous 
adverse experience may allow for worsening nasal congestion, which then has a circular impact back to 
poorer vagal regulation of the lungs.   
 
This chronic cycle of congestion and poor vagal regulation can likewise impact mental health.  Defensive 
symptoms/behaviors, such as anxiety and depression, are common emergent symptoms of a 
compromised VVC. 
 
Purpose:  The first aim of the study is to evaluate relationships between current/previous adverse 
events, degree of nasal congestion, perception of autonomic regulation and symptoms of anxiety and 
depression via self-report questionnaires. 
 
The second aim of the study is to evaluate the effect of the SinuSonic on physical and psychological well-
being in individuals with chronic nasal congestion.  The SinuSonic is a self-applied nasal device designed 
to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic 
vibration and gentle oscillating expiratory pressure.  The vibration and expiratory pressure stimulate 
several cranial nerves that are included in the ventral vagal complex (VVC), including the cranial nerves 
of the face and head (special visceral efferents).  According to the Polyvagal Theory (Porges, 1995, 1998, 
2001, 2003, 2007), when the VVC is stimulated, the functioning of related cranial nerves and emergent 
behaviors should improve, supporting a calmer, more regulated nervous system, and improved mental 
health.   
 
To evaluate the effects of the SinuSonic, self-report questionnaires will be administered (via RedCap) 
prior to beginning use of the SinuSonic, weekly during directed use of the SinuSonic (2 minutes per day, 
2 times per day), and after 5 weeks of use of the SinuSonic.   Weekly self-report questionnaires will 
include amount of SinuSonic usage and degree of nasal congestion.  The final, 5-week questionnaires 
will include degree of nasal congestion, perception of autonomic regulation and symptoms of anxiety 
and depression. 
As this is a feasibility/pilot study, data from the study will be used to estimate effect sizes and inform a 
larger, randomized trial on the effects of the SinuSonic on individuals with compromised autonomic 
regulation, if warranted by the results.  
 
 
 

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Background:  The SinuSonic was developed as a non-phamaceutical device aimed to reduce nasal 
congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory 
pressure.  Previous studies have demonstrated significant improvements in congestion and ease of 
breathing after immediate use of the device (Cairns & Bogan, 2019) and after twice daily use for 5-
weeks (Soler et al., 2020).  In this study, there was significant improvement in peak nasal inspiratory 
flow after only 2 weeks of use, and significant improvement in multiple self-report measures of 
congestion after 5 weeks of use.  No adverse effects were reported.  A review report by Schlosser, Salley 
and Soler likewise concluded that the device may improve pregnancy-related rhinitis, which may be 
particularly important for individuals who would prefer non-pharmacological interventions while 
pregnant or breastfeeding (https://sinusonic.com/blogs/learn/pregnancy-rhinitis.) 
 
There are common clinical symptoms, such as anxiety and depression, that are frequently associated in 
individuals who feel unhealthy. The Polyvagal Theory (Porges, 1995, 1998, 2001, 2003, 2007) provides a 
model for which these psychological and physical symptoms may be viewed as the predictable 
consequences of a common neural substrate.  This neural substrate involves the neural regulation of the 
heart and lungs, as well as neural regulation of the muscles of the face and head which function 
together as a Ventral Vagal Complex (VVC). 
The VVC is based on the documented neuroanatomical and neurophysiological pathways between the 
brainstem areas that regulate the muscles of the face (via special visceral efferent pathways) and the 
heart and lungs (via the vagus). Features of the VVC may serve as a clinical checklist converging on 
symptoms of anxiety and depression as observed in several clinical disorders including autism (Bal et al., 
2010; Patriquin et al., 2011; Porges et al., 2012; Van Hecke et al., 2009), Fragile-X-Syndrome (Heilman et 
al., 2011), selective mutism (Heilman et al., 2012), prematurity (Doussard-Roosevelt, et al., 1997),  
prenatal exposure to opiates and alcohol (Suess et al. 1997), PTSD (Sahar et al., 2001), perpetrators of 
domestic abuse (Umhau et al., 2002), Borderline Personality Disorder (Austin et al., 2007), behavioral 
regulation problems (Dale et al., 2011), and abuse and neglect (Dale et al., 2009).  However, relating 
symptoms of anxiety and depression to an illness that impacts the functioning of the VVC (i.e., nasal 
congestion impacts the functioning of the vagus at the lungs) is a novel aspect of the current study.   
Additionally, individuals who already have a compromised VVC due to adverse events (history or 
current), may also be at risk for the continued cycle of VVC complications (i.e., chronic congestion, 
anxiety and/or depression).   
In summary, the function of the SinuSonic (i.e., reducing nasal congestion while improving vagal 
regulation of the lungs) align with the theoretical principles of the Polyvagal Theory.  Thus, our proposed 
research will serve to determine whether the SinuSonic will have a significant impact on the reduction 
and management of physical and psychological symptoms (i.e, anxiety and depression), as they are 
described within the context of a dysregulated VVC.   
 
 
 
 
 

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Flowchart of Research Procedures: 
 
 
Participants 
50 adults (aged 18-99 years) with self-reported nasal congestion will be recruited for the study.  
Participants must be US residents. 
 
Data Collection Procedures 
Step 1:  Recruit/Eligibility Screening 
Individuals who make a purchase of the SinuSonic device will receive a recruitment flyer in the shipping 
box for their device, but only new users of the SinuSonic will be eligible to participate.  The recruitment 
flyer will contain a QR code that users can scan to access the Eligibility Screening for the study in 
RedCap.  Staff at SinuSonic has agreed to include the recruitment flyer when shipping packages. 
The Eligibility Screening will consist of the following questions: 
1) Are you between ages 18-99 years old?  [YES TO QUALIFY] 
2) Have you ever used the SinuSonic device?  [NO TO QUALIFY] 
3) Do you meet any of the conditions listed under the Safety and Warnings for use of the SinuSonic 
device?   [NO TO QUALIFY] 
a) Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary 
disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, 
cancer of the throat or upper airway) 
Beginning of Study (week 0)
•Demographic information
•Health information
•Short-Form Health Survey (SF12)
•Total Nasal Symptom Score (TNSS)
•Body Perception Questionnaire (BPQ)
•Hospital Anxiety and Depression Scale 
(HADS)
•Adverse Traumatic Experiences Scale 
(ATES)
Weekly 
(1, 2, 3, 4)
•Patient 
Global 
Impression 
of Change 
(PGIC)
•TNSS
•SinuSonic 
usage form
End of Study 
(week 5)
•PGIC
•TNSS
•SinuSonic 
usage form
•BPQ
•HADS

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b) Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary 
artery disease, congestive heart failure, heart attack) 
c) Other conditions, specified as brain tumor, moderate to severe ear pain, fever greater than 
101 degrees 
4) Have you experienced symptoms of nasal congestion that have persisted at least 2 weeks? [YES 
TO QUALIFY] 
5) Is your current level of nasal congestion at 5 or higher?  (VAS included here) [YES TO QUALIFY] 
Step 2:  Consent/Linkage File 
When all eligibility criteria are met, individuals will be invited to access the Informed Consent document 
(also provided via RedCap) to read and e-sign.  Phone number and email address for the researcher will 
be provided in the event of questions or request for clarification. 
After receiving the e-signed informed consent, researchers will assign a SubjectID number so that the 
participant can use the SubjectID number when completing all questionnaire assessment sessions using 
RedCap.  Researchers will maintain a database linking SubjectID and name on their password-protected 
computers that will not be accessible to anyone who is not affiliated with the research. 
Step 3:  Pre-SinuSonic assessment 
Participants will be asked to complete this assessment, via RedCap, prior to beginning use of the 
SinuSonic.  Researchers will provide participants with a link to the assessment (text or email), along with 
their unique SubjectID number to use.  The following instruments will be programmed into RedCap for 
completion: 
Prior to SinuSonic Use (week 0): 
1) Demographic Information Form 
2) SF12 to assess overall health (“how you feel and how well you are able to do your usual 
activities”) 
3) TNSS to assess current nasal symptoms 
4) BPQ to reflect perception of autonomic regulation 
5) HADS to assess anxiety and depression 
6) ATES to assess history of trauma/adverse events 
Step 4:  SinuSonic Use / Weekly assessments 
After completing the pre-SinuSonic assessment, researchers will inform participants to begin directed 
use of the SinuSonic (2 minutes per day, 2 times per day).  Participants will be asked to confirm 
SinuSonic use on a weekly questionnaire.  Additionally, participants will be asked to complete the 
following questionnaires approximately 5 minutes after final SinuSonic use for that week.  The following 
instruments will be programmed into RedCap for completion: 
 

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Weekly, for 4 weeks (end of week 1, 2, 3, 4).   
1) TNSS to assess current nasal symptoms 
2) PGIC to reflect change in activity limitations, symptoms, emotions and overall quality of life 
Step 5:  Final research assessment 
Participants will be asked to confirm use of the SinuSonic on a weekly questionnaire.  Additionally, 
participants will be asked to complete the following questionnaires approximately 5 minutes after final 
SinuSonic use on the 5th consecutive week.  The following instruments will be programmed into RedCap 
for completion: 
End of Study (end of week 5).   
1) TNSS to assess current nasal symptoms 
2) PGIC to reflect change in activity limitations, symptoms, emotions and overall quality of life 
3) BPQ to reflect perception of autonomic regulation 
4) HADS to assess anxiety and depression 
Description of Measures 
Body Perception Questionnaire (BPQ) (Cabrera et al., 2018). The Body Perception Questionnaire (BPQ) is 
a self-report measure of body awareness and autonomic reactivity. Its items are based on the 
organization of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and 
body. These pathways send information from the body about the status of organs and tissues (i.e., 
afferent projections). Some of these incoming signals form a basis for the subjective awareness of the 
body. The ANS also carries signals that control the functions of these organs and tissues (i.e., efferent 
projections). These signals can alter the functions of the body, depending on internal and external 
needs.  Only the Autonomic Reactivity subscale will be distributed and used for the current study. 
Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983).  HADS is a fourteen-item scale 
with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to 
three. A subscale score >8 denotes anxiety or depression. 
Short-Form Health Survey-12 (Ware et al., 1995).  The SF-12 is a health-related quality-of-life 
questionnaire consisting of twelve questions that measure eight health domains to assess physical and 
mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), 
Role Physical (RP), and Body Pain (BP) 
Total Nasal Symptom Score. The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal 
congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0–3), 
where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for 
awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that 
are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of 
the symptoms to a total out of 12.  
Adverse Traumatic Experiences Scale (ATES) (Kolacz et al., 2020).  This measure asks about childhood 
adverse experiences, childhood maltreatment, other person maltreatment, life-threatening situations, 
sudden deaths of close ones, and personal health situations. Respondent-reported prior adverse events 

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of maltreatment, life-threatening situations, and sudden deaths of close ones are summed to create an 
adversity score (range: 0–19). 
Patient Global Impression of Change (PGIC) (Hurst & Bolten (2004).  The self-report measure Patient 
Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 
point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much 
improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” 
or “very much worse.”  
Data Analyses 
Questionnaire data will be entered by participants into RedCap for researcher access. Researchers will 
export the data into SPSS for data analyses. All databases will be stored on password protected 
computers, accessible only to researchers affiliated with the study, and backed up on UNC servers.  
As the current proposal is for a feasibility/pilot study, researchers will evaluate the following aims to 
determine whether a larger, randomized trial is warranted.  
Aim 1:  Examine associations between nasal congestion, autonomic functioning, adverse events, and 
mental health indices (depression, anxiety) at baseline. Pearson correlation analyses will be used to 
evaluate relationships among measures at each timepoint.  
Aim 2: (These would be the aims for a future, randomized clinical trial, with preliminary testing using 
data from the current feasibility/pilot study): Evaluate the effect of the SinuSonic on users with chronic 
nasal congestion. We will focus on three constructs important to psychological and physical health and 
hypothesize that:  
A) Nasal congestion will significantly improve when comparing baseline measures to follow-up 
measures at each week, and will maintain effects at 5 weeks. Repeated measures ANOVA will be 
used to evaluate mean change in outcome measures across time in PGIC and TNSS.  
B) Autonomic functioning will significantly improve when comparing baseline measures to end 
of study.  Repeated measures ANOVA will be used to evaluate mean change in BPQ across time.  
C) Mental health indices (depression, anxiety) will significantly improve when comparing 
baseline measures to end of study.  Repeated measures ANOVA will be used to evaluate mean 
change in HADS across time.  
Aim 3: (This would be an aim for a future, randomized clinical trial, with preliminary testing using data 
from the current feasibility/pilot study).  Evaluate the mediating effect of current/previous adverse 
experiences on outcome measures at 5 weeks, using regression models. 
Aim 4: Calculate effect sizes for each outcome variable, which will be necessary to determine adequate 
sample size for a future clinical trial. G-Power software will be used to determine sample sizes based on 
the effect sizes of the current outcome measures. 
 

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