Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
Phase: NA
Conditions: Upper Respiratory Infection
Sponsor: Medical University of South Carolina

 
 
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PROTOCOL TITLE: 
Use of novel Sinusonic device for prevention of community acquired  
upper respiratory infection (URI) 
The study will be conducted in compliance with the clinical study protocol, international 
good clinical practice principles (International Conference on Harmonization [ICH]-
Good Clinical Practice [GCP]), and regulatory authority requirements. 
PRINCIPAL INVESTIGATOR: 
 
 
Dr. Ted A. Meyer and Dr. Shaun Nguyen 
 
 
 

 
 
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1.0   
Objectives / Specific Aims:  
Sinusonic is a simple handheld device that uses acoustic vibrations (128Hz) and positive 
expiratory pressure as patients exhale through their nose. Beneficial effects have been 
shown in a clinical trial studying chronic rhinitis that showed improvements in nasal 
blockage/congestion, nasal drainage, nasal/sinus pressure and sense of smell (Soler ZM 
etal available at https://onlinelibrary.wiley.com/doi/full/10.1002/alr.22537). A small 
unpublished pilot study demonstrated >70% increases in peak nasal nitric oxide (NO) 
after one use of Sinusonic.  NO is known to stimulate mucociliary clearance and has 
antiviral properties. Given that Sinusonic improves nasal congestion, nasal drainage and 
appears to increase NO which has antiviral properties, our hypothesis is that use of 
Sinusonic will decrease the frequency, severity and duration of community acquired viral 
URIs.  
Aim 1: To determine 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 three times a day for 8 
weeks. Daily URI symptoms will be recorded electronically. 
Aim 2: To determine if Sinusonic decreases the severity and duration of 
community acquired viral URIs. Subjects will use active or sham device as 
above. Severity and duration of URIs will be recorded using daily symptom 
diaries.  
 
 

 
 
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2.0 
Background 
 
Sinusonic is a simple 
handheld device that uses 
acoustic vibrations 
(128Hz) and positive 
expiratory pressure as 
patients exhale through 
their nose. Beneficial 
effects have been shown 
in a clinical trial that 
showed improvements 
in nasal 
blockage/congestion, 
nasal drainage, 
nasal/sinus pressure and 
sense of smell (Soler 
ZM, etal). Some of these benefits occurred after one use of the device and these benefits 
continued to increase throughout the 5 week study.  In this clinical trial, approximately 80% of 
patients demonstrated improvement. A small unpublished pilot study demonstrated >70% 
increases in peak nasal NO after one use of Sinusonic.  Our hypothesis is that use of Sinusonic 
improves nasal congestion, mucociliary clearance and exhaled NO, all of which decrease viral 
infections. 
 
3.0 
Intervention to be studied 
 
Subjects will be screened for likely inclusion during the summer months. Baseline 
demographics, medical comorbidities, and URI symptoms will be assessed. Informed consent 
will be completed.  
 
The fall URI season typically runs through September and October (Turner R etal). Towards the 
end of screening, all subjects will be randomized 2:1 to active use of Sinusonic (128Hz) for 1 
minute 3 times daily or an identical “placebo” device that emits a frequency of 1,000 Hz and has 
the ball valve modified to eliminate positive expiratory pressure. Devices will be shipped to 
home addresses via overnight mail. On September 1, 2020 all subjects will begin daily use of 
their assigned device. Subjects will remain blinded as to treatment arm until study completion. 
Subjects will be asked to complete a brief daily questionnaire on URI symptoms and 
whether or not they feel as if they have a “cold”. Previously validated questions for viral 
URI studies are rating 8 items on a likert scale from 0 (no symptoms) to 3 (severe 
symptoms) (Jackson GG, etal). The 8 symptoms are: sneezing, runny nose, nasal 
obstruction, sore throat, cough, headache, malaise, and chilliness. A Total Symptom 
Score (TSS) will be the sum of each symptom to provide a daily score ranging from 0 to 
24. Prior studies have defined the common cold as present when: 
1) TSS > 14 PLUS moderate or severe nasal discharge x 3 days OR patient 
subjective impression they have a cold OR 
0%
10%
20%
30%
40%
50%
60%
70%
80%
Calculated
Range
Start + 10s Start+20s
Start+30s
Peak
Peak+5s
Peak+10s
% increase over resting nNO
64Hz ave
110-146Hz ave
256-4000Hz ave

 
 
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2) TSS < 14 AND moderate or severe nasal discharge x 3 days AND subjective 
impression they have a cold 
Answers will be uploaded to secure REDCAP database. The study duration is 8 weeks. 
At the end of the study, subjects will be asked questions regarding device safety and 
tolerability. 
Our primary outcome will be absolute number of URIs experienced during the 8 week 
study period. Secondary outcomes will be time to first URI, duration and symptom 
severity of viral URIs. These metrics will allow us to determine if Sinusonic decreases 
the frequency of URIs, as well as potentially shortening the duration or decreasing the 
severity of URIs. 
3.1 
Device Instructions 
 
Instructions for use: 
1. Hold the SinuSonic device at a 45-degree angle 
2. Deep breathe in through mouth  
3. Hold the SinuSonic to your nose and blow out into the 
mask of the SinuSonic. The goal here is to hear the 
“target flutter” sound that is desired during treatment 
with the SinuSonic 
4. You will feel a little resistance to breathe out and a 
vibration sensation from a speaker in the device 
5. Remove the device to “blow the nose” if nasal drainage 
occurs 
6. Return the device to the nose then breathe in and out thru the nose to try and hear 
the “target flutter” sound  
7. Time of use is 1 minute of nasal breathing with the device - as tolerated 
8. Goal is to use Sinusonic 3 times per day with uses separated by at least 5 minutes. 
3.2 
Device Usage and Safety 
 
The SinuSonic consists of a fully-disposable medical grade silicone nosepiece mounted to a resin 
body. The device is equipped with a flutter valve located at the top of the device which creates 
gentle, self-guided oscillating expiratory resistance. 
 
The SinuSonic is a legally marketed device used in accordance with its labeling.  It is 
substantially equivalent to many Class I OTC devices with the same intended use and indications 
for use in clearing mucus to improve air flow, such as the Navage Nose Cleaner. 
 
 
4.0 
Inclusion and Exclusion Criteria/Study Population 
Inclusion Criteria  
• Adults 18 years or older with no transient symptoms of any URI or allergies at baseline. 
Exclusion Criteria 

 
 
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Any transient ENT condition that may impact upper airway to include acute sinusitis or 
otitis. 
 
Any upper respiratory illness within last 2 weeks 
TSS will be measured at baseline as described above and must be <9 for inclusion 
(Eccles etal). 
Topical decongestant use in last week 
Current nasal crusting or history of ulceration or perforation  
History of severe nose bleeding within last 3 months 
Known pregnancy 
Immunosuppressed condition or on immune modulating medications such as prednisone 
or chemotherapy 
Allergic sensitivity to silicone or any other component of device 
Inability to read and understand English 
Inability to perform treatment due to underlying medical condition 
 
After confirming that subjects meet inclusion criteria, they will be entered into study as 
outlined below.  Subjects who have URI symptoms at the beginning of the study will 
specifically be excluded, as the purpose of the study is prevention of URIs, not treatment 
of pre-existing URIs. 
4.1 COVID19 
The purpose of the study is to see if Sinusonic prevents community acquired viral URIs, 
not to treat existing infections. So patients must be asymptomatic at the beginning of 
study. As this study is not conducted exclusively on MUSC patients and is being done 
virtually (to minimize exposure and increase safety during the covid pandemic), we do 
not have the ability to perform widespread covid testing on hundreds of asymptomatic 
patients. So it is possible that someone will have undiagnosed covid. 
 
5.0 
Number of Subjects 
 
Prior research reports (Turner etal) using identical outcome measures and studying community 
acquired URIs in the fall season report that approximately 60% of subjects suffered from a viral 
URI (range 48% to 75% in each arm). We are planning to include 300 subjects (200 active 
device, 100 sham device). If we conservatively assume that only 50% of sham device subjects 
get an URI, we will be powered to detect a decrease to 33%.  
 
6.0 
Setting 
Research will be conducted at geographical locations in the Southeast (SC, NC, GA, VA) 
that have similar fall viral URI seasons.  Potential participant screening for all subjects 
across all aims, as well as informed consent and baseline evaluations, will occur remotely 
to avoid any risk to research personnel.  All baseline and follow-up measures will be 
collected remotely using REDCap at 4 and 8 weeks.   
7.0 
Recruitment Methods 

 
 
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We will publicize the study through MUSC and Sinusonic social media targeting 
geographic regions described above. A number and email will be provided for subjects 
interested in participating. Only one subject per household can be enrolled. 
8.0 
Consent Process 
Patients who respond to social media recruitment will be contacted by study personnel to 
determine eligibility. As the goal is to recruit subjects from throughout the southeast, no 
in person visits will be conducted at MUSC and it will be necessary to obtain remote 
informed consent.  
The remote consent process will include an informed consent discussion with the 
potential participant and involve the participant signing and returning the informed 
consent document to the researcher.  The informed consent discussion will occur over the 
phone. The documentation of consent process will include sending the informed consent 
document to the subject for signature and transmitting it back to the research team to be 
signed by the researcher before any research procedures begin. The document will be sent 
using the electronic consent option in REDCap.  
A member of the study team will describe in full detail the study and the informed 
consent form to the potential subject.  The study team member will explain: 
1. What would be different if the patient participated in the study versus receiving 
standard of care treatment. 
2. The study is voluntary participation, patient may withdraw any time, and PI 
may take patient off study at any time. 
3. The reason for doing the study 
4. How many people will be in the study 
5. Who is eligible to participate in the study 
6. Details regarding the study device. 
7. What medical assessments/questionnaires they will have and how often 
8. Risks involved in participating in a study 
 
9. What information will be gathered 
The prospective participant will be given adequate time to review the informed consent 
form and ask any questions that they have before the consent is obtained.  Participants 
will electronically be sent a signed copy of the ICF.  
9.0  
Study Design / Methods 
This study is designed as a pilot study. 
Data will be collected by the study investigators as well as the subjects themselves 
throughout the entirety of the study.  The data will consist of answers from subjects for 
questionnaires asked by the clinicians as well as self-reported answers from the subjects. 
9.1  
Schedule of Events  

 
 
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All subjects (N=300) 
Screening 
Baseline 
assessment 
Study start Study endpoint 
Date 
Up to -30 
Days 
Day 1 
12 Days 
60 
Days 
Informed consent 
X 
 
 
 
Inclusion/exclusion 
criteria 
X 
Reconfirm 
TSS<9 
 
 
Medical history 
X 
 
 
 
Randomization 
(2:1 active:sham) 
 
X 
 
 
Distribution of 
Sinusonic 
 
X 
 
 
Viral URI 
questionnaire 
 
X 
X 
X 
Safety questions 
 
 
 
X 
 
10.0 
Data Management 
All analyses and graphs will be performed with SPSS 24.0, Sample Power 3.0, and Sigma 
Plot 10.0 (SPSS, Chicago, IL.).  Disease information and demographic variables, such as 
age, gender, race, and VAS scores will be summarized using frequencies, means, and 
standard deviation as appropriate.  Our primary outcome metric is number of viral URIs 
as defined above. Secondary outcome metrics include average duration of URIs and 
severity of symptoms (as measured by TSS) of URIs. Categorical variables will be 
compared using Chi Square or McNemar’s test.  Continuous variables will be compared 
using One-Way ANOVA with repeated measures follow by post-hoc analysis.  Data 
regarding safety and patient satisfaction will be summarized for each time point.  A p-
value ≤0.05 will be considered statistically significant.  Due to the exploratory nature of 
this study, no p-value correction (ie Bonferroni) will be applied.   
11.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects  
Safety will be monitored throughout the study based on the monitoring of adverse events, 
via electronic data collection. The period of observation for collection of non-serious 
adverse events extends from the time the subject gives informed consent until the 
completion of the End-of-Study visit or Early Termination Visit.  Serious adverse events 
(SAE) will be reported to the MUSC IRB and to the sponsor from the time of informed 
consent through 30 days after the last use of the SinuSonic.  Adverse event data listings 
will be reviewed by Principal Investigator and the research team at regular intervals 
throughout the study.   
Safety data listings will be reviewed by Principal Investigator, Co-Investigators, and the research 
team at regular intervals throughout the study.   
Safety will be monitored throughout the study based on monitoring of adverse events, and 
through collection of symptoms electronically.  Collection of symptoms will occur via the Daily 
URI Symptoms Score questionnaires that are electronically sent to the consented patients. 

 
 
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The period of observation for collection of non-serious adverse events extends from the time the 
subject gives informed consent until completion of the End-of-study visit or Early Termination 
Visit. Serious adverse events (SAE) will be reported to the IRB and to the sponsor from the time 
of informed consent through 30 days after the last use of the SinuSonic. Adverse event data 
listings will be reviewed by the principal investigator, co-investigators, and the research team at 
regular intervals throughout the study. 
All AEs, regardless of seriousness or relationship to SinuSonic use, spanning from the signature 
of the informed consent form until the end of the study as defined by the protocol for that patient, 
are to be reported to the Healthy Humming, LLC. All AEs which follow the IRB qualifications 
will also be reported to the IRB within 24 hours of site knowledge of the event.  
The Investigator will take appropriate measures to follow all AEs until clinical recovery is 
complete and laboratory results have returned to normal, or until progression has been stabilized, 
or until death, in order to ensure the safety of the patients. This may imply that observations will 
continue beyond the last timepoint per protocol, and that additional investigations may be 
requested by the monitoring team up to as noticed by Healthy Humming, LLC. 
In the case of occurrence of an SAE, the Investigator will immediately (within 24 hours) report 
the event to Healthy Humming, LLC and to the IRB, as applicable. 
12. Withdrawal 
At any point during the study, a subject may withdraw from the study.  The subject may 
refuse to take part in or stop taking part in this study at any time. The subject will be 
instructed to call the investigator in charge of this study if they decide to do this. Their 
decision not to take part in the study will not affect their current or future medical care or 
any benefits to which they are entitled.  If they wish to withdraw, they will be provided 
contact details for the study team to initiate their withdrawal. 
Early termination from the study is also subject to the PI’s discretion.  Subject will no 
longer be in the study and data will no longer be collected.  The reasons for this 
withdrawal could be due to study non-compliance or if the subject no longer meets 
eligibility requirements.  A member of the study team will notify the study participant if 
they will no longer be participating in the study. 
13.0 
Risks to Subjects 
There are risks to subjects using the SinuSonic device.  Subjects may experience a degree 
of discomfort, nosebleeds or crusting due to use of the device.  Prior studies have 
reported: Mild discomfort in 2.5-5% of patients; Bleeding in 0% of patients; Crusting in 
0% of patients (Soler ZM etal).  
There is a risk of a loss of confidentiality of your personal information as a result of 
participation in this study. 
 
14.0 
Potential Benefits to Subjects or Others 

 
 
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This study is for research purposes only.  Participants may benefit from decreased infections 
with potentially milder symptoms or shorter duration, but we do not know if this will occur.  
Information learned from the study may help other people in the future.   
15.0 
Sharing of Results with Subjects 
Information about the subjects (including identifiable private information) may have all 
of their identifiers removed and used for future research studies.   
Records of the subjects’ participation in this study will be held confidential except as 
disclosure is required by law or as described in the ICF. 
16.0 
Payment 
For participating in this study, participants will be given a free device, but no payment 
will be given.   
17.0 
Devices  
Dispensing and storage of SinuSonic devices will be done by the study sponsor.   
18.0  Data safety monitoring and reporting 
Patients will initially be screened over the phone and informed consent obtained. This 
will occur during the summer months so we have a group of 300 subjects who pass this 
initial screen. Towards the end of the screening period, we will re-contact patients to 
confirm their interest in participation. As described above, we will also ask symptom 
scores to ensure TSS<9 and patient does not have an active URI at the start of the study.  
If patients still wish to participate and still meet inclusion criteria, they will be 
randomized and devices shipped out within a week. 
Safety will be monitored throughout the study based upon self reporting of symptoms. 
Subjects will be advised to seek medical care if at any time their symptoms become 
severe. Review of the daily reports will occur weekly to ensure the condition of each 
patient is adequately monitored for possible signs of URI or COVID19. 
The period of observation for collection of non-serious adverse events extends from the 
time the subject gives informed consent until completion of the End-of-study visit or 
Early Termination Visit. Serious adverse events (SAE) will be reported from the time of 
informed consent through 30 days after the last use of the SinuSonic. Adverse event data 
listings will be reviewed at regular intervals throughout the study.  In addition, 
investigators will be alerted of Adverse Events of interest via automated emails 
programmed in the EDC system. Patient compliance will be assessed via weekly phone 
calls from study coordinator. 
 
 
 
 

 
 
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References 
Soler ZM, Nguyen SA, Salvador C, Lackland T, Desiato VM, Storck K, Schlosser RJ. Safety and 
efficacy of a novel device combining acoustic vibration with oscillating expiratory pressure for 
the treatment of nasal congestion. Int Forum Allergy Rhinol2020;00:1-9. 
 
Turner RB, Fuls JL, Rodgers ND, etal. A randomized trial of the efficacy of hand disinfection for 
prevention of rhinovirus infection. Clinical Infectious Disease 2012;54(10):1422-6. 
 
Eccles R, Winther B, Johnston SL, etal. Efficacy and safety of iota-carrageenan nasal spray vs 
placebo in early treatment of the common cold in adults: the ICICC trial. Respiratory Research 
2015;16:121. 
 
Jackson GG, Dowling HF, Spiesman IG, etal. Transmission of the common cold to volunteers 
under controlled conditions. I. The common cold as a clinical entity. Arch Intern Med 
1958;101:267-78. 
 
 

 
 
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APPENDIX 
SCREENING CRITERIA (all must be no): 
  
QUESTIONS 
YES 
NO 
Have you had sinusitis, otitis or laryngitis or any other upper respiratory 
illness in the last 2 weeks? 
 
 
Have you used topical nasal decongestant spray in the last week? 
 
 
Do you currently have nasal crusting or history of ulcers or perforation? 
 
 
Have you had severe nasal bleeding in the last 3 months? 
 
 
Are you pregnant? 
 
 
Are you allergic or sensitive to silicone? 
 
 
Do you have any underlying medical condition that would prevent your 
ability to perform treatment? 
 
 
Are you immunosuppressed or on immunosuppressant medications, such as 
prednisone or chemotherapy agents? 
 
 
 
 
 
 
 
 

 
 
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Baseline medical history and exam 
SinuSonic Study 
PI:  Meyer TA 
 Subject ID#: ______________ Subjects Initials:  _________________ 
 
 
 
DEMOGRAPHIC AND CLINICAL VARIABLES (If not previously collected): 
   
Age at enrollment (years):                                               
  
Gender:          Male        Female 
 
What is/was your profession (current/retired)?___________________________________________ 
 
Do you have significant daily contact with young children (age under 12 years)?    Yes / No 
 
Do you fly frequently, ie more than twice per month?   Yes / No 
                 
LANGUAGE, ETHNICITY, RACE, MARITAL STATUS 
Please mark one of the following categories which describes your native language: 
 
 American English 
 Other: please specify ____________________________  
 
Please mark one of the following categories which describes your ethnicity:  
 Not Hispanic or Latino  
 Hispanic or Latino  
 
Please mark one or more of the following categories which describes your race:  
 American Indian or Alaska Native  
 Asian  
 Black or African American  
 Native Hawaiian or Other Pacific Islander  
 White  
 Other  
 
 
 
 
SMOKING HISTORY 
 
 
1. Do you currently smoke tobacco products?  
 
Yes 
No  
(If No please go to question 2) 

 
 
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How many tobacco products do you use in a day? _____________________ Singles 
Packs 
Have you been tested for COVID19?                               Yes 
No 
If yes, were you positive?                                                  Yes 
No 
 
 
CURRENT MEDICATION USAGE 
 
 Nasal steroid sprays (Flonase, Nasonex, etc)                                □Yes         □No  
 Nasal antihistamine spray (Astelin, etc)                           □Yes         □No 
 Oral antihistamines (Allegra, Claritin, Benedryl, etc)                   □Yes         □No 
 Oral decongestant (Sudafed, etc)                                                   □Yes         □No 
 Mucolytic (Mucinex, etc)                                                              □Yes         □No 
 Luekotriene (Singulair, etc)                                                           □Yes         □No  
 
 
COMORBID MEDICAL CONDITIONS: Check box and provide details if present 
 
 Obstructive Sleep Apnea:   □Currently being treated      □History / No current treatment 
             
 Allergic rhinitis:________________________________________________________________ 
 Previous allergy testing (blood test or skin prick):       □Yes         □No  
 Immunotherapy shots for allergies:                              □Yes         □No       □Currently   
 Non-allergic rhinitis   □Yes         □No 
 Asthma       □Yes         □No  
 Chronic rhinosinusitis      □Yes         □No  
 Nasal polyps          □Yes         □No 
 Prior ear/sinus surgery           □Yes         □No  
 Migraine headache history:    □Resolved/past diagnosis    □Present/medicated     □Present/not medicated  
 
 
_______________________________________________________________________________ 
 
 Height (ft/in):______________________ 
 Weight (lbs):_______________________ 
 

 
 
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DAILY URI SYMPTOM SCORE 
To be completed each evening 
 
PLEASE RATE HOW BOTHERSOME YOUR SYMPTOMS 
 HAVE BEEN OVER THE PAST DAY 
 
 
Not at all 
Mild 
Moderate 
Severe 
Lost sense of smell/taste 
0 
1 
2 
3 
Sneezing 
0 
1 
2 
3 
Runny nose or thick nasal discharge 
0 
1 
2 
3 
Nasal obstruction or congestion 
0 
1 
2 
3 
Sore throat 
0 
1 
2 
3 
Cough 
0 
1 
2 
3 
Headache 
0 
1 
2 
3 
Malaise (feeling unwell or exhausted) 
0 
1 
2 
3 
Chilliness 
0 
1 
2 
3 
TOTAL SYMPTOM SCORE (TSS) 
of last 8 items 
 
 
 
 
 
Do you feel like you have a cold today?  
 
Yes/No 
 
How many times did you use Sinusonic in the last 24 hours? ___________ 
 
 
 

 
 
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Week 8 patient satisfaction/safety 
 
How much pain did you experience using device?    None     Mild      Moderate      Severe 
Bleeding after using device?  None    Mild    Moderate     Severe 
Would you use device again?     Yes      No 
Would you recommend device to others?       Yes      No