SinuSonic Study for Adults With Nasal Congestion
Phase: NA
Conditions: Nasal Congestion
Sponsor: Medical University of South Carolina

Version 1.0; Version Date: 01/12/19 
 
Page 1 of 23 
 
PROTOCOL TITLE: 
SinuSonic Study 
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. Zachary M. Soler, MD 
 
1.0   
Objectives / Specific Aims 
• 
Primary: To determine the safety and efficacy of a single SinuSonic 
intervention. 
• 
Seconday: Secondary objectives of this study is to determine: 
-the safety and efficacy of a twice daily SinuSonic intervention over 2 
weeks. 
-the safety and efficacy of a twice daily SinuSonic intervention over 4 to 6 
weeks. 
2.0 
Background 
 
Chronic sinusitis/rhinosinusitis with or without nasal polyps is a multifactorial disease 
associated with asthma, cystic fibrosis, primary ciliary dyskinesia, acetylsalicylic acid 
intolerance, and possibly allergy. It is defined as an inflammation of 1 or more paranasal 
sinuses and is considered chronic when it lasts longer than 8 weeks (Slavin 2005). It is 
almost always accompanied by concurrent airway inflammation and in many cases is 
preceded by rhinitis symptoms. 
 
Chronic sinusitis is one of the most commonly diagnosed diseases in the United States. It has 
been estimated to affect approximately 20 million Americans (Benson 1998) and up to an 
estimated 16% of the adult population annually in Europe (Huvenne 2009). There are 
currently no approved medications for treatment of chronic sinusitis.  The cardinal clinical signs 
and symptoms of chronic sinusitis include nasal blockage/congestion, facial pain or pressure, 
mucosal erythema and thickening, purulent nasal secretions, headache, and a reduction in smell 
(Fokkens 2007). Chronic disease is distinguished in part by persistence of characteristic 
symptoms for ≥8 weeks (Slavin 2005). 
 
Patients with nasal polyps tend to have a more pronounced nasal obstruction and loss of 
smell while those without nasal polyps tend to report headache and post-nasal drip more 
frequently. However, the pattern of symptoms mostly overlaps between patients with and 
without nasal polyps. 
 
Current Treatment Options: There is clear need for a better medical therapy that reduces chronic 
sinusitis symptoms, thus improving morbidity and quality of life and decreasing the need for 
surgery. Currently, there are no approved medications for the treatment of chronic sinusitis. A 

Version 1.0; Version Date: 01/12/19 
 
Page 2 of 23 
 
number of antibiotics have been approved for the treatment of acute sinusitis; however, there is 
no conclusive evidence that oral antibiotics, topical antibiotics, or topical antifungal agents are 
effective in the treatment of chronic sinusitis, and their use remains controversial, particularly 
due to concerns over emerging resistance (Ebbens 2006; Fokkens 2007; Videler 2008). As 
chronic sinusitis is characteristically an inflammatory disease, the anti-inflammatory effects of 
corticosteroids could be expected to be of benefit. There are no clinical studies published on the 
use of systemic corticosteroids for the treatment of chronic sinusitis without polyps, although 
there is evidence that systemic corticosteroids are effective at reducing the size of nasal polyps 
and improving rhinitis symptoms (Fokkens 2007; Van Zele 2010). Medical treatment with nasal 
corticosteroids (as currently available for treatment of rhinitis) is considered a first step in the 
treatment of chronic sinusitis; however, the data on sprays or drops does not suggest they are 
very effective.  
 
Patients with chronic sinusitis currently have limited medical options for treatment and no 
medication is approved for the treatment of chronic sinusitis. Standard nasal spray pumps suffer 
from a number of drawbacks and they are considered suboptimal for reliable drug delivery to 
target sites beyond the nasal valve (Aggarwal 2004). Current congestion medications are not 
always fully effective.  This study aims to test the safety and efficacy of the SinuSonic device on 
adults with moderate to severe nasal congestion.  SinuSonic is a medical device that utilizes 
sound and pressure combined with normal breathing to relieve nasal congestion. The study will 
take place over the course of 4 to 6 weeks starting with a baseline assessment.  This study will 
use patient responses to measure how effective SinuSonic devices are in treating adults with 
moderate to severe congestion in adults. 
 
3.0 
Intervention to be studied 
 
• 
Initial intervention: Subjects will use the SinuSonic device for 3 minutes in 
the clinic setting. 
• 
Secondary intervention: Subjects will use SinuSonic device twice daily for 3 
minutes in the home setting for 14 days. 
• 
Tertiary intervention: Subjects will continue to use the SinuSonic device 
twice daily for 3 minutes in the home setting for 2-4 weeks. 
3.1 
Device Instructions 
 
Instructions for use: 

Version 1.0; Version Date: 01/12/19 
 
Page 3 of 23 
 
1. Hold the SinuSonic device at a 45-degree angle 
2. Deep breathe  
3. Hold the SinuSonic to your mouth 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. Put the device over the nose using the nasal mask 
5. Breathe in and out thru the nose if possible. If nasal breathing is not possible it is ok 
to open mouth to breathe in and try and hear the “target flutter” sound when you 
breathe out  
6. You will feel a little resistance to breathe out and a vibration sensation from a 
speaker in the device 
7. Remove the device to “blow the nose” if nasal drainage occurs 
8. Return the device to the nose then breathe in and out thru the nose to try and hear 
the “target flutter” sound  
9. Time of use is 2-5 minutes of nasal breathing with the device - as tolerated 
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.  
 
4.0 
Inclusion and Exclusion Criteria/ Study Population 
The study population will consist of individuals present for care at the Otolaryngology 
clinics at the Medical University of South Carolina with nasal congestion, friends/family 
members of patients presenting for care at MUSC’s Otolaryngology clinics.   
Inclusion Criteria  
• Adults ≥18 years of age 
• Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal 
congestion score of  >5 (10 point VAS scale). 
Exclusion Criteria 
• Fixed structural cause of nasal congestion (moderate or severe septal deviation, 
moderate or severe nasal valve collapse, Grade 3-4 polyp) 
• Inability to read and understand English 
• Allergic sensitivity to silicone or any other component of device 
• History of severe nose bleeding within last 3 months 
• Anticoagulation (Aspirin ok) 
• Known pregnancy 
• Current nasal crusting or ulceration revealed on rhinoscopy 
• Inability to perform treatment due to underlying medical condition 

Version 1.0; Version Date: 01/12/19 
 
Page 4 of 23 
 
• Topical decongestant use in last week 
5.0 
Number of Subjects 
This is a pilot study.  The anticipated study population is 40 subjects. 
6.0 
Setting 
Research will be conducted at the Medical University of South Carolina.  Potential 
participants screening as well as the 2-week post treatment assessment will take place in 
the outpatient sinus clinics.  The 4-6 week assessment will be done via emailing of 
surveys. 
7.0 
Recruitment Methods 
MUSC Otolaryngologists will notify the study coordinator (SC) of potential participants 
through the Sinus Clinic.  If the patient is interested, the SC will approach them and 
explain the study in further detail and begin the informed consent process.   
8.0 
Consent Process 
Patients who are deemed eligible for this study will be approached by the Principal 
Investigator or Co-Investigator in the Sinus Clinic at the Medical University of South 
Carolina about the study.  A member of the study team will describe in full detail the 
study and the informed consent form to the potential subject.  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 be given a signed copy of 
the ICF. 
8.1  
Withdrawal 
At any point during the study, a subject may withdraw from the study. 
9.0  
Study Design / Methods 
This study is designed as a pilot study. 
Data will be collected by the ENT fellows 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. 
Safety will be monitored throughout the study based on monitoring of adverse events, 
performing nasal, measuring vital signs (i.e. blood pressure, pulse) and weight, and 
through collection of concomitant medication information.   
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 by SinuSonic at regular intervals throughout the study.  In 
addition, SinuSonic will be alerted of Adverse Events of interest via automated emails 
programmed in the EDC system. 
9.1  
Schedule of Events 

Version 1.0; Version Date: 01/12/19 
 
Page 5 of 23 
 
Phase 
Screening 
Treatment 
Week 
0 
0 
2 
4-6 
Visit 
1 
2 
3 
4 
Informed Consent 
x 
  
  
  
Inclusion/Exclusion Criteria 
x 
  
  
  
Medical History 
x 
  
  
  
Height 
x 
  
  
  
Rhinoscopy 
x 
  
x 
  
Vital Signs 
x 
  
  
  
Pregnancy Test 
x 
  
  
  
Distribution of SinuSonic 
x 
  
  
  
NOSE Questionnaire 
 x 
  
x 
x 
SNOT-22 
 x 
  
x 
x 
TNSS Questionnaire 
 x 
  
x 
x 
Global Assessment of Nasal/Sinus Problems 
 x 
x 
x 
x 
PNIF 
 x 
x 
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, quality of life (QOL) scores, and VAS scores will be summarized using 
frequencies, means, and standard deviation as appropriate.  Outcome metrics will be 
compared between baseline and 5 minutes (AIM 1), baseline and 2 weeks (AIM 2), and 
baseline and 4-6 weeks (AIM 3).  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.  If appropriate, subgroup analysis can be 
performed based on underlying disease classification (allergic rhinitis, nonallergic 
rhinitis, CRSsNP, CRSwNP). 
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, 
performing nasal exams, measuring vital signs (i.e. blood pressure, pulse) and weight, 
and through the collection of concomitant medication information. 
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.   

Version 1.0; Version Date: 01/12/19 
 
Page 6 of 23 
 
12.0 
Risks to Subjects 
There is a risk of a loss of confidentiality of your personal information as a result of 
participation in this study. 
There are risks to subjects using the SinuSonic device.  Subjects may experience a degree 
of pain due to use of the device.  This degree of pain is unknown.  There may also be risk 
of nose bleeds or crusting around the nasal cavity.   
The Rhinoscopy may activate the gag reflex.  Additionally, nasal discomfort, nose bleeds, 
spasms, and coughing may also occur. 
13.0 
Potential Benefits to Subjects or Others 
This study is for research purposes only.  There is no direct benefit to you from your 
participation in the study.  Information learned from the study may help other people in the 
future.   
14.0 
Sharing of Results with Subjects 
Information about the subjects (including your 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. 
15.0 
Payment 
For participating in this study, participants will be compensated $50 per visit for a 
maximum of $150.  This payment will be mailed to each participant within four weeks 
after completion of each visit. 
18.0 
Devices  
Dispensing and storage of SinuSonic devices will be done by the study team.  All 
SinuSonic devices will be stored on the 11th floor of Rutledge Tower in Room 1126 and 
locked in a cabinet for ambient storage.  The device will be dispensed in the Outpatient 
Sinus Clinic.  Only study participants will receive the SinuSonic for use. 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 7 of 23 
 
19.0  DATA SAFETY MONITORING AND REPORTING 
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, 
performing nasal exams, measuring vital signs (ie blood pressure, pulse) and weight, and through 
collection of concomitant medication information.   
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 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 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 MUSC IRB 
qualifications will also be reported to the MUSC 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 planned visit 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 MUSC IRB, as applicable. 
References 
Aggarwal R, Cardozo A, Homer JJ. The assessment of topical nasal drug distribution. 
Clin Otolaryngol 2004;29:201–205. 
Benson V, Marano MA. Current estimates from the national health interview survey, 
1995, National Center for Health Statistics. Vital Health Stat 1998;199:1-428. 
Crim C, Pierre L, Daley-Yates,P. A review of the pharmacology and pharmacokinetics of 
inhaled fluticasone propionate and mometasone furoate. Clin Thera 2001: 23(9):1339-
1354. 
Ebbens FA, Scadding GK, Badia L, et al. Amphotericin B nasal lavages: not a solution 
for patients with chronic rhinosinusitis. J Allergy Clin Immunol 2006;118(5):1149-1156. 
Fokkens WJ, Lund VJ, Mullol J, et al. European Position Paper on Nasal Polyps 2007. 
Rhinol 2007;45(suppl20): 1-139. 

Version 1.0; Version Date: 01/12/19 
 
Page 8 of 23 
 
Hissaria P, Smith W, Wormald PJ, et al. Short course of systemic corticosteroids in 
sinonasal polyposis: a double-blind randomized placebo-controlled trial with evaluation 
of outcome measures. J Allergy Clin Immunol 2006;118:128-133. 
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item 
Sinonasal Outcome Test. Clin Otolaryngol 2009;34(5):447-454. 
Huvenne W, van Bruaene N, Zhang N, et al. Chronic rhinosinusitis with and without 
nasal polyps: what is the difference. Curr Allergy Asthma Rep 2009; 9:213-220. 
Lildholdt T, Rundcrantz H, Bende M, Larsen K. Glucocorticoid treatment for nasal 
polyps. The use of topical budesonide, intramuscular betamethasone, and surgical 
treatment. Arch Otolaryngol Head Neck Surg 1997;123(6):595–600. 
Lildholdt T, Rundcrantz H, Lindqvist N. Efficacy of topical corticosteroid powder for 
nasal polyps: A double-blind, placebo-controlled study of budesonide. Clin Otolaryngol 
Allied Sci 1995;20(1):26–30. 
Lund VJ, Mackay IS. Staging in rhinosinusitis. Rhinol 1993;31:183-184. 
Slavin RG, Spector SL, Bernstein IL, et al; American Academy of Allergy, Asthma and 
Immunology; American College of Allergy, Asthma and Immunology; Joint Council of 
Allergy, Asthma and Immunology. The diagnosis and management of sinusitis: A 
practice parameter update. J Allergy Clin Immunol 2005;116:S13-47. 
Van Zele T, Gevaert P, Holtappels G, et al. Oral steroids and doxycycline: two different 
approaches to treat nasal polyps. J Allergy Clin Immunol, 2010;125(5):1069-1076. 
Videler WJ, van Drunen CM, Reitsma JB, Fokkens WJ. 2008. Nebulized 
bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with 
Staphylococcus aureus? A double-blind, randomized, placebocontrolled, cross-over pilot 
study. Rhinol, 2008;46:92-98. 
Vlckova I, Navrátil P, Kana R, Pavlicek P, Chrbolka P, Djupesland PG. Effective 
treatment of mild-to-moderate nasal polyposis with fluticasone delivered by a novel 
device. Rhinol 2009;47(4):419-426. 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 9 of 23 
 
Appendix 
 
Attachment 1: Patient Medical History 
SinuSonic Study 
PI:  Zachary M. Soler, MD 
 Subject ID#: ______________ Subjects Initials:  _________________ 
 
OVER THE LAST 2 WEEKS, HOW TROUBLESOME HAS THE FOLLOWING SYMPTOM BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome                             Worst 
thinkable/troublesome 
Nasal blockage/obstruction/congestion 
 
 
DEMOGRAPHIC AND CLINICAL VARIABLES (If not previously collected): 
   
Age at enrollment (years):                                               
  
Gender:          Male        Female 
 
What is/was your profession (current/retired)?___________________________________________ 
 
                 
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 

Version 1.0; Version Date: 01/12/19 
 
Page 10 of 23 
 
 
 
1. Do you currently smoke tobacco products?  
 
Yes 
No  
(If No please go to question 2) 
How many tobacco products do you use in a day? _____________________ Singles 
Packs 
2. Are you currently exposed to secondhand smoke? 
Yes 
No 
(If No please skip ahead) 
How many years have you been exposed to secondhand smoke?_______________ 
How many hours a day are you exposed to secondhand smoke?________________ 
 
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 
 
 Depression history:     □Resolved/past diagnosis    □Present/medicated     □Present/not medicated     
 Anxiety history:          □Resolved/past diagnosis    □Present/medicated     □Present/not medicated     
 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   
 Asthma       □Yes         □No  
 
 
_______________________________________________________________________________ 
 
 Height (ft/in):______________________ 
 Weight (lbs):_______________________ 
 

Version 1.0; Version Date: 01/12/19 
 
Page 11 of 23 
 
 
Attachment 2: Baseline Questionnaires 
BASELINE QUESTIONNAIRES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PATIENT QUESTIONS 
 
 
How long have you had nasal problems?         <3 months     3-6 months     6-12 months     1-3 years     >3 years 
 
 
OVER THE LAST WEEK, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome                             Worst thinkable/troublesome 
Nasal blockage/obstruction/congestion 
Nasal discharge/drainage out of the front 
or back of nose 
Pain/pressure in nose or sinuses 
Sense of smell 
OVERALL ASSESSMENT  OF NASAL 
AND SINUS PROBLEMS 
 

Version 1.0; Version Date: 01/12/19 
 
Page 12 of 23 
 
BASELINE Total Nasal Symptom Score 
 
Please answer all questions to the best of your ability. This information will assist us in 
understanding and treating symptoms. Please rate how your symptoms have been over the past 
week. 
 
Symptom 
None 
Mild: 
Symptom 
clearly present 
but easily 
tolerated 
Moderate: 
Symptom 
bothersome but 
tolerable 
Severe: Symptom 
difficult to tolerate 
– interferes with 
activities 
Nasal congestion/obstruction 
0 
1 
2 
3 
Runny nose/secretions 
0 
1 
2 
3 
Nasal itching 
0 
1 
2 
3 
Sneezing 
0 
1 
2 
3 
Sleep difficulty with nasal symptoms 
0 
1 
2 
3 
 
 
 
 
BASELINE NOSE scale 
 
Please help us to better understand the impact of nasal obstruction on your quality of life by 
completing the following survey. Thank you! 
 
Over the past ONE month, how much of a problem were the following conditions for you?  
 
 
Not a 
problem 
Very mild 
problem 
Moderate 
problem 
Fairly bad 
problem 
Severe 
problem 
Nasal congestion or stuffiness 
0 
1 
2 
3 
4 
Nasal blockage or obstruction 
0 
1 
2 
3 
4 
Trouble breathing through my nose 
0 
1 
2 
3 
4 
Trouble sleeping 
0 
1 
2 
3 
4 
Unable to get enough air through my 
nose during exercise or exertion 
0 
1 
2 
3 
4 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 13 of 23 
 
Attachment 3: Baseline SNOT-22 
 
BASELINE SNOT22 
 
 
 
 
1.  Considering how severe the problem is when 
you experience it and how frequently it 
happens, please rate each item below on how 
"bad" it is over the last 2 weeks by circling 
the number that corresponds with how you 
feel using this scale:  → 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.    Need to blow nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
2.    Sneezing 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
3.    Runny nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
4.    Cough 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
5.    Post-nasal discharge 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6.    Thick nasal discharge  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
7.    Ear fullness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
8.    Dizziness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
9.    Ear pain 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
10.  Facial pain/pressure 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
11.  Difficulty falling asleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
12.  Wake up at night 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
13.  Lack of a good night’s sleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
14.  Wake up tired 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
15.  Fatigue 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
16.  Reduced productivity 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
17.  Reduced concentration  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
18.  Frustrated/restless/irritable  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
19.  Sad  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 

Version 1.0; Version Date: 01/12/19 
 
Page 14 of 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20.  Embarrassed 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
21.  Loss of smell or taste 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
22.  Nasal obstruction 
0 
1 
2 
3 
4 
5 

Version 1.0; Version Date: 01/12/19 
 
Page 15 of 23 
 
Attachment 4: Follow Up Questionnaire 
 
FOLLOW UP 5 MINUTES 
 
 
AFTER USING SINUSONIC, HOW TROUBLESOME ARE THE FOLLOWING SYMPTOMS? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome                             Worst thinkable/troublesome 
Nasal blockage/obstruction/congestion 
Nasal discharge/drainage out of the front 
or back of nose 
Pain/pressure in nose or sinuses 
Sense of smell 
OVERALL ASSESSMENT  OF NASAL 
AND SINUS PROBLEMS 
 
 
 
Change in nasal symptoms and use of device 
 
Please rate changes in your nasal symptoms and use of device. 
 
Symptom 
None 
Mild 
Moderate 
High 
Improvement in nasal 
obstruction/stuffiness 
0 
1 
2 
3 
Improvement in nasal 
drainage/discharge 
0 
1 
2 
3 
Improvement in nasal or sinus 
pressure 
0 
1 
2 
3 
Improvement in ability to smell 
0 
1 
2 
3 
 
 
 
 
 
Pain with use of device 
None 
Mild 
Moderate 
Severe 
Comfort and ease of use 
Poor  
Low 
Moderate 
High 
Bleeding: 
Yes 
No 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 16 of 23 
 
Attachment 5: 2-Week Follow Up 
 
FOLLOW UP 2 WEEKS 
PHYSICIAN ASSESSMENT  
 
OVER THE LAST WEEK, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome                             Worst thinkable/troublesome 
Nasal blockage/obstruction/congestion 
Nasal discharge/drainage out of the front 
or back of nose 
Pain/pressure in nose or sinuses 
Sense of smell 
OVERALL ASSESSMENT  OF NASAL 
AND SINUS PROBLEMS 
 
 
 
Change in nasal symptoms and use of device 
 
Please rate changes in your nasal symptoms and use of device. 
 
Symptom 
None 
Mild 
Moderate 
High 
Improvement in nasal 
obstruction/stuffiness 
0 
1 
2 
3 
Improvement in nasal 
drainage/discharge 
0 
1 
2 
3 
Improvement in nasal or sinus 
pressure 
0 
1 
2 
3 
Improvement in ability to smell 
0 
1 
2 
3 
Use of the Device 
 
 
 
 
Pain with use of device 
None 
Mild 
Moderate 
Severe 
Comfort and ease of use 
Poor  
Low 
Moderate 
High 
Bleeding: 
Yes 
No 
 
 
Willingness to use again 
Yes 
No 
 
 
Willingness to recommend to 
friend/family 
Yes 
No 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 17 of 23 
 
 
 
Total Nasal Symptom Score 
 
Please answer all questions to the best of your ability. This information will assist us in 
understanding and treating symptoms. Please rate how your symptoms have been over the past 
week. 
 
Symptom 
None 
Mild: 
Symptom 
clearly present 
but easily 
tolerated 
Moderate: 
Symptom 
bothersome but 
tolerable 
Severe: Symptom 
difficult to tolerate 
– interferes with 
activities 
Nasal congestion/obstruction 
0 
1 
2 
3 
Runny nose/secretions 
0 
1 
2 
3 
Nasal itching 
0 
1 
2 
3 
Sneezing 
0 
1 
2 
3 
Sleep difficulty with nasal symptoms 
0 
1 
2 
3 
 
 
NOSE Scale 
 
Please help us to better understand the impact of nasal obstruction on your quality of life by 
completing the following survey. Thank you! 
 
Over the past ONE month, how much of a problem were the following conditions for you?  
 
 
Not a 
problem 
Very mild 
problem 
Moderate 
problem 
Fairly bad 
problem 
Severe 
problem 
Nasal congestion or stuffiness 
0 
1 
2 
3 
4 
Nasal blockage or obstruction 
0 
1 
2 
3 
4 
Trouble breathing through my nose 
0 
1 
2 
3 
4 
Trouble sleeping 
0 
1 
2 
3 
4 
Unable to get enough air through my 
nose during exercise or exertion 
0 
1 
2 
3 
4 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 18 of 23 
 
Attachment 6: SNOT-22 Survey 
SNOT22 Survey 
 
 
 
 
2.  Considering how severe the problem is when 
you experience it and how frequently it 
happens, please rate each item below on how 
"bad" it is by circling the number that 
corresponds with how you feel using this 
scale:  → 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.    Need to blow nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
2.    Sneezing 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
3.    Runny nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
4.    Cough 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
5.    Post-nasal discharge 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6.    Thick nasal discharge  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
7.    Ear fullness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
8.    Dizziness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
9.    Ear pain 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
10.  Facial pain/pressure 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
11.  Difficulty falling asleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
12.  Wake up at night 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
13.  Lack of a good night’s sleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
14.  Wake up tired 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
15.  Fatigue 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
16.  Reduced productivity 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
17.  Reduced concentration  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
18.  Frustrated/restless/irritable  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
19.  Sad  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 19 of 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20.  Embarrassed 
0 
1 
2 
3 
4 
5 
 
21.  Loss of smell or taste 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
22.  Nasal obstruction 
0 
1 
2 
3 
4 
5 

Version 1.0; Version Date: 01/12/19 
 
Page 20 of 23 
 
Attachment 7: 5-Week Follow Up 
 
 
FOLLOW UP 5 WEEKS 
 
 
OVER THE LAST WEEK, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome                             Worst thinkable/troublesome 
Nasal blockage/obstruction/congestion 
Nasal discharge/drainage out of the front 
or back of nose 
Pain/pressure in nose or sinuses 
Sense of smell 
OVERALL ASSESSMENT  OF NASAL 
AND SINUS PROBLEMS 
 
 
 
Change in nasal symptoms and use of device 
 
Please rate changes in your nasal symptoms and use of device. 
 
Symptom 
None 
Mild 
Moderate 
High 
Improvement in nasal 
obstruction/stuffiness 
0 
1 
2 
3 
Improvement in nasal 
drainage/discharge 
0 
1 
2 
3 
Improvement in nasal or sinus 
pressure 
0 
1 
2 
3 
Improvement in ability to smell 
0 
1 
2 
3 
Use of the Device 
 
 
 
 
Pain with use of device 
None 
Mild 
Moderate 
Severe 
Comfort and ease of use 
Poor  
Low 
Moderate 
High 
Bleeding: 
Yes 
No 
 
 
Willingness to use again 
Yes 
No 
 
 
Willingness to recommend to 
friend/family 
Yes 
No 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 21 of 23 
 
Total Nasal Symptom Score 
 
Please answer all questions to the best of your ability. This information will assist us in 
understanding and treating symptoms. Please rate how your symptoms have been over the past 
week. 
 
Symptom 
None 
Mild: 
Symptom 
clearly present 
but easily 
tolerated 
Moderate: 
Symptom 
bothersome but 
tolerable 
Severe: Symptom 
difficult to tolerate 
– interferes with 
activities 
Nasal congestion/obstruction 
0 
1 
2 
3 
Runny nose/secretions 
0 
1 
2 
3 
Nasal itching 
0 
1 
2 
3 
Sneezing 
0 
1 
2 
3 
Sleep difficulty with nasal symptoms 
0 
1 
2 
3 
 
 
NOSE Scale 
 
Please help us to better understand the impact of nasal obstruction on your quality of life by 
completing the following survey. Thank you! 
 
Over the past ONE month, how much of a problem were the following conditions for you?  
 
 
Not a 
problem 
Very mild 
problem 
 
Moderate 
problem 
Fairly bad 
problem 
Severe 
problem 
Nasal congestion or stuffiness 
0 
1 
 
2 
3 
4 
Nasal blockage or obstruction 
0 
1 
 
2 
3 
4 
Trouble breathing through my nose 
0 
1 
 
2 
3 
4 
Trouble sleeping 
0 
1 
 
2 
3 
4 
Unable to get enough air through my 
nose during exercise or exertion 
0 
1 
 
2 
3 
4 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 22 of 23 
 
Attachment 8: SNOT-22 Survey  
SNOT22 Survey 
 
 
 
 
3.  Considering how severe the problem is when 
you experience it and how frequently it 
happens, please rate each item below on how 
"bad" it is by circling the number that 
corresponds with how you feel using this 
scale:  → 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.    Need to blow nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
2.    Sneezing 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
3.    Runny nose 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
4.    Cough 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
5.    Post-nasal discharge 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6.    Thick nasal discharge  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
7.    Ear fullness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
8.    Dizziness 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
9.    Ear pain 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
10.  Facial pain/pressure 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
11.  Difficulty falling asleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
12.  Wake up at night 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
13.  Lack of a good night’s sleep 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
14.  Wake up tired 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
15.  Fatigue 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
16.  Reduced productivity 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
17.  Reduced concentration  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
18.  Frustrated/restless/irritable  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
19.  Sad  
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 

Version 1.0; Version Date: 01/12/19 
 
Page 23 of 23 
 
 
 
 
 
 
 
 
 
20.  Embarrassed 
0 
1 
2 
3 
4 
5 
 
21.  Loss of smell or taste 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
22.  Nasal obstruction 
0 
1 
2 
3 
4 
5