Assessing Mechanical Nasal Obstruction, a Potential New Treatment Option.
Phase: NA
Conditions: Nasal Obstruction
Sponsor: Johns Hopkins University

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 1 of 18 
 
 
COVER PAGE: protocol and statistical analysis plan 
 
Title: A New Treatment for Mechanical Nasal Obstruction 
NCT number: NCT03456115    
Document date: 7/6/20

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 2 of 18 
 
Date: _7/6/20___________________    
Principal Investigator: _Nicholas Rowan 
Application Number: _IRB00135539 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
************************************************************************************** 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research.  
Restricted nasal breathing is a common complaint among patients presenting to Otolaryngology clinics [1]. 
In fact, one in eight people experiences some degree of nasal obstruction, or regular difficulty breathing 
through the nose, which is often the result of a narrowing or collapse of the internal nasal valve [2, 3]. This 
condition is a daily source of discomfort that reduces productivity and quality of life [4]. Sufferers report 
labored breathing throughout the day, difficulty sleeping and habitual snoring, and limited stamina during 
sports and exercise [4].  
Slight dilation of the nasal passages directly counteracts nasal obstruction and reverses symptoms in 89% 
of those afflicted [5]. To this end, many patients undergo functional rhinoplasty procedures to surgically 
widen the nasal passages [6]. However, up to 20% of patients experience unimproved or worsened 
symptoms postoperatively [7]. Moreover, these surgeries are invasive, requiring autologous grafts taken 
from the nose, ear, or ribs; and they entail a yearlong recovery period [7].  
Nasal dilators such as Breathe Right strips offer a potential alternative to surgery, as they mechanically 
expand the nasal passages to effectively relieve obstruction. However, existing products are designed as 
sleep aids, and customers find them uncomfortable, difficult to use, and too visible to wear in public [8]. 
Although the mechanism for reversing nasal obstruction is straightforward, surgery is considered the only 
viable option for those who struggle to breathe during the day.  
Engineers from the Johns Hopkins Biomedical Engineering Department, partnered with clinicians from the 
Johns Hopkins Department of Otolaryngology – Head and Neck Surgery, have developed Schnozzle, a 
small silicone stent to counteract nasal valve collapse and relieve restricted nasal breathing. We 
hypothesize that this device will improve symptoms of nasal obstruction and provide patients with a viable 
alternative to visible non-invasive devices or surgical management. 
 
 
 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Primary objective:  
Determine the effectiveness of the Schnozzle nasal dilator compared to existing nasal dilator products and a 
control (unaided breathing) using objective peak nasal airflow (PNIF) measurements and the Nasal 
Obstruction Symptom Evaluation (NOSE) instrument. 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 3 of 18 
 
 
Secondary objective:  
Determine the comfort, inconspicuousness, usability, overall patient satisfaction, device compliance, sizing, 
pricing, and other patient perception of the nasal dilator products.  
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Mechanical nasal obstruction is one of the most common complaints heard by otolaryngologists 
every day [3]. In fact, over 73% of the population experiences continually elevated inspiratory resistance as 
a result of obstructed nasal airflow [4]. In patients seeking treatment, the primary causes of nasal 
obstruction are chronic inflammation due to allergies (38%) and permanent structural abnormalities (62%) 
[9]. While the inflammatory causes of nasal obstruction are generally well controlled with topical and 
systemic pharmacotherapy, the structural impedances to airflow must be treated through mechanical 
alteration of these flow-limiting segments [10]. 
The most common structural pathologies that contribute to nasal obstruction are septal deviation 
 (54%) and internal nasal valve collapse (14%), both of which increase resistance through the internal nasal 
valve.  The internal nasal valve is defined by the junction of the nasal septum, caudal border of the upper 
lateral cartilage, and head of the inferior turbinate; it contributes to two-thirds of the total nasal resistance. 
[3] As per Poiseuille’s law, resistance increases as a factor of the radius to the fourth power. As such, small 
changes to the dimensions of the internal nasal valve cause an exponential change in flow. In septal-
deviation, the septum- the bony and cartilaginous structure that divides the nasal cavity- is deflected, 
dislocated off the maxillary crest, or off-center, causing a reduction in cross-sectional area of the internal 
nasal valve. Valvular collapse occurs when the lateral nasal wall paradoxically moves medially on 
inspiration at the level of the internal valve, causing a corresponding decrease in cross-sectional area and 
increase in nasal resistance. The cause of which can be congenital – from weak upper lateral cartilage or 
lack of dilator function, develop as a result of trauma, or occur post-operatively in patients following nasal 
surgery [8].  
There are a number of over-the-counter consumer products that attempt to relieve this mechanical 
nasal obstruction in an effort to avoid surgery. One of the most popular external dilators is Breathe Right, a 
flexible strip that is adhered to the nose and stents the lateral walls of the nose outward to prevent internal 
nasal valve collapse [8]. Other existing solutions take the form of nasal cones and clips that act intra-
nasally to stent the collapsed nasal valve. While studies show that these products are mostly effective in 
increasing nasal airflow, they are typically described as uncomfortable and carry social stigma due to 
visibility during use, leaving their use for an extended period of time limited [11].  
 
During the 2016 to 2017 academic year, a team of undergraduate biomedical engineering students at 
Johns Hopkins partnered with Dr. Patrick Byrne, MD, FACS, MBA, the Director of Facial Plastic and 
Reconstructive Surgery to design and prototype a discreet silicone nasal dilator device. A survey including 
the previously validated Nasal Obstruction Symptom Evaluation (NOSE) instrument and additional 
questions regarding nasal obstruction symptoms, management options, and characteristics desirable in a 
nasal dilator device has been developed and previously approved by the Johns Hopkins IRB 
(IRB00122933). 
 
Based on this data and interviews with otolaryngologists experienced in diagnosing and treating 
nasal obstruction patients, the team developed design concepts for a mechanical nasal dilator intended to 
meet patient preferences for effectiveness, inconspicuousness, comfort, and usability. To date, the 
engineering team has conducted testing on prototypes to verify that upon compression dilators exert a 
dilation force consistent with the range that humans find effective in relieving nasal obstruction yet 
comfortable for extended periods of time. The team has assessed effectiveness of prototypes in improving 
nasal breathing using a model nose developed from de-identified patient images and informed by published 
medical research. The team also used this model with a compressed air device to confirm the stability of the 
dilator within the nose under extreme conditions, including sneezes and peak inspiratory flow.  
 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 4 of 18 
 
The next step is to collect human data to assess Schnozzle’s effectiveness in relieving nasal obstruction and 
source patient feedback to evaluate the success of these prototypes in meeting key design requirements of 
comfort, inconspicuousness, and usability. The team has conducted initial feasibility testing using the 
device and recording equipment to prepare and refine protocols for human subject testing. 
 
 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Recruitment:  
 
Participants will be recruited from patients presenting to Otolaryngology clinics with symptoms of nasal 
obstruction. The otolaryngologist in clinic will screen these patients for nasal valve collapse as they would 
in standard clinical practice. This involves visualizing the nasal cavity through nasal endoscopy and testing 
the nasal valve using Cottle maneuver (applying lateral force to the cheek to open the nasal valve) or the 
modified Cottle maneuver (using a cotton tip applicator to open the nasal valve from inside the nasal 
cavity) and evaluating for improvement in nasal obstruction symptoms. Improved nasal airflow during the 
maneuver suggests nasal valve collapse contributes to restricted nasal airflow.  
 
The clinical Otolaryngologist will counsel patients with nasal valve collapse regarding the various 
treatment options as they would in routine clinical practice (management options include to doing nothing, 
using existing nasal dilator devices, or undergoing surgery). Patients will then be invited to participate in 
the study, which would involve a study session in which they are fitted with six nasal dilator devices, 
instructed in proper care and use, and report on their function and comfort. Additional participants will be 
recruited from patients who present to Otolaryngology clinics with symptoms unrelated to nasal breathing 
to serve as a control group. Participants will also be recruited via the clinicaltrials.gov website, as well as 
using recruitment flyers and social medial posts. 
 
Study design:  
 
If a patient expresses interest in participating they will be introduced to a member of the research team to 
discuss the study and complete informed consent. All participation is voluntary and participants are able to 
withdraw from the study at any point. The study participant will be asked to complete a questionnaire, 
which was adapted from the previously approved survey (IRB00122933), which includes the NOSE 
instrument, questions regarding the patient’s current treatments, and a ranking of their preferred 
characteristics of an ideal nasal dilator (see Appendix A). 
 
Patients will then be asked to inhale rapidly into an airflow transducer to measure baseline peak nasal 
inspiratory flow (PNIF). Following the pre-test survey participants will be fitted serially with five 
commercially available nasal dilator products per manufacturer recommendations (Breathe Right strips, 
Max Air nose cones, Sleep Right dilator, Mute dilator, and Nozovent dilator), and one experimental nasal 
dilator designed by the research team (“Schnozzle”). In this crossover design study participants will be 
blinded as to which dilators are branded and which are experimental, and the order of fitting nasal dilators 
will be randomized. Each subject will undergo PNIF testing for all six devices. 
 
After each fitting and use for five minutes to adjust to the device and confirm there is no immediate 
discomfort or irritation, participants will undergo repeat PNIF testing with each device and then will be free 
to go home and trial the devices on their own. Participants will be given a schedule specifying one device 
to trial for at least one continuous hour per day. This schedule will specify devices in a randomized order, 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 5 of 18 
 
and participants will continue to be blinded as to which device they will be using on a particular day 
(Schnozzle, Breathe Right, Max Air, Sleep Right, Mute, and Nozovent). The devices will be numbered in a 
random fashion, for participants to be able to identify which device via the assigned number they are 
scheduled to use on that day. They will similarly use the device number when performing any device 
evaluation.  
 
Participants are free to wear the assigned nasal dilator at their leisure beyond one hour, but must log the 
hours and activities performed while wearing the device (for example, “10am-11am exercising”). Patients 
are not required to wear a device in public at work or during exercise unless they feel comfortable doing so. 
All devices should be worn overnight. When the schnozzle is utilized at night, a modified version will be 
used where each portion inserted into the nares will be connected by an external bridge. This is to prevent 
posterior displacement of the device during sleep. Each morning, the participant will complete a survey 
summarizing their experience using the assigned device (Appendix B). If there is any discomfort, irritation, 
skin breakdown, or epistaxis the participant should stop wearing the device and contract the research team 
immediately.  
 
Over the course of the first six days since the initial clinic visit, the participant will trial and log their use of 
each of the six nasal dilators. After at least six days (one day per device) participants will return to the 
office for an exit interview with the study team in regards to their subjective experience with each device. 
At the end of each trial day they will be asked to fill out a concluding survey (see appendix C). At their exit 
interview they will be asked to submit both appendix B and C for each device they trialed.  
 
Before returning to the clinic for the conclusion of the study, participants may have several days without an 
assigned device. Participants are free to stop wearing all devices or use any device as they please as long as 
it is consistent with proper care and use of the device(s). 
 
b. Study duration and number of study visits required of research participants. 
This study requires two office visits – one to begin the study with baseline PNIF measurements, device 
fitting, PNIF with each device in place, and a perception survey. This will be followed up with a wrap up 
visit end the study with a concluding survey. Each patient will participate in the study for at least six days 
to trial each device, and the entire duration depends on an individual patients’ ability to return to the clinic, 
no more than two weeks. 
 
Participants will be free to stop participating at any point during the study. Participants will have the option 
to be included in a list of individuals who would be interested and willing in participating in additional 
study sessions.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
Patients will be blinded to the names of the devices tested to limit bias when they complete the surveys. 
They will also be blinded as to which device was designed by members of the research team.  
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
The standard of care is to do nothing, use existing nasal dilator devices, or surgery. This one session 
comparison study of nasal dilators does not prevent patients from proceeding with the standard of care after 
the study session, and will familiarize them more thoroughly with available treatment options. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
Participants will serially wear the prototype Schnozzle device and marketed nasal dilators, all of which are 
treatments. We will get a baseline NOSE and PNIF score from participants without any assistive devices in 
place, which serves as the placebo/ non-treatment arm of the study. Following the study session participants 
can continue to use currently marketed nasal dilators or proceed with planning surgery. 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 6 of 18 
 
 
f. Definition of treatment failure or participant removal criteria. 
Participants will be removed from the study if they experience substantial discomfort with the study 
devices, or if they experience any adverse events, such as epistaxis, or skin breakdown or if they would like 
to discontinue testing for any reason. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
At the end of the study session participants will be able to continue using any of the marketed nasal dilator 
products currently on the market, and this study will not influence their ability to proceed with scheduling 
surgery if indicated and desired. They will not be able to continue using the Schnozzle nasal dilators at this 
time as it is still in early stage development and not widely produced or available.  
 
5. 
Inclusion/Exclusion Criteria 
Subjects will be recruited from patients who have presented to Otolaryngology clinics with complaints of 
nasal obstruction. Specifically, patients who have been found to have nasal valve collapse by an 
Otolaryngologist based on performance of the Cottle maneuver will be invited to participate in the study.  
Additionally, participants will be evaluated for inclusion in the same manner if they were recruited 
utilizing flyers, social media, or discovered our study via the clinicaltrials.gov website. They will be 
excluded if after examination they are determined by their Otolaryngologist to be unsuitable or unsafe for 
an internal nasal dilator (e.g. history of granulomatosis with polyangiitis, extensive prior sinus or turbinate 
surgery altering nasal cavity anatomy, pre-existing mucosal injuries or abnormalities). Included 
participants will then be asked to complete the survey, NOSE questionnaire, and testing session either at 
the same visit or on another visit depending on patient and tester availability. Additionally we will include 
a control arm whom do not have evidence of nasal valve collapse, but are willing to participate in the 
study. Members of the control arm will also be excluded if they are deemed unsuitable based on nasal 
anatomy and/or the above exclusion criteria listed above.  
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
The control devices (Breathe Right strips, Sleep Right dilator, Mute dilator, Nozovent dilator, and Max Air 
nose cones) were selected from several other nasal obstruction products available on the market based on 
discussions with patients and opinion leaders in nasal airway obstruction due to their popularity and 
reported effectiveness. These are all legally marketed in the United States as Class I 510(k) exempt medical 
devices available over-the-counter. 
 
The Schnozzle was developed as a non-invasive, discreet alternative to the current products available for 
nasal airway obstruction. Schnozzle is still in prototype form, and this testing will influence final design 
updates to improve the dilator before full-scale manufacturing and marketing. For this testing, Schnozzle 
prototypes will be produced using an FDA approved silicone. 
 
Schnozzle is a Class I device not requiring FDA approval prior to use in humans. It fits into the existing 
internal nasal dilator classification as defined by Code of Federal Regulations (CFR) Title 21, Part 874 - 
Ear, Nose, Throat Devices, Subpart D - prosthetic devices, section 874.3900. According to this definition, a 
nasal dilator “provides relief from temporary causes of breathing difficulties resulting from structural 
abnormalities” through a mechanism that “decreases airway resistance and increases nasal airflow”. More 
specifically, the Schnozzle device fits into the internal nasal dilator subcategory. As stated in the FDA’s 
ruling, “the internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts 
by pushing the nostrils open or by gently pressing on the columella”. The Schnozzle nasal dilator fits this 
definition, being a prosthetic device placed inside the nostril with the purpose of increasing nasal airflow. 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 7 of 18 
 
As confirmed by Greenleaf Health, a regulatory consulting firm, Schnozzle can be considered Class I 
device exempt from 510(K) premarket notification. 
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed.  N/A 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered. N/A 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 8 of 18 
 
Date: __7/6/20_________________________________    
Principal Investigator: __Patrick Byrne____________ 
Application Number: ___IRB00135539_________ 
7. 
Study Statistics 
a. Primary outcome variable. 
Peak Nasal Inspiratory Flow (PNIF) and Nasal Obstruction Symptom Examination (NOSE) 
score for each individual before the trial and while using each tested nasal dilator. 
 
b. Secondary outcome variables. 
Comfort, appearance, ease of use, and general favorability of each device. 
 
c. Statistical plan including sample size justification and interim data analysis. 
The purpose of this pilot study is to understand patient needs and preferences regarding nasal 
dilators, and to use this data to refine the design before potentially marketing the product. In this 
pilot study we plan to test 70 individuals with nasal valve collapse. Previous studies have 
demonstrated an ability to detect a statistically significant difference in PNIF with a power of 
80% and an alpha of 0.05 with a sample size of 30 patients with nasal valve collapse. We aim to 
recruit 70 individuals, 35 patients with nasal valve collapse, 35 patients without nasal valve 
collapse with expected attrition of 5 patients in each cohort.[12]  If we proceed to pursue 
statistical evaluation of the data we will use ANOVA with a p < 0.05 predetermined as 
significant. 
 
d. Early stopping rules. 
After 5 and 10 participants complete testing we will evaluate the data to look for themes and 
determine if further testing is likely to yield additional information. If a large percentage of 
patients are unable to complete the study due to complaints with device comfort or due to 
previously defined adverse outcomes we will halt the study.   
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
Application and wearing of any of the experimental or existing nasal dilators could conceivably 
lead to: 
1. Discomfort, including moderate temporary pain, or irritation, including tickling that may 
cause sneezing. Discomfort associated with wearing the devices is expected to be uncommon, 
minor, and self-limited. Participants have the option to refuse or remove any or all of the nasal 
dilator system at any point. 
2. Epistaxis (nose bleeding), is unlikely given that patient with abnormal nasal mucosa are not 
included in the study. Participants will be trained and assisted by study personnel to a-
traumatically apply and remove the nasal dilator devices. Should a participant experience 
epistaxis they will be managed according to the standard of care, which would involve 
application of manual pressure to the cartilaginous portion of the nose for 20 minutes. Should 
bleeding be severe or persistent they will be seen by an Otolaryngologist for further 
management and treatment. 
3. Migration of nasal dilator device is highly unlikely given the pre-clinical testing of nasal 
dilators in a nose model under extreme conditions of high airflow that could be associated with 
sneezing and peak inspiratory breathing. Additionally, the normal nasal anatomy, namely the 
inferior nasal turbinates, limit the open space in the nose and should prevent migration of nasal 
dilators. Individuals with markedly abnormal inferior turbinates are excluded from this study. 
4. Nasal dilators may be ineffective at improving nasal airflow during the study. These subjects 
will not be excluded but may leave the study. 
 
b. Steps taken to minimize the risks. 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 9 of 18 
 
Included in each risk above. 
 
c. Plan for reporting unanticipated problems or study deviations. 
Any unanticipated problems, adverse events, or study deviations will be immediately discussed 
with the principal investigator (PI) and reported to the IRB if deemed appropriate by the PI. This 
will be done using RF3 and RF4 as needed. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
All collected data will be stored on an encrypted drive password protected as per protocol. 
Patient data will be de-identified and not have a name or date of birth associated with it.  
 
e. Financial risks to the participants. 
Participants’ only financial risk is the opportunity cost associated with their time spent in office 
at the beginning and end of the trial. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
By participating in this study, individuals with nasal valve collapse will have an opportunity 
to trial several existing nasal dilators. In typical clinical practice patients are given 
recommendations for several types of nasal dilators but are not fitted and trained in 
appropriate use. Participants may notice a marked improvement in their ability to breathe 
while wearing the devices and an enhancement in quality of life. 
 
Schnozzle has the potential to improve of the quality of life for the millions of nasal 
obstruction sufferers who currently forgo treatment. Faced with the choice between inaction 
and the appointments, extensive recovery period, and uncertain outcome inherent with 
surgery, the majority of individuals—especially those with minor to moderate obstruction—
elect to live with their symptoms, which present a constant bother, source of embarrassment, 
and long-term health risk.  
 
While existing nasal dilators are effective in temporarily relieving their symptoms, sufferers 
agree that existing products are not an option for use in their daily lives. However, these 
same individuals insist that a comfortable and discreet device would present a preferred 
solution to surgery to aid their breathing during the day. This trial will provide the clinical 
evidence necessary to evaluate and inform redesigns of existing prototypes to aid in the 
development of a finalized product ready for the market. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
 
Participants will not be paid, but they will be given the option to keep any of the marketed 
nasal dilators they trialed (Breathe Right, Max Air, Sleep Right, Mute, Nozovent). 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
The cost of the nasal dilators for participants will be borne by the research team including 
the principal investigator. 
 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 10 of 18 
 
 
References: 
[1] Jenson M, Malm L. Definition, prevalence and development of nasal obstruction. Allergy.  
1997; 52 (SUPP/40): 3-6 
[2] Rhinomed. Roadshow Presentation. N.p., Mar. 2016. Web.  
<http://www.rhinomed.global/wp-content/uploads/2016/03/Roadshow-Presentation.pdf>. 
[3] Bloching MB. Disorders of the nasal valve area. GMS Curr Top Otorhinolaryngol Head Neck  
Surg. 2007;6:7. 
[4] Miman MC, Deliktas H, Ozturan O, et al. Internal nasal valve: revisited with objective facts.  
Otolaryngol Head Neck Surg. 2006;134:41-47.  
[5] Camacho, M., Zaghi, S., Certal, V. et al., 2016,  “Predictors of Nasal Obstruction:  
Quantification and Assessment Using Multiple Grading Scales,” Plastic Surgery International, vol. 
2016, Article ID 6945297, 9 pages: doi:10.1155/2016/6945297 
[6] Khosh MM, Honrado C, Pearlman SJ. Nasal Valve Reconstruction. Arch Facial Plast Surg.  
2004. 6:167-171.  
[7] Schlosser, R.J. and Park, S. S., 1999, "Surgery for  
the Dysfunctional Nasal Valve." Archives of Facial Plastic Surgery 1, no. 2: 105. 
doi:10.1001/archfaci.1.2.105. 
http://jamanetwork.com/journals/jamafacialplasticsurgery/fullarticle/479692 
 [8] Kiyohara, N., 2016, "A Comparison of Over-the-Counter Mechanical Nasal Dilators." JAMA  
Facial Plastic Surgery 18, no. 5: 385. doi:10.1001/jamafacial.2016.0291. 
[9] Picavet VA, Grietens J, Jorissen M, Hellings PW. Rhinoplasty from a rhinologist's perspective: need for 
recognition of associated sinonasal conditions. Am J Rhinol Allergy. 2012; 26: 493–496. 
[10] Samaha M, Rassouli A. Spreader graft placement in endonasal rhinoplasty: technique and review of 
100 cases. Plast Surg (Oakv). 2015 Winter. 23 (4):252-4. 
 [11] Kimbell JS, Frank-Ito DO. Mechanical Nasal Dilators for the Management of Nasal Obstruction. 
JAMA Facial Plast Surg. 2016;18(5):389-390. doi:10.1001/jamafacial.2016.0656. 
[12] Raudenbush, B, Stenting the nasal airway for maximizing inspiratory airflow: Internal Max-Air Nose 
Cones versus external Breathe Right strip. Am J Rhinol Allergy 25,249-51, 2011.   

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 11 of 18 
 
COVER PAGE: Informed Consent 7/6/20 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 12 of 18 
 
 
 
 
 
 
 
RESEARCH PARTICIPANT INFORMED CONSENT AND 
PRIVACY AUTHORIZATION FORM 
 
Protocol Title:  
Assessing Mechanical Nasal Obstruction Experience and A 
Potential New Treatment Option 
 
 
Application No.:  
IRB00135539 
 
Principal Investigator:  Nicholas Rowan, MD 
601 N. Caroline St. 6th Floor 
Baltimore, MD 21287 Main: (410) 614-6243 
 
 
1. 
What you should know about this study: 
• You are being asked to join a research study. This consent form explains the research study and 
your part in it. Please read it carefully and take as much time as you need. Ask your study doctor 
or the study team to explain any words or information that you do not understand. 
• You are a volunteer.  If you join the study, you can change your mind later.  There will be no 
penalty or loss of benefits if you decide to quit the study.   
• During the study, we will tell you if we learn any new information that might affect whether you 
wish to continue to participate. 
• If we think your participation in this study may affect your clinical care, information about your 
study participation will be included in your medical record, which is used throughout Johns 
Hopkins.   Doctors outside of Johns Hopkins may not have access to this information.  You can 
ask the research team to send this information to any of your doctors. 
• When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, 
The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General 
Hospital, Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital 
and All Children’s Hospital.  
• A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time.  
• If you would like to review the information for this study, or a summary of the results, ask the 
study team doctor for the ClinicalTrials.gov study registration number. 
 
2. 
Why is this research being done? 
This research is being done to determine whether nasal airway obstruction can be improved with 
mechanical nasal dilators.  
 
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
 
 
 
 
 
Patient I.D. plate 
 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 13 of 18 
 
Currently nasal airway obstruction can be managed with no intervention, the use of over the counter 
mechanical nasal dilators, or with surgery. We want to determine if use of these over the counter 
devices significantly improves patient symptoms. We also want to determine if different nasal 
dilator devices improve symptoms of airway obstruction to different extents.  
 
Devices we will be examining include Breathe Right strips, Sleep Right dilator, Mute dilator, 
Nozovent dilator, and Max Air nose cones. These listed devices are commercially available over-
the-counter mechanical nasal dilators. Breathe Right strips, Nozovent, and Max Air are approved by 
the Food and Drug Administration (FDA) for relief from temporary causes of breathing difficulties 
resulting from structural abnormalities. Mute and Sleep Right are registered with the FDA and fall 
under the new category that exempts nasal dilators from the FDA 510(k) approval process due to 
their low-risk characteristics. 
 
Additionally, we also want to determine if our team’s investigational design of an internal nasal 
dilator can also improve symptoms of nasal airway obstruction and if it can do so to a greater extent 
than the previously listed commercially available devices. As with the Mute and Sleep Right 
dilators, our team’s investigational device is exempt from FDA approval as it fulfills the definition 
of a nasal dilator and is exempt from the approval process. 
 
People both with and without mechanical nasal obstruction as diagnosed by an Otolaryngologist 
(Ear, Nose, & Throat doctor) may join.  
 
How many people will be in this study? 
We expect a total of 70 people to be enrolled in this study.  
 
3. 
What will happen if you join this study? 
 
If you agree to be in this study, we will ask you to do the following things: 
 
In Office Portion  
• You will complete a baseline survey in regards to your symptoms of nasal obstruction, and 
you will then undergo testing of your nasal airway resistance. This testing is completed by 
breathing in against an airflow measuring tool attached to a small mask worn over your 
mouth and nose. This testing will take no longer than 5-10 minutes.  
• After baseline testing you will then be fit with the appropriately sized nasal dilator by our 
team. You will be fit with 6 total devices: 5 commercially available devices and 1 
investigational device.  
• You will be blinded to the name of each device and as to which device is our investigational 
device. This means that you will not know which device you are being fit with or using. We 
do this so that your evaluation of each device is not biased in any way.  
• After we have fit you with the correctly sized device, we will repeat testing of your nasal 
airway resistance with each device in place. 
• We estimate the fitting period and repeat nasal airway resistance tests with the device in 
place will take about 20 minutes. Therefore the total length of your clinic visit would be 
increased by  about 30 minutes total.  
 
At Home Portion  
• You will then be instructed to take the 6 nasal dilator devices home and begin using each 
device as instructed. Specifically, you will be assigned to use each device in a randomized 
order (like drawing numbers out of a hat that correspond to the order you should use a 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 14 of 18 
 
device in) and asked to wear each device for at least one hour continuously while you are 
awake.  
• You will be asked to document what activities you were doing while wearing the device and 
for how long. 
• You will then be asked to wear the same device overnight. Following your overnight trial 
with the device you will be asked to fill out a survey about your experience with that device. 
We will then ask you to do the same for the 5 other devices over the 5 following days. 
• As there are 6 devices this at home portion of the study will take 6 days: 1 daytime and 1 
overnight trial period for each device.  
 
In Office Debriefing 
• After evaluating all the devices you will be asked to come back in for an additional office 
visit where we will ask you questions about your experience with each device and you will 
be asked to fill out a survey ranking the device from your most favorite to least favorite. 
You will also be asked to hand in your surveys and other documentation you completed at 
home for each device at this time.  
• You will be able to keep any of the commercially available devices if you wish to continue 
to use them. You will not be able to keep or continue using our investigational device.  
 
How long will you be in the study? 
The entire study encompasses 2 in office visits and a 6 day at home trial period.  
 
4. 
What are the risks or discomforts of the study? 
 
Risks of joining the study 
• There are minimal risks of joining the study as using these mechanical nasal dilator devices 
is currently an accepted standard of care for mechanical nasal obstruction. Additionally your 
participation will not prevent you from pursuing the other potential management option of 
surgery at a later date.  
 
Risks with device use 
• The risks with device use are minimal and all unlikely. They include the following: 
o Skin irritation or breakdown around where the device is inserted or placed on the 
nose 
o Nose bleeding.  
o Device becoming lodged within the nasal cavity requiring removal by your doctor. 
 
If you have any of the above outcomes you will be asked to immediately stop using the 
device(s) and contact Drs. Rowan, Papel and/or Kontis for in-office evaluation. Management 
of each of these potential risks will be on a case-by-case basis based on that examination. 
Interventions required or needed may range from nothing and just discontinuation from the 
study, to application of topical ointment (in the case of skin breakdown), to, in the very rare 
and unexpected case of nose bleeds that do not stop on their own, use of topical thrombotic 
agents (agents that make your blood clot).  
 
 
Other Risks: 
You may get tired or bored when we are asking you questions or you are completing questionnaires. 
You do not have to answer any question you do not want to answer. You may also get tired of using 
the different device, and/or of documenting your use and experience with each one. If at any point 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 15 of 18 
 
you feel this way you may stop documenting or using the devices and leave the trial without any 
consequence.  
 
 
Risks to Confidentiality Loss: 
There is the risk that information about you may become known to people outside this study. We 
will not be collecting any personal information from you other than the measurements of your nasal 
airway resistance. As such, there is very minimal risk of a loss of confidentiality of your personal 
information.  
 
5. 
Are there benefits to being in the study? 
There is no direct benefit to you from being in the study. If you take part in this study, you may help 
others in the future. We will be able to understand if mechanical nasal dilators are a reasonable 
alternative to surgery for patients with nasal airway obstruction.  
 
6. 
What are your options if you do not want to be in the study? 
If you decide not to join this study, other options are available.  You do not have to join this study to 
get treatment.  Other treatments include surgery to correct nasal airway obstruction or no 
intervention at all.  
 
You do not have to join this study.  If you do not join, your care at Johns Hopkins will not be 
affected. 
 
7. 
Will it cost you anything to be in this study?   
 
You will receive a separate Insurance and Research Participant Financial Responsibility 
Information Sheet (Sheet).  
 
This Sheet will give you the following information: 
 
• The procedures, tests, drugs or devices that are part of this research and that will be paid for 
by the study (no cost to you).   
 
• The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  
If you have health insurance, you will be responsible for any co-pays or deductibles not 
covered by your insurance.  
 
8. 
Will you be paid if you join this study? 
 
No. However,  you will be able to keep and use any of the commercially available nasal dilators.  
 
9. 
Can you leave the study early? 
• You can agree to be in the study now and change your mind later. 
• If you wish to stop, please tell us right away. 
• Leaving this study early will not stop you from getting regular medical care.  
 
If you leave the study early, Johns Hopkins may use or give out your health information that it has 
already collected if the information is needed for this study or any follow-up activities 
 
10. 
Why might we take you out of the study early?  

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 16 of 18 
 
You may be taken out of the study if: 
• Staying in the study would be harmful. 
• You fail to follow instructions. 
• The study is cancelled. 
• There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information 
that it has already collected if the information is needed for this study or any follow-up activities. 
 
11. 
How will your privacy be protected?  
We have rules to protect information about you.  Federal and state laws and the federal medical 
Privacy Rule also protect your privacy.  By signing this form you provide your permission, called 
your “authorization,” for the use and disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things 
learned from the procedures described in this consent form.  They may also collect other 
information including your name, address, date of birth, and information from your medical records 
(which may include information about HIV status, drug, alcohol or STD treatment, genetic test 
results, or mental health treatment). 
 
The research team will know your identity and that you are in the research study.  Other people at 
Johns Hopkins, particularly your doctors, may also see or give out your information. We make this 
information available to your doctors for your safety.    
 
People outside of Johns Hopkins may need to see or receive your information for this study.  
Examples include government agencies (such as the Food and Drug Administration), safety 
monitors, other sites in the study and companies that sponsor the study.  
 
If you are in a cancer study that receives federal funding, the National Cancer Institute (NCI) now 
requires that we report identifiable information (such as, zip code) about your participation.  You 
may contact the NCI if you have questions about how this information is used.  
 
We cannot do this study without your authorization to use and give out your information.  You do 
not have to give us this authorization.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of 
Privacy Practices; however, people outside Johns Hopkins who receive your information may not 
be covered by this promise or by the federal Privacy Rule.  We try to make sure that everyone who 
needs to see your information keeps it confidential – but we cannot guarantee that your information 
will not be re-disclosed. 
 
The use and disclosure of your information has no time limit. You may revoke (cancel) your 
permission to use and disclose your information at any time by notifying the Principal Investigator 
of this study by phone or in writing.  If you contact the Principal Investigator by phone, you must 
follow-up with a written request that includes the study number and your contact information.  The 
Principal Investigator’s name, address, phone and fax information are on page one of this consent 
form.  
 
If you do cancel your authorization to use and disclose your information, your part in this study will 
end and no further information about you will be collected. Your revocation (cancellation) would 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 17 of 18 
 
not affect information already collected in the study, or information we disclosed before you wrote 
to the Principal Investigator to cancel your authorization. 
 
12. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from 
being in the study.  However, medical care at Johns Hopkins is open to you as it is to all sick or 
injured people.   
 
The costs for any treatment or hospital care you receive as the result of a study-related injury that 
are not covered by a health insurer will be billed to you. 
 
By signing this form you will not give up any rights you have to seek compensation for injury.  
 
13. 
What other things should you know about this research study? 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
• Doctors 
• Nurses 
• Ethicists 
• Non-scientists 
• and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and welfare of the people taking 
part in those studies.  You may contact the IRB if you have questions about your rights as a 
participant or if you think you have not been treated fairly.  The IRB office number is 410-955-
3008. You may also call this number for other questions, concerns or complaints about the 
research. 
 
When the Johns Hopkins School of Medicine Institutional Review Board (IRB) reviews a study 
at another site, that site (institution) is solely responsible for the safe conduct of the study and 
for following the protocol approved by the Johns Hopkins IRB.   
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Nicholas Rowan at (410)614-6243. If you wish, you may 
contact the principal investigator by letter.  The address is on page one of this consent form. If 
you cannot reach the principal investigator or wish to talk to someone else, call the IRB office at 
410-955-3008.   
 
c. What should you do if you are injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Dr. Nicholas Rowan at (410) 614-
6243during regular office hours.  
 
d. What happens to Data that are collected in the study?  
Johns Hopkins and our research partners work to understand and cure diseases. The data you 
provide are important to this effort. 
 
If you join this study, you should understand that you will not own your data, and should 
researchers use them to create a new product or idea, you will not benefit financially. 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 18 of 18 
 
 
 
14. 
What does your signature on this consent form mean?  
Your signature on this form means that: You understand the information given to you in this form, you 
accept the provisions in the form and you agree to join the study. You will not give up any legal rights by 
signing this consent form.  
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
___________________________________________________________________________________________________________________
_____ 
Signature of Participant                                                                           (Print Name)                                                 
 
Date/Time  
 
 
___________________________________________________________________________________________________________________
_____ 
Signature of Person Obtaining Consent                                                  (Print Name)                                               
 
Date/Time 
 
 
___________________________________________________________________________________________________________________
_____ 
Signature of Witness to Consent Procedures                                         (Print Name) 
 
Date/Time
 
 
(optional unless IRB or Sponsor required) 
 
 
I have received the separate Insurance and Research Participant Financial Responsibility Information Sheet.   
 
___________________________________________________________________________________________________________________
_____ 
Signature of Participant, LAR or Parent/Guardian                               (Print Name)                                                        
 
 Date/Time 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY MUST BE 
GIVEN TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT 
USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR 
WILL BE CREATED).  
 
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT OF 
RESEARCH PARTICIPANTS.