A New Treatment for Mechanical Nasal Obstruction

Background:

Restricted nasal breathing is a common complaint among patients presenting to Otolaryngology
clinics. 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. This condition is a daily source of discomfort that
reduces productivity and quality of life. Sufferers report shortness of breath throughout the
day, difficulty sleeping and habitual snoring, and limited stamina during sports and
exercise.

Slight dilation of the nasal passages directly counteracts nasal obstruction and reverses
symptoms in 89% of those afflicted. To this end, many patients undergo functional rhinoplasty
procedures to surgically widen the nasal passages. However, up to 20% of patients experience
unimproved or worsened symptoms postoperatively. Moreover, these surgeries are invasive,
requiring autologous grafts taken from the nose, ear, or ribs; and surgeries entail a
yearlong recovery period.

Nasal dilators such as Breathe Right strips offer a potential alternative to surgery, as
these dilators 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. 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
the Schnozzle, a small silicone stent to counteract nasal valve collapse and relieve
restricted nasal breathing. The investigators 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. The aim of this study is to evaluate the
feasibility and comfort of this device in comparison to existing commercially available
devices.

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 in standard clinical practice. This involves visualizing the nasal
cavity through nasal endoscopy and evaluating 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 participants with nasal valve collapse regarding
the various treatment options as 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 will involve a study session in which
patients are fitted with several 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 clinics with symptoms unrelated to nasal breathing to serve as a
control group.

Study design:

If a patient expresses interest in participating, the patient 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 includes the previously
validated Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument, questions
regarding the patient's current treatments, and a ranking of their preferred characteristics
of an ideal nasal dilator.

Patients will then be asked to inhale rapidly into an airflow transducer to measure peak
nasal inspiratory flow (PNIF). Following the pre-test survey participants will be fitted with
existing nasal dilator products per manufacturer recommendations (Breathe Right strips, Max
Air nose cones, Sleep Right dilator, and Nozovent dilator), and the experimental nasal
dilators designed by the research team. In this crossover design study participants will be
blinded as to which dilators are branded and which are experimental. The order of fitting
nasal dilators will be randomized.

After each fitting and use for 5 minutes to adjust to the device and confirm there is no
immediate discomfort or irritation, participants will undergo repeat PNIF testing with each
device, then will be free to go home and trial the devices. Participants will be given a
schedule specifying one device to use for at least one continuous hour per day in a
randomized order, while also being blinded as to which device participants will be using
(Schnozzle, Breathe Right, Max Air, Sleep Right, Nozovent). The devices will be numbered in a
random fashion, for participants to be able to identify which device via the assigned number
the devices are scheduled to use. Participants will similarly use the device number when
performing any device evaluation. Participants are free to wear the assigned nasal dilator at
their leisure, but must log the hours and activities performed while wearing the device (for
example, "10am-11am exercising"). Participants are not required to wear a device in public at
work or during exercise unless participants feel comfortable doing so. All devices should be
worn overnight. If there is any discomfort, irritation, skin breakdown, or epistaxis the
participant should stop wearing the device and contact the research team immediately. Each
morning, the participant will complete a survey summarizing their experience using the
assigned device. 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 participants please as long as it is consistent with proper care
and use of the device(s).

After at least five days (one day per device) the participant 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 participants will be asked to fill out a concluding survey
regarding the device participants were using. At their exit interview participants will be
asked to hand in the survey for each device participants trialed.

Inclusion Criteria:

- Patients who have presented to Otolaryngology clinics with complaints of nasal
obstruction.

- 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.

- Patients without evidence of nasal valve collapse, but are willing to participate in
the study.

Exclusion Criteria:

- History of granulomatosis with polyangiitis, extensive prior sinus or turbinate
surgery altering nasal cavity anatomy, pre-existing nasal mucosal injuries or
abnormalities