A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring
Phase: NA
Conditions: Obstructive Sleep Apnea, Snoring
Sponsor: Stanford University

A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring 
NCT02928770 
October 27, 2016 
Clete A. Kushida, MD, PhD, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The purpose of the research study is to test a new approach for treating patients with 
snoring and obstructive sleep apnea (OSA). A special device (NAS-nasal stent) appears 
to be a useful alternative or additive treatment for patients with OSA. 
b. 
Objectives 
We hope to learn through this study if this device provides a better alternative treatment 
for obsturctive sleep apnea and snoring. 
c. 
Rationale for Research in Humans 
2. 
STUDY PROCEDURES 
a. 
Procedures 
This research study is seeking to enroll up to 30 participants with OSA and snoring. The 
enrollment will be at Stanford Sleep Medicine Center. The NAS (straight type) supports 
the soft palate from "collapsing" by supporting it physically, as well as securing the 
passage of airflow both inside and outside of the tube. Participants in the proposed study 
will undergo any or all of the following procedures. 
 
After the consent process (30 min), each participant will be asked to complete either 
paper questionnaires which inquires about his or her demographic information and 
medical history (Sleep Disorders Questionnaire, 30 min) and level of daytime sleepiness 
in various situations (Epworth Sleepiness Scale, 5 min) or an electronic questionnaire 
(Alliance Sleep Questionnaire, 20 min). 
 
Each participant will be asked to submit to an initial evaluation (60 min), which consists 
of a discussion of the participant's sleep habits and problems, medical history of 
participant and family, review of systems, medications, education, employment, and 
personal habits. A general physical examination, including but not limited to examination 
of the mouth and throat, and measurements of his or her weight and height; 
circumference of neck, waist, and hip; pulse and respiration rate; and blood pressure. 
 
The participants will undergo two sleep studies: one sleep study at our center prior to 
using the NAS device (Baseline) and another after 7 days of use of the device at their 

October 27, 2016 
 
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homes (Treatment). The participants will wear the NAS device during the second sleep 
study. 
 
The sleep study will be conducted in routine fashion, with recording electrodes and 
equipment attached to the participant to enable monitoring of the electroencephalogram 
(EEG, C3-A2 and C4- A1, O2-A1 and O1-A2), electro-oculogram (EOG, ROC-A1, 
LOC-A2), chin and anterior tibialis electromyograms (EMG), heart rate by two-lead 
electrocardiogram (EKG), snoring intensity (anterior neck microphone), nasal pressure 
(nasal cannula), oral airflow(thermocouple), thoracic and abdominal movement 
(inductance plethysmography bands), and oxygen saturation (pulse oximetry). The 
duration of the application of all of these electrodes and recording devices to the 
participant is approximately 1.5 hours. The polysomnogram will be scheduled to allow at 
least 7 hours but no more than 9 hours of time in bed for the participant during the night. 
 
The participants will be provided the following instructions for handling the NAS device: 
-Before handling the NAS, wash hands and nails thoroughly with 
soap. Make sure to thoroughly rinse off the soap as well. 
-Check NAS package carefully for breakage on the package. In case 
of breakage, do not use and contact the clinical research staff. 
-Check right or left nostril for intended insertion 
-Open NAS package, and take out NAS device. 
-Insert the tube to the appropriate side and slide NAS device 
slowly into the nasal airway. 
-Clip the stopper on to the nasal septum / bridge to secure the 
device. 
-Open the mouth in front of a mirror; check that there is the tip 
of the NAS device showing 3mm from the soft palate. 
-Go to sleep with the NAS applied. 
-Remove the NAS through nose and dispose once awake. 
-Limit use of this device to a maximum of 10 hours. Always dispose after use, and do not 
re-use. Use within six months. 
 
Participants will have the option to to receive the nasal device after the second sleep 
study. The patient will be allowed to receive complimentary nasal stents until the time the 
device becomes commercially available. During this time, each participant will be asked 
to complete and submit the Epworth Sleepiness Scale every three months. 
 
-Close out visit 
 
After completion of the first sleep study (baseline) and second sleep study (treatment), 
subject will be asked to come back for a follow-up visit to discuss the results of his/her 
sleep studies with the study doctor, Dr. Kushida. During this visit, the study doctor or 
research coordinator will ask the subject to place the nasal stent into his/her nostril, and 
the PI or research coordinator will then take pictures of the back of the subject's mouth, 
where the nasal stent should be resting. Subject's face will not be included in the photos. 
If after meeting with the study doctor and the subject would like to try the nasal stent in a 
different size, the subject may have a repeat treatment PSG. 

October 27, 2016 
 
Page 3 of 10 
b. 
Procedure Risks 
The above procedures are in clinical use at our center. We are taking all necessary 
precautions for any risk that may occur in this clinical study. 
c. 
Use of Deception in the Study 
Not Applicable 
d. 
Use of Audio and Video Recordings 
Participants will be videotaped during the sleep study as per our usual sleep clinic 
protocol. The videotapes will be kept for 7 years and then destroyed. 
e. 
Alternative Procedures or Courses of Treatment 
Alternative treatments for obstructive sleep apnea will be discussed with the participant, 
including continuous positive airway pressure (CPAP), upper airway surgery, and oral 
appliance therapy. There are risks/benefits to all these alternative treatments that will be 
discussed with the participants; these are standard of care treatments. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
Yes 
g. 
Study Endpoint(s) 
The study will end after 30 participants are completed. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Nasal airway stents have been tried in sample populations with mixed results. The 
sponsor of the proposed study has developed several versions of their device, of which 
the device for the proposed study appears to be the most promising as tested in a few 
subjects by the sponsor in an internal study. 
b. 
Findings from Past Animal Experiments 
Not Applicable 
4. 
RADIOISOTOPES OR RADIATION MACHINES 
a. 
Standard of Care (SOC) Procedures 
Identify Week/Month of Study 
Name of Exam 
Identify if SOC or Research 
NA 
NA 
NA 
b. 
Radioisotopes 
i. 
Radionuclide(s) and chemical form(s) 
NA 

October 27, 2016 
 
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ii. 
Total number of times the radioisotope and activity will be administered (mCi) and 
the route of administration for a typical study participant 
NA 
iii. 
If not FDA approved: dosimetry information and source documents (package insert, 
Medical Internal Radiation Dose [MIRD] calculation, and peer reviewed literature) 
NA 
c. 
Radiation Machines – Diagnostic Procedures 
i. 
Examination description (well-established procedures) 
NA 
ii. 
Total number of times each procedure will be performed (typical study participant) 
NA 
iii. 
Setup and techniques to support dose modeling 
NA 
iv. 
FDA status of the machine and information on dose modeling (if procedure is not 
well-established) 
NA 
d. 
Radiation Machines – Therapeutic Procedures 
i. 
Area treated, dose per fraction/number of fractions, performed as part of normal 
clinical management or due to research participation (well-established procedures) 
NA 
ii. 
FDA status of the machine, basis for dosimetry, area treated, dose per fraction and 
number of fractions (if procedure is not well-established) 
NA 
5. 
DEVICES USED IN THE STUDY 
a. 
Investigational Devices (Including Commercial Devices Used Off-Label) 
Investigational Device 1 
Name: 
Nasal Airway Stent 
Description: 
The Nasal Airway Stent (NAS) is inserted into the nose and serves as a 
mechanical splint to prop open the upper airway. 
Significant Risk? (Y/N) 
No 
Rationale for Non-Significant Risk 
Device does not provide for any significant risk. The device is extremely 
soft and flexible and would be highly unlikely to cause any problems 
with the soft palate, throat, and/or upper airway. 
 
b. 
IDE-Exempt Devices 

October 27, 2016 
 
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IND-Exempt Device 1 
Name: 
NA 
Description: 
NA 
 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
a. 
Investigational Drugs, Biologics, Reagents, or Chemicals 
Investigational Product 1 
Name: 
NA 
Dosage: 
NA 
Administration Route: 
NA 
b. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
Commercial Product 1 
Name: 
NA 
Dosage: 
NA 
Administration Route 
NA 
New and different use? (Y/N) 
NA 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
Not Applicable 
 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
Our plan is to enroll 30 patients for the NAS study at Stanford. Stanford will be the only 
site. The population will be 18 years of age and older with snoring and obstructive sleep 
apnea and exclusion criteria of adults with body mass index (BMI) greater than 30 
kg/m2. 
b. 
Age, Gender, and Ethnic Background 
Age range is 18 years and older. There are no gender or ethnic background specific 
criteria. 
c. 
Vulnerable Populations 
- No children will be asked to participate in the study. 
- Pregnant women, homeless and economically disadvantaged people will be excluded. 
- Persons who are not able to comprehend or understand English. 
- Persons who are unable to follow instructions will be excluded. 
- Persons with body mass index greater than 30 kg/m2 will be excluded. 
d. 
Rationale for Exclusion of Certain Populations 
No children will be included in the study, since standard-of-care treatment for sleep 
disorder management in children is less well defined and standardized than that of adults. 

October 27, 2016 
 
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e. 
Stanford Populations 
Laboratory personnel, employees, and/or students will not be excluded from the study, 
since they will be part of our normal clinic population. No specific number or share of 
laboratory personnel, employees, and/or students can be part of the study. 
 
Those participants in this research study will also be eligible for the standard study 
cooperation fee of $700 and the option of receiving nasal stents after their second sleep 
study. 
 
Payments may only be made to U.S. citizens, legal resident aliens, and those who have a 
work eligible visa. 
f. 
Healthy Volunteers 
Not Applicable 
g. 
Recruitment Details 
Potential participants will be recruited from the Stanford Sleep Medicine Center clinic 
population as identified via chart review by the research staff. During their clinic visit, 
only someone with a treating relationship will initially approach the potential subject and, 
after they have indicated that they are interested in more information about the study, 
they will contact the research staff or agree to allow their physician to provide their 
contact information to the research personnel. 
 
In addition, recruitment flyers will be posted in local businesses, as well as running a 
subject recruitment newspaper ad to obtain subjects outside of the Stanford Sleep 
Medicine Center clinic population. The phone number and email address of the research 
coordinator will be on the ads for the interested participant to contact. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
The population under study will be clinical outpatients 18 years of age or older with 
symptoms of obstructive sleep apnea and snoring, and with body mass index less 
than 30 kg/m2. 
ii. 
Exclusion Criteria 
Children, pregnant women, homeless, economically disadvantaged individuals, and 
those who are unable to comprehend or understand English, or follow instructions 
will be excluded. Persons with body mass index greater than 30 kg/m2 will also be 
excluded. 
i. 
Screening Procedures 
Patients at age over 18 will be screened. Clinical outpatients will be recruited from our 
normal clinic population. No telephone screening will be performed. In addition, flyers 
will be posted to recruit subjects outside of our normal clinic population. 

October 27, 2016 
 
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j. 
Participation in Multiple Protocols 
Our research team will ask this question, and this question will be on our informed 
consent form. Patients will be given the choice as to whether they want to participate in 
this study if they are already enrolled in another study. 
k. 
Payments to Participants 
The patient will be paid to participate in this research study. It is a cooperation fee of 
$700. The payments will be prorated based on the length of participation. Payments may 
only be made to U.S. citizens, legal resident aliens, and those who have a work eligible 
visa. Patients may need to provide their social security number to receive payment. 
 
Participants will have the option to receive the nasal device after the second sleep study. 
The participant will be allowed to receive complimentary nasal stents until the time the 
device becomes commercially available. 
l. 
Costs to Participants 
There is no cost for participating in this study, other than basic expenses like 
transportation and the personal time it will take to come to all of the study visits. The 
study will pay for those services, supplies, procedures, and care associated with the study 
that are not a part of routine medical care. The patient will be responsible for any co-
payments and/or deductibles as required by your insurance. 
m. 
Planned Duration of the Study 
The consenting time will take about 15 minutes. 
 
This research study is expected to last approximately one year. The active participation is 
up to a year. The time for the sleep questions will be about 30 minutes - the sleepiness 
scale will take about 5 minutes and the electronic questionnaire will take approx. 20 Min. 
The limit use of this device is a maximum of 10 hours - every night throughout the whole 
night for 7 days. At baseline and day 8 the patient will be requested to have sleep studies 
(without the NAS at baseline and while wearing the NAS at day 8). 
9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
If you insert the NAS into the nostril there can be a little nose bleeding because of the 
damage of the mucous membrane while inserting the NAS device. 
 
There may be some soreness and swelling due to the pressure of the device. 
ii. 
Investigational drugs 
Not Applicable 
iii. 
Commercially available drugs, biologics, reagents or chemicals 

October 27, 2016 
 
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Commercially available drugs will be used as part of normal sleep disorder treatment. 
This is not a clinical trial to test medications, so routine medications for the treatment of 
sleep disorders will be prescribed by the subject's physician as part of their clinical care 
only. 
iv. 
Procedures 
Insertion of the NAS tube to the appropriate side of the nostril. 
v. 
Radioisotopes/radiation-producing machines 
Not Applicable 
vi. 
Physical well-being 
There can be a little nose bleeding because of the damage of the mucous membrane. 
 
There may be some soreness and swelling due to the pressure of the device. 
vii. 
Psychological well-being 
No appreciable risks 
viii. 
Economic well-being 
No appreciable risks 
ix. 
Social well-being 
No appreciable risks 
x. 
Overall evaluation of risk 
Low - innocuous procedures such as phlebotomy, urine or stool collection, no therapeutic 
agent, or safe therapeutic agent such as the use of an FDA approved drug or device. 
b. 
International Research Risk Procedures 
Not Applicable 
c. 
Procedures to Minimize Risk 
This is a low-risk study, given that the participants will have procedures described above 
that are part of normal routine medical care. 
 
Protections Against Risks 
 
Treatment: We will have close monitoring of the participants while they are on treatment, 
including regularly scheduled visits to our center to maintain safety and adherence. 
Testing Information: We will keep all of the information collected about the participants 
in locked files at our center. For computerized data, the data will be stored in password-
protected computers at our center. 
 
Further, staff will have completed human subjects training. 

October 27, 2016 
 
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d. 
Study Conclusion 
The study will terminate when we have successfully enrolled 30 patients for the NAS 
study. 
 
The Protocol Director will be monitoring all safety data from Stanford participants, and 
will determine if it remains safe for a subject to continue. A subject would be 
discontinued from the protocol at any time if it is determined that subject safety is at risk. 
The protocol director and/or study coordinator will be reachable by cell phone 24/7 by 
subjects. 
 
Regarding an adverse/unexpected event, the lab personnel typically become aware of the 
event directly from the participant or the participant's healthcare provider. Upon 
becoming aware of an adverse event, the principal investigator should assess whether the 
adverse event represents an unanticipated problem: 
1. unexpected; 
2. related or possibly related to participation in the research; and 
3. serious or otherwise one that suggests that the research places subjects or others at a 
greater risk of physical or psychological harm than was previously known or recognized. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
Data Collected From the Participant. Data from forms, questionnaires, and interviews 
will be entered into a secure, password-protected web portal. All data will also be 
collected and transferred in compliance with the Health Insurance Portability and 
Accountability Act (HIPAA). 
ii. 
Person(s) responsible for Data and Safety Monitoring 
The protocol director 
iii. 
Frequency of DSMB meetings 
Not Applicable 
iv. 
Specific triggers or stopping rules 
Within 24 hours of learning of a death, or within 5 days of learning of an 
unanticipated problem involving risks to participants or others. 
v. 
DSMB Reporting 
Not Applicable 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Not Applicable 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 

October 27, 2016 
 
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Not Applicable 
f. 
Risks to Special Populations 
Not Applicable 
10. 
BENEFITS 
Study participants will not receive direct benefit; however future sleep medicine patients may 
benefit. This information about NAS (nasal stent) appears to be a useful alternative or additive 
treatment for patients with OSA. We hope to gain through this study if this new device provides a 
better or alternative treatment of OSA. 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.