Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: InnoMed Healthscience Inc.

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Title: Clinical study for the BONGO device in the treatment of obstructive sleep apnea 
 
 
Funding Sponsor: 
InnoMed Healthscience 
6601 Lyons Road, Buildings B1 - B4  
Coconut Creek, FL 33073 
 
Study Product: 
BONGO  
Protocol Number: 
INN-C003V1.0 
Primary Investigators: 
Jerrold Kram MD 
California Center for Sleep Disorders 
985 Atlantic Ave. 
Suite 250 
Alameda, CA 94501 
(510) 263-3300 
 
Date of Original Version V1.0: July 11, 2016 
 
 
 
 
 
 
 
 
 

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Study Acknowledgement and Signature Page 
 
I understand that this protocol may contain information that is confidential and 
proprietary to InnoMed Healthscience. 
 
I have read this protocol and agree that it contains all of the components and details 
necessary to conduct the study as described.  I will conduct the study according to good 
clinical practices and any regulatory requirements deemed necessary.   
 
This is to include supervision of staff participating in this research project, completion of 
the case report forms/data collection forms, obtaining Institutional Review Board (IRB) 
approval prior to enrolling any subject and make all attempts to conduct within the time 
frames allocated.  I further agree to keep confidential any information gleaned from the 
conduct of the study and/or InnoMed Healthscience.  
 
I have read this clinical investigational protocol and fully agree with the contents. 
 
 
_______________________________________ 
Printed Name of Investigator 
 
 
_______________________________________    ________________________ 
Investigator Signature 
 
 
 
 
 
 
Date Signed 
 
 
 
Protocol Number INN-C003V1.0 
 
 
 
 
 
 
 
 

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Table of Contents 
 
STUDY ACKNOWLEDGEMENT AND SIGNATURE PAGE .........................................................................  
1 
LIST OF ABBREVIATIONS ...................................................................................................................  
2 
STUDY SUMMARY .............................................................................................................................. 6 
3 
INTRODUCTION .................................................................................................................................. 7 
3.1 
BACKGROUND ..................................................................................................... 7 
4 
STUDY OVERVIEW ........................................................................................................................... 10 
4.1 
STUDY OBJECTIVES ........................................................................................... 10 
4.2 
PRIMARY ENDPOINT........................................................................................... 11 
5 
STUDY DESIGN AND PROCEDURAL DETAIL ............................................................................... 11 
5.1 
STUDY OUTLINE AND DESIGN ............................................................................. 11 
5.2 
SUBJECT RECRUITMENT AND SCREENING ............................................................ 11 
5.3 
METHOD FOR ASSIGNING SUBJECTS ................................................................... 11 
5.4 
CONCOMITANT THERAPY .................................................................................... 11 
5.5 
BLINDING OF STUDY .......................................................................................... 11 
6 
SCREENING AND VISITS ................................................................................................................. 11 
6.1 
SCREENING/BASELINE ....................................................................................... 11 
6.2 
PSG STUDIES ................................................................................................... 12 
6.3 
STUDY TERMINATION VISIT ................................................................................. 16 
6.4 
SUBJECT SELECTION ......................................................................................... 16 
6.5 
INCLUSION CRITERIA .......................................................................................... 16 
6.6 
EXCLUSION CRITERIA ........................................................................................ 16 
7 
TASK AND VISIT SCHEDULE TABLE ............................................................................................. 17 
8 
STATISTICAL PLAN ......................................................................................................................... 17 
8.1 
SAMPLE SIZE .................................................................................................... 17 
9 
SUBJECT COMPLIANCE MONITORING ......................................................................................... 18 
9.1 
EARLY WITHDRAWAL OF SUBJECTS .................................................................... 18 
9.1.1 
When and How to Withdraw Subjects ................................................................................... 18 
9.1.2 
Data Collection and Follow-up for Withdrawn Subjects ........................................................ 18 
10 
RISKS/BENEFITS .............................................................................................................................. 18 
11 
SAFETY AND ADVERSE EVENTS ................................................................................................... 19 
11.1 
DEFINITIONS ..................................................................................................... 19 
11.2 
RECORDING OF ADVERSE DEVICE EFFECTS ........................................................ 20 
11.3 
REPORTING OF ADVERSE DEVICE EFFECTS AND UNANTICIPATED PROBLEMS ......... 20 
11.3.1 Investigator reporting: Notifying the study sponsor ............................................................... 20 
11.3.2 Investigator reporting: Notifying the IRB ............................................................................... 21 
12 
RECEIVING, STORAGE, DISPENSING AND RETURN ................................................................... 21 

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12.1 
PACKAGING ...................................................................................................... 21 
12.2 
RECEIPT OF STUDY PRODUCT ............................................................................ 21 
12.3 
DISPENSING OF STUDY PRODUCT ....................................................................... 21 
12.4 
RETURN OF STUDY PRODUCT ............................................................................. 22 
13 
DATA HANDLING AND RECORD KEEPING ................................................................................... 22 
13.1 
CONFIDENTIALITY .............................................................................................. 22 
13.2 
SOURCE DOCUMENTS ........................................................................................ 22 
13.3 
CASE REPORT FORMS ....................................................................................... 22 
13.4 
RECORDS RETENTION ....................................................................................... 22 
14 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 23 
14.1 
STUDY QUALITY/MONITORING PLAN .................................................................... 23 
14.2 
AUDITING AND INSPECTING ................................................................................. 23 
15 
ETHICAL AND REGULATORY CONSIDERATIONS ....................................................................... 23 
16 
STUDY FINANCES ............................................................................................................................ 24 
16.1 
FUNDING SOURCE ............................................................................................. 24 
16.2 
CONFLICT OF INTEREST ..................................................................................... 24 
16.3 
SUBJECT STIPENDS OR PAYMENTS ..................................................................... 24 
17 
PUBLICATION PLAN ........................................................................................................................ 24 
18 
REFERENCES ................................................................................................................................... 25 
 
 
 

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1 List of Abbreviations 
AHI 
Apnea Hypopnea Index 
APAP 
Auto-titrating CPAP  
CFR  
Code of Federal Regulation 
CPAP 
Continuous Positive Airway Pressure 
CRF 
Case Report Form(s) 
CV 
Clinic Visit 
EPAP 
Expiratory positive airway pressure 
GCP 
Good Clinical Practice(s) 
ODI 
Oxygen desaturation index 
OSA 
Obstructive sleep apnea 
PHI 
Protected Health Information 
PSG 
Polysomnogram 
IRB 
Institutional Review Board 
 
 
 
 
 
 
 

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2 Study Summary 
Title 
Clinical study for the BONGO device in the treatment of 
obstructive sleep apnea.  
Short Title 
Clinical Study – BONGO Device  
Protocol Number 
INN-C003 
Methodology 
Prospective, non-randomized, open label study 
Study Center(s) 
1 
Primary Endpoint 
AHI with Bongo at PSG 2 compared to baseline study 
Number of Subjects Up to 10 subjects who complete 
Diagnosis and Main 
Inclusion Criteria 
• ≥ 21 years of age 
• Diagnosis of mild to moderate obstructive sleep apnea via a 
PSG within the last 12 months 
Study Product 
/Indication for Use 
BONGO NASAL EPAP Device 
Intended for adult patients for the treatment of mild to moderate 
obstructive sleep apnea 
Control/Comparator None 
 

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3 Introduction 
This document is a protocol for a human research study. This study is to be conducted 
according to US (21 CFR Part 812) and international standards of Good Clinical 
Practice (International Conference on Harmonization ICH-E6, ISO 14155 and other 
applicable government regulations, and Institutional research policies and procedures).  
3.1 Background 
Sleep is a necessary component of good health and comprises about one-third of a 
human life.  The average person sleeps about 3000 hours per year; thus, the 
importance of sleep should not be underestimated.  Adequate quantity and quality of 
sleep is essential to most psychological and physiological processes.  Obstructive sleep 
apnea (OSA) is a common and serious condition that impairs sleep and can 
compromise an individual’s health.      
OSA can be characterized by a periodic full closure or partial obstruction in the upper 
airway due to neurological and/or anatomical features factors including micro- and 
retrognathia and impaired neuromodulation to the upper airway.  Risk factors also 
include obesity, male, or post-menopausal females, age, neck size, and upper airway 
malformations such as deviated septum (Epstein, et al., 2009; Kapur, 2010).  The 
obstruction or upper airways resistance results in cyclical reductions in blood oxygen, 
increased work of breathing, and arousals (cortical and sympathetic) from sleep.  These 
sequelae may in turn have short- or long-term results such as insulin resistance, type 
two diabetes, stroke, incident coronary heart disease in men, neurocognitive deficits, 
and hypertension.  Along with damage to health, these conditions may and also have 
significant negative workplace and economic consequences (Gottlieb et al., 2010; 
Marin, et al., 2005; Redeker & McEnany, 2011; Redline et al., 2010; Rosekind, et al., 
2010; Yaggi;, 2005). 
Continuous positive airway pressure (CPAP) is the most often frequently prescribed 
therapy for OSA.  CPAP provides a pneumatic splint to the upper airway, thus 
preventing closure due to critical closing pressure.  Other therapeutic options include 
oral appliances, surgical procedures, and, most recently, expiratory positive airway 
pressure (EPAP) devices (Provent K071560; K080983; K090398; K102404, Theravent, 
San Jose).   
While CPAP is considered the therapy of choice, adherence to short-term (acclimation) 
and long-term therapy remains problematic (Somers, Peterson, Sharma & Yaramchuc, 
2011).  Rates of adherence, defined as usage of at least 4 hours for 70 percent of the 
nights, are reported to average between 30% and 60%; one study found that 31% of 
their population did not fill their prescription for CPAP (Sin, Mayer, Man & Pawluk, 2002; 
Wolkove, Baltzan, Kamel, Dabrusin & Palayew, 2008).  Thus there is still an opportunity 
to improve therapeutic targets for patients with OSA. 
Expiratory positive airway pressure (EPAP) is such a therapeutic target.  Data support 
the use of the EPAP for the treatment of OSA.  At least two potential mechanisms of 
action have been suggested. One of these is increased functional residual capacity, 

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which produces tracheal traction, resulting in lessened propensity for upper 
airway/pharyngeal collapse. An alternative mechanism is passive dilation of the airway, 
which reduces flow limitation (Braga, Chen, Burschtin, Rapoport & Ayappa, 2011; 
Colrain, Brooks & Black, 2008; Heinzer et al., 2008; Owens et al., 2012; Rosenthal, 
Massie, Dolan, Loomas, Kram & Hart, 2009; Walsh et al., 2011).   
The Provent device provides for an “unimpeded flow of air during inhalation, but closes 
so that exhalation occurs against a fixed orifice” thus creating EPAP (Rosenthal, et al, 
2009).  The Provent device is comprised of two nasal inserts which are affixed to the 
nares via adhesive, each containing an actuated valve. Several studies provide the 
long-term (up to 12 months) effectiveness of Provent versus sham devices in 
multicenter trial with up to 250 subjects enrolled.  These studies demonstrated an 
effective therapeutic approach in reducing the apnea hypopnea values (Berry et al., 
2010;Kryger, et al., 2011).  These studies further demonstrated that no serious adverse 
events occurred over the span of the study.  
The BONGO NASAL EPAP device was developed to provide similar principals of 
operation and is posited to be substantially equivalent to the Provent device. This 
mechanism provides for minimal inhale resistance and controlled exhale resistance 
which increases expiratory airway pressure upon exhalation as noted above. 
The Bongo differs from the Provent in that it is reusable, does not use adhesive, and 
seals against the opening of the nares instead of the outer edges of the nares and nose. 
During product development, bench testing was conducted on the Bongo, including age 
testing, environmental testing (high temperature, low temperature, and humidity), cycle 
testing, drop testing, and cleaning testing. Comparative testing against the Provent 
device was also conducted including inhale resistance testing and exhalation flow rate 
testing. 
3.2 Investigational Product Description 
The BONGO NASAL EPAP device consists of two nasal inserts (a connected pair), 
each containing an actuated valve, with a patient attachment mechanism.  The device 
works by providing an inhalation port that offers minimal inhale resistance during 
inhalation, but is closed by the actuated valve so that exhalation occurs against a fixed 
orifice.  This mechanism provides increased EPAP upon exhalation. 
The design incorporates elements of the currently marketed Nasal-Aire II (K022465).  
The Nasal-Aire II is a nasal interface that delivers positive pressure from the CPAP 
machine to the patient.  The materials to be used in the investigational product are 
similar to those in the currently marketed product.  Like the Nasal-Aire II, the Bongo will 
seal against the nares.  
 
 

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Nasal-Aire II 
 
 
Nasal-Aire II in Use 
Nasal Inserts of Nasal-Aire II 
 
 
Bongo Renderings 
 
 
 
Top View 
Bottom View 
 

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Front View 
Exploded View 
(Nasal Inserts in Yellow 
Valves in Gray) 
 
 
 
Cross-section showing Valve OPEN 
Cross-section showing Valve CLOSED 
 
The Bongo is made of silicone and polypropylene.  A total of four (4) nasal insert sizes 
(SM, MD, LG, and XL) will be available during this study.  Subjects will fit the most 
appropriate size for comfort during the first clinic visit.  A total of two (2) valves with 
different resistances (R1 and R2) will be available during this study. Each nasal insert 
size will have the capability to use each resistor for a total of 8 variations (e.g. Nasal 
Insert MD will have R1 and R2 options). 
4 Study Overview 
4.1 Study Objectives 
The objective for this study is to provide the data required for inclusion within a pre-
market notification (510k) submission. The study design and end points have previously 
been discussed with the Food and Drug Administration.  

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4.2 Primary Endpoint 
The primary endpoint for the study is change in AHI, defined as the difference in AHI 
between the diagnostic study and PSG 2 with the Bongo. A reduction in AHI to less than 
10 or an AHI reduction by at least 50% from the baseline is considered clinically 
significant. 
5 Study Design and Procedural Detail 
5.1 Study Outline and Design 
This study is a prospective, non-randomized, open label, single-center clinical study for 
the BONGO NASAL EPAP device for the treatment of obstructive sleep apnea.  
 
Subjects will have the following study schedule: 
1. Screening 
2. In-lab PSG 1 with the Bongo 
3. 2 week at home use of the Bongo 
4. In-lab PSG 2 with the Bongo 
5. Study termination visit (may be completed the morning following PSG 2)  
5.2 Subject Recruitment and Screening 
Subjects will be recruited from existing patient rolls within the participating sleep center.  
The patient rolls provide the first line of screening for inclusion criteria and exclusion 
criteria. Phone screening will be conducted to further assess meeting the inclusion 
criteria and exclusion criteria (e.g. do they use a full face mask or are they mouth 
breathers).Additional screening will be conducted during the screening visit.  Data 
obtained from screening will not be retained and the site will follow their standard 
procedures for destroying the data.  
5.3 Method for Assigning Subjects 
Subjects will not be randomized for this study 
5.4 Concomitant Therapy 
Subjects will take their medications as normal 
5.5 Blinding of Study 
This study is open-label  
6 Screening and Visits 
6.1 Screening/Baseline 
Subjects will be first phone screened using existing patient rolls at each individual sleep 
center. Subjects who meet the initial qualifications will be asked to attend an in-clinic 
visit (Screening Visit).   
 

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During this Screening Visit the following will occur: 
• Informed Consent Process 
• Subjects will be asked to bring their CPAP/APAP machines and/or their data card 
for downloading and review. The following data from the past 30 days will be 
downloaded: pressure setting, average hours of use per night, % of time used, 
and residual AHI. If the subject has no data on their data card over this time 
period, and/or the subject has been diagnosed and is unable or willing to use 
CPAP, this will be noted on their record. 
• Subjects will fit for the nasal inserts: 
o Subjects will select the size of the BONGO according to Bongo IFU 
o Subjects will be allowed a minimum of 10 minutes of acclimation with the 
valve R1; ensure that subject has some “supine” time during the 
acclimation period. 
o Subjects will be asked on a scale of 1-10 where their tolerability level of 
the device resides (<5, not qualified;≥5, will qualify to move ahead).  
• Once a subject is deemed eligible to participate, baseline measurements 
including BMI, vital signs, medications, and the above measures will be recorded.   
6.2 PSG Studies 
Two in-lab PSG studies will be performed while using the Bongo device. PSG 1 will be 
performed on a separate visit after the Screening Visit. PSG 2 will be performed after a 
two week (14 day) period of at home use with the Bongo. 
 
Sites will follow the standard sleep protocol methods that include patient preparation 
procedures, the standard recording montage, the proper instrument calibration and bio-
calibration procedures that must precede the initiation of the collection of the PSGs 
according to the American Academy of Sleep Medicine (AASM) Manual for Scoring 
Sleep and Associated Events (2007), a standard PSG montage, recording channel 
labels and the order to be used will be:  
• 
left electrooculogram (E1/M2) 
• 
rightelectrooculogram (E2/M1) 
• 
submental electromyogram (chin1/chin2) 
• 
submental electromyogram (chin2/chin3) 
• 
electroencephalogram (C3/M2) 
• 
electroencephalogram (O2/M1) 
• 
electroencephalogram (F4/M1) 
• 
electroencephalogram (C4/M1) 
• 
electrocardiogram (ECG) 

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• 
thoracic inductance plethysmography (TEFFORT) 
• 
abdominal inductance plethysmography (AEFFORT)  
• 
nasal/oral nasal air pressure transducer (PFLOW),  
• 
oxygen saturation (SaO2) 
• 
left  anterior tibialis electromyogram (L LEG) 
• 
right anterior tibialis electromyogram (R LEG) 
Prior to each PSG, the site will screen the subject for acute alcohol intoxication by 
obtaining a breath alcohol test or equivalent. If testing shows any evidence of recent 
alcohol use, then the subject will be sent home after being counseled to refrain from 
alcohol use and return to the site within one week for the PSG. Subjects will be allowed 
no more than two attempts to participate if they are intoxicated upon arrival to the sleep 
clinic.  
In addition, prior to each PSG, the site will call the subject to remind them of the 
upcoming PSG, they will be asked if they have any current cold or nasal condition which 
would prevent them from attending. At the time of the PSG, the research staff will 
assess the subject for nasal infection, nasal congestion, or nasal allergies that may 
impact the ability of the subject to breathe through the nose. If observation shows any 
evidence of nasal infection, nasal congestion, or nasal allergies, then the subject will be 
sent home and asked to return to the site after the symptoms have resolved. 
A standard type pre (PM) sleep questionnaire will also be completed at a PSG visit. This 
questionnaire will assess the subjects day of test activity. 
To record data during a PSG with the Bongo, a sampling tube connecting the nasal 
insert to the pressure transducer is used.  Each nasal insert has a sampling port for 
connecting a sampling tube.  The sample tubes and instructions for use will be supplied 
by InnoMed to the site for this purpose. 
 
During PSG 1:  
1. Subjects may sleep in the position that is the most comfortable for them. 
2. All subjects will begin with the R1 valve in place.   
3. Subjects will sleep with the R1 valve until the completion of one REM cycle. 
Calculate the AHI at this time. 
a. If the AHI is below 10 (AHI < 10), maintain the R1 valve. 
b. If the AHI equals or exceeds 10 (AHI ≥ 10), change to the R2 valve for the 
remainder of PSG 1. 
4. Continue to calculate the running AHI of subjects that remained on the R1.  
a. If the running AHI equals or exceeds 10 (AHI ≥ 10), change to the R2 
valve for the remainder of PSG 1. 

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5. At the end of PSG 1 and prior to the subject leaving the facility: 
a. Calculate and record the AHI for the overall time the R1 valve was used. 
b. If applicable, also calculate and record the AHI for the overall time the R2 
valve was used. (Note that the AHI for R1 and R2 should not be 
combined).  
 
 
Study Initiated with R1 
 
Completion of first REM 
cycle 
Change to R2; continue to 
the end of study  
Continue with R1  and 
monitor. 
If AHI ≥ 10 
If AHI < 10 
Calculate and record the overall AHI for R1. 
 
Calculate and record the overall AHI for R2 (if applicable). 
 
(Note that the AHI for R1 and R2 should not be combined). 
If the running AHI ≥10 using 
R1, then switch to R2. 
 

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Prior to the subject leaving the facility, the research staff will need to score and assess 
whether the subject qualifies for the at home portion of the study. Score using the 
AASM 3% and/or arousal criteria.  
 
1. Compare R1 AHI, as well as the R2 AHI (if applicable), to the subject's baseline AHI 
(from their diagnostic study). 
2. If the subject while using the Bongo had an AHI reduction to less than 10 (AHI < 10) 
or an AHI reduction by at least 50% (AHI reduction ≥50%) compared to the baseline, 
then the subject qualifies for the at home portion of the study. 
a. Send the subject home with either the R1 or R2 valve only, whichever valve 
the subject had the lowest AHI with.  
3. If the subject did not have the AHI reductions described above with either valve, then 
that subject will be terminated from the remainder of the study. 
 
Subjects that qualify for the at home portion of the study will continue using the Bongo 
at home for two weeks. Subjects will complete a daily use log while using the Bongo at 
home. 
Enrollment will continue until such time a total of up to 10 subjects have completed all 
components of the study. 
In preparation for the home use portion of the study, the site will: 
• Remove the sampling tubes from the Bongo and cover the Bongo sampling ports 
with caps provided by InnoMed prior to the subject going home 
• Subjects will be provided with the instructions for use. 
• Instruct the subject to call the site if any adverse events are experienced. 
After two weeks (14 days) of at home use with the Bongo, the subjects will return with 
their Bongo unit and daily use log to the site for PSG 2. PSG 2 should be conducted no 
later than three days (14+3 days) after the end of the at home use portion of the study. 
 
During PSG 2:  
1. All subjects will use either the R1 or the R2 valve (the same device) that they 
have been using during the at home use period for the entirety of PSG 2. 
2. Subjects may sleep in the position that is the most comfortable for them. 
3. Calculate and record the AHI for the overall time. 
 
Score using the AASM 3% and/or arousal criteria. PSG 2 studies to be scored no more 
than 3 days following the PSG 2.  

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6.3 Study Termination Visit 
The purpose of this visit is to visually inspect the skin/nares and query the subject as to 
any adverse events they may have encountered and to complete the study.  This visit 
may be conducted on the morning after the completion of their final PSG or via a 
separate clinic visit. 
6.4 Subject Selection 
As noted, subjects will be recruited from existing rolls and up to 20 subjects may be 
enrolled with a targeted number up to 10 subjects who complete the study.   
6.5 Inclusion Criteria 
• Capacity and willingness to sign informed consent 
• ≥ 21 years of age 
• Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of 
the screening visit with the 3% hypopnea criteria 
• Able to tolerate using the device during a day time trial/acclimation 
• Are currently using CPAP or have been prescribed CPAP and are considered 
CPAP non-adherent (as per either their CPAP data card and/or verbal 
confirmation of a diagnosis and unwillingness to use CPAP) 
6.6 Exclusion Criteria 
• Nasal deformities 
• Severe nasal allergies 
• Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, 
sinus or middle ear) inflammation or infection, or perforation of the ear drum 
• Co-morbid sleep disorders 
• Currently on a hypnotic for insomnia (who have had insomnia for more than a 
month and take a hypnotic on a daily basis and/or transient insomnia being 
treated) 
• Uncontrolled or serious illness, including but not limited to: severe breathing 
disorders including hypercapnic respiratory failure, respiratory muscle weakness, 
bullous lung disease (as seen in some types of emphysema), bypassed upper 
airway, pneumothorax, pneumomediastinum, etc.; severe heart disease 
(including heart failure); or pathologically low blood pressure. 
• Full Face Mask user 
• Mouth breather 
• Pregnant (Female subjects of child bearing age will be asked if they are and/or 
planning on becoming pregnant during the study; acceptable methods of birth 
control include birth control pills and barrier method) 
 
 

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7 Task and Visit Schedule Table 
 
 
Screening 
Visit  
PSG 1 
2 week in 
home use 
PSG 2 
Term. Visit* 
TASK 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
CPAP usage verification, 
AHI(data download)  
X 
 
 
 
 
Bongo Fit 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Vital signs 
X 
 
 
 
 
Height/Weight (BMI) 
X 
 
 
 
 
Medical History  
X 
 
 
 
 
Concomitant Medications 
X 
 
 
 
X 
PM Questionnaire/ETOH 
assessment 
 
X 
 
X 
 
PSG/Scoring 
 
X 
 
X 
 
Preparation for Home 
Use AM Tasks 
 
X 
 
 
 
CRF Completion 
 
X 
 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Daily Use Diary(Subject) 
 
 
X 
 
 
Daily Diary (review) 
 
 
 
 
X 
MD CRF review/Sign off 
 
 
 
 
X 
 
*May have this visit taking place the AM of the sleep study or in the clinic. 
8 Statistical Plan 
The primary aim of this study is to assess objective sleep parameters while sleeping 
with the BONGO NASAL EPAP device (Test product).  The primary endpoint to be 
evaluated is AHI compared to baseline data. Baseline demographic will be summarized 
and reported. For continuous variables such as weight, the mean, standard deviation 
and range will be presented. For categorical variables such as gender, the proportion of 
subjects in each category will be presented.  Descriptive statistics for sleep study data 
will be reported. 
8.1 Sample Size 
Up to 20 subjects may be enrolled in the study with a targeted number up to 10 subjects 
who complete the study and are deemed evaluable. A study with 10 subjects was 
proposed and accepted by the FDA for the data required for inclusion within a pre-
market notification (510k) submission for the Bongo. 
 

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9 Subject Compliance Monitoring 
Compliance for subject participation will be assessed at each visit.  
9.1 Early Withdrawal of Subjects 
Although early withdrawal of subjects is not anticipated, for subjects who withdraw prior 
to completion of their participation, data collected to date will be included.  If the 
withdrawal is due to medical reasons, appropriate referral to their primary care 
physician will be done.  
9.1.1 When and How to Withdraw Subjects 
A subject may withdraw from the study at any time and for any reason.  Explanation of 
such rights will be given to the subject during the informed consent process, both 
verbally and in writing.  If subjects decide that they no longer wish to participate in the 
study, they will be asked to return for a final visit. If they are unable to comply with this 
request, a study termination letter will be sent to their given address. A request for the 
study documents will be made.  
9.1.2 Data Collection and Follow-up for Withdrawn Subjects 
Data will cease to be collected upon subject withdrawal of informed consent; however, 
data collected until the time of withdrawal will be used as appropriate and will be 
reported in the clinical study report. 
10 Risks/Benefits 
Risks 
Known risks include: 
• Breach of confidentiality.  It is possible that information regarding subjects’ clinical or 
laboratory evaluations will be discovered by individuals outside of study personnel, 
despite careful steps to protect confidentiality.  
• Polysomnography: Some subjects experience mild skin irritation from electrode 
preparation solution, electrode adhesive, or solvents used to remove electrodes.  
These materials can also cause eye irritation if they come into contact with the eyes. 
This is a standard test for ascertaining sleep disorders in clinical practice and is 
widely used. Sleeping within a laboratory setting may produce psychological 
discomfort for some subjects. 
• Subjects may feel some psychological discomfort just by the fact that they are 
participating in research. Such concerns include confidentiality and privacy, clinical 
intervention or tests adverse effects from the investigational product.  
Possible Anticipated Device adverse events include: 
• Headache 
• Sinus Allergy 
• Irritation of the nares from the nasal inserts 
 

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Benefits 
Benefits include evaluation of current apnea status  
11 Safety and Adverse Events 
11.1 Definitions 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency (i.e. not described in study-related 
documents such as the IRB-approved protocol or consent form, the investigators 
brochure, etc…) 
• Related or possibly related to participation in the research (i.e. possibly related 
means there is a reasonable possibility that the incident experience, or outcome 
may have been caused by the procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm 
(including physical, psychological, economic, or social harm). 
 
Unanticipated Adverse Device Effect 
An Unanticipated Adverse Device Effect is any serious adverse effect on health or 
safety, or any life-threatening problem or death caused by or associated with a product, 
if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem associated with a 
product that relates to the rights, safety, or welfare of subjects. 
 
Serious injury 
Any injury or illness that is any one of the following:  
• life-threatening 
• results in permanent impairment of a body function or permanent damage to body 
structure 
• necessitates medical or surgical intervention to preclude permanent impairment of 
a body function or permanent damage to a body structure 
 
Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience that develops or 
worsens in severity during the course of the study.  Intercurrent illnesses or injuries 
should be regarded as adverse events.  Abnormal results of diagnostic procedures are 
considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse Product effect 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 

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11.2 Recording of Adverse Device Effects 
At each contact with the subject, adverse events will be assessed. Data will be 
documented on an adverse event form and the subject chart.  Any and all clearly study 
related signs, symptoms, and abnormal diagnostic procedures results should be 
recorded in the source document; however, events related to each other should be 
grouped under one diagnosis. 
 
All adverse Product effects occurring during the study period will be recorded.  The 
clinical course of each event will be followed until resolution or stabilization or until it has 
been determined that the study treatment or participation is not the cause.  Serious 
adverse Product effects that are still ongoing at the end of the study period will be 
followed to determine the final outcome.  Any serious adverse Product effects that occur 
after the study period should be recorded and reported promptly (see section 8.3 
below). 
11.3 Reporting of Adverse Device Effects and Unanticipated Problems 
11.3.1 Investigator reporting: Notifying the study sponsor 
Any events which are noted by the investigator will be reported to the sponsor not more 
than 10 days after learning of the event.   
 
Sponsor contact information for reporting purposes 
Report adverse Product effects by phone and facsimile to: 
 
InnoMed Healthscience 
800-200-9842 phone 
877-868-8406 fax 
 
Adverse Product Effects 
Any adverse Product effect that results in serious injury or death, and any type of 
unanticipated adverse Product effect, regardless of seriousness or severity, must be 
reported to the study sponsor by telephone within 24 hours of the event.   
 
Within the following 48 hours, the investigator shall provide further information, as 
applicable, on the unanticipated Product event or the unanticipated problem in the form 
of a written narrative.  This should include a copy of the completed Unanticipated 
Problem form, and any other diagnostic information that will assist the understanding of 
the event.  Significant new information on ongoing unanticipated adverse Product 
effects shall be provided promptly to the study sponsor. 
 
 
Withdrawal of IRB approval 
An investigator shall report to the sponsor a withdrawal of approval by the investigator’s 
reviewing IRB as soon as possible, but no later than 5 working days from the IRB 
notification of withdrawal of approval. 

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11.3.2 Investigator reporting: Notifying the IRB 
This study will be submitted for review by a central IRB.  Reporting of any reportable 
events will conform to IRB policy and procedures 
 
Adverse Product Effects 
All unanticipated Product effects, and all adverse Product effects resulting in research 
subject death or injury reported by the investigator to the study Sponsor must also be 
reported to the investigator’s local IRB in accordance with their reporting requirements, 
though no later than 10 working days. 
 
Protocol Deviations 
Any protocol deviations initiated without Sponsor and/or the investigator’s IRB approval 
that may affect the scientific soundness of the study, or affect the rights, safety, or 
welfare of study subjects, must be reported to the Sponsor and to the investigator’s IRB 
as soon as a possible, but no later than 5 working days of the protocol deviation. 
 
Reporting Process 
Report unanticipated problems as defined above to the IRB using the form: as indicated 
on the IRB web site/portal or as a written report of the event (including a description of 
the event with information regarding its fulfillment of the above criteria, follow-
up/resolution and need for revision to consent form and/or other study documentation). 
 
Copies of each report and documentation of IRB notification and receipt will be kept in 
the Clinical Investigator’s study file. 
 
12 Receiving, Storage, Dispensing and Return 
12.1 Packaging 
A "fitting kit" consisting of a full set of BONGO devices with the R1 resistor will be 
available to study staff for sizing and acclimation purposes.  These devices will be 
cleaned according to standard practice for cleaning CPAP masks following the facility 
procedures.  Devices will be cleaned after each subject.   
 
For each subject, BONGO nasal inserts of their selected size with both resistors values 
(R1 and R2) will be provided.  If R2 is needed, the sleep technologist will replace the 
Bongo R1 device with the Bongo R2 device. 
12.2 Receipt of Study Product 
Sites will receive and log in all investigational products according to routine practices.  
Devices will be shipped with appropriate labeling and shipped from InnoMed.  
12.3 Dispensing of Study Product 
Product will be dispensed only to those subjects qualified to receive them.  A device 
distribution log will be maintained at the site. 

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12.4 Return of Study Product 
Used devices shall be re-inserted into their original packaging and returned to InnoMed 
at the completion of the study and documented on the appropriate logs.  
13 Data Handling and Record Keeping 
13.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Protected Health Information (PHI) collected during this study is related 
to general health and sleep.  No additional information will be collected regarding the 
subject's PHI.   
Review of data will be allocated to study personnel on a “need to know” basis.  An 
enrolled subject will be assigned a unique patient ID number. Study personnel will use 
the patient ID number to identify all subject data on case report forms.  
In the event that a subject revokes authorization to collect or use PHI, the investigator, 
by regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use 
PHI, attempts should be made to obtain permission to collect at least vital status at the 
end of their scheduled study period. 
13.2 Source Documents 
Source documents may include the following 
• Investigator/Designee Note form 
• Case report forms 
• Data from the CPAP downloads 
• Data from the Polysomnogram 
• Self-completed questionnaires 
13.3 Case Report Forms 
All case report forms (CRF) will be completed in their entirety (i.e. each field filled out 
and or noted as not applicable). For any errors, standard good clinical practice includes 
the following: Each error will be crossed out with a single line, dated and initialed by the 
person who made the correction.  Queries by the monitor will be generated for forms not 
completed and/or illegible 
13.4 Records Retention 
Records will be kept at the investigational research site for a period of no less than 2 
years.  Data will be kept in a secure and locked environment.  It is acceptable to 
maintain records at an off-site facility which can be accessed within a reasonable period 
of time (i.e. 2 days after request).    

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14 Study Monitoring, Auditing, and Inspecting 
14.1 Study Quality/Monitoring Plan 
A study start-up meeting will be conducted to ensure all study staff are informed 
regarding conduct of the study and trained on the investigational product and any 
additional study tasks or procedures that are unique to the study. A study manual of 
operations (MOP) will be provided to the site to enhance GCP of the site.   
 
It is anticipated that this study will be monitored at least once during the course of the 
study, most likely at the end of the study for all subjects enrolled.  However, periodic 
monitoring may be conducted if deemed necessary.  
14.2 Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
the sponsor, government regulatory bodies, and compliance and quality assurance 
groups of all study related documents (e.g. source documents, regulatory documents, 
data collection instruments, study data, etc.).  The investigator will ensure the capability 
for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection 
by government regulatory authorities and applicable compliance and quality assurance 
offices. 
15 Ethical and Regulatory Considerations 
This study falls under the abbreviated requirements for a non-significant risk study 
(NSR, 21 CFR Part 812).  As such this study will be conducted in compliance with the 
requirements of same. This study is to be conducted according to US regulations and 
international standards for Good Clinical Practice, including 21 CFR Parts 50, 54, 56 
and the International Conference on Harmonization guidelines (E-6) and ISO 14155 as 
applicable. In addition institutional research policies and procedures deemed necessary 
to conduct this research. 
 
This protocol and any amendments will be submitted to a properly constituted 
independent Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator and a 
copy of this decision will be provided to the sponsor before commencement of this 
study.  The investigator should provide the sponsor with a list of IRB members and their 
affiliates. 
 
All subjects for this study will be provided a consent form describing this study and will 
be provided sufficient information to make an informed decision about their participation 
in this study. For sites located in California, the Experimental Subject’s Bill of Rights will 
also be provided.  

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See the accompanying copy of the Subject Informed Consent Form.  This consent form 
will be submitted with the protocol for review and approval by the IRB for this study.  
The formal consent of a subject, using the IRB-approved consent form, will be obtained 
prior to that subject undergoing any study procedure.  The consent form must be signed 
by the subject and by the investigator or designee obtaining the consent.  
16 Study Finances 
16.1 Funding Source 
This study is being funded by InnoMed Healthscience 
16.2 Conflict of Interest 
In accordance with good clinical practices, the principal investigator and/or staff will 
provide a signed conflict of interest statement which will include any financial 
relationship with the sponsor. 
16.3 Subject Stipends or Payments 
Subjects will be given a stipend for their participation 
17 
Publication Plan 
The data from this study may be used for publication.  If publication is sought, normal 
precautions with regards to subject confidentiality and privacy will be maintained.  

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18 References 
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