In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Phase: NA
Conditions: Snoring
Sponsor: Philips Respironics

 
 
 
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In Home Assessment of Three Anti-Snoring Devices, a cross over study 
 
 
Clinical Protocol 
 
Protocol# SRC-AI-SilentNight-10090 
 
Version 3.0 
11/14/2017 
 
 
Sponsored by 
 
 
Respironics, Inc., a Philips company ("Philips Respironics")  
1740 Golden Mile Highway 
Monroeville, PA 15146 
USA 
 
 
 
 
Approved By:___________________________________________________________ 
Noah Papas  
 
 
 
 
 
 
Date  
Clinical Development Scientist, Clinical Study Manager 
 
 
 
 
Approved By:___________________________________________________________ 
Jeff Jasko 
 
 
 
 
 
 
 
Date  
Clinical Data Manager, Q&R Reg. & Clin. Aff. - Biostatistics/DM 
 

 
 
 
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TABLE OF CONTENTS 
 
I. 
DOCUMENT CONTROL PAGE ............................................................................... 4 
Participating Study Sites .............................................................................................. 4 
Study Monitor(s)........................................................................................................... 4 
PROTOCOL REVISIONS ................................................................................................ 6 
RESPIRONICS, INC. CONTACT INFORMATION .......................................................... 7 
Technical Assistance ................................................................................................... 7 
Reporting of Adverse Events or Adverse Device Effects ............................................. 7 
II. 
GLOSSARY OF DEFINITIONS AND TERMS ......................................................... 8 
III. BACKGROUND AND SIGNIFICANCE .................................................................... 9 
A. 
Clinical Significance: ............................................................................................. 9 
B. 
Description of Intervention Studied: .................................................................... 11 
1. 
Mute nasal device (RhinoMed, Richmond, Victoria 3121, Australia) ............. 12 
2. 
myTAP™ V (Airway Management, Carrollton, TX) ....................................... 12 
3. 
Sleep Positional Trainer (SPT) (NightBalance, Delft, Netherlands)............... 13 
4. 
Philips SilentNight Mobile Application ........................................................... 13 
IV. STUDY PURPOSE AND OBJECTIVES ................................................................ 14 
A. 
Purpose .............................................................................................................. 14 
B. 
Primary Aim ........................................................................................................ 15 
C. Secondary Aims .................................................................................................. 15 
V. 
STUDY DESIGN AND METHODS ......................................................................... 15 
A. 
Design ................................................................................................................ 15 
B. 
Study Design Rationale ...................................................................................... 15 
C. Study Participants ............................................................................................... 16 
D. Inclusion Criteria (Snorer): .................................................................................. 16 
E. 
Exclusion Criteria (Snorer): ................................................................................. 17 
F. 
Inclusion Criteria (Bed Partner): .......................................................................... 18 
G. Exclusion Criteria (Bed Partner): ........................................................................ 18 
H. Study Procedures and Measurements: ............................................................... 19 
1. 
Study Flowchart ............................................................................................ 19 
2. 
Telephone Screening .................................................................................... 19 
3. 
Visit 1, Intake interview, baseline questionnaires: ......................................... 20 
4. 
Baseline Nights (3 nights) ............................................................................. 20 
5. 
Phone Call 1 ................................................................................................. 21 
6. 
Intervention Nights Set 1 (Mute) ~ 1 week .................................................... 21 

 
 
 
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7. 
Phone Call 2 1st cross over ........................................................................... 21 
8. 
Intervention Nights Set 2 (myTAP V) ~ 2 weeks ........................................... 22 
9. 
Visit 2 2nd cross over .................................................................................... 22 
10. 
Intervention Nights Set 3 (SPT)..................................................................... 23 
11. 
Visit 3 Exit interview ...................................................................................... 24 
12. 
Marketing continuation .................................................................................. 24 
13. 
Table 1: Study Procedures ............................................................................ 25 
I. 
Participant compensation ................................................................................... 25 
VI. STATISTICAL ANALYSIS ..................................................................................... 26 
A. 
Determination of Sample Size ............................................................................ 26 
B. 
General Considerations ...................................................................................... 26 
C. Subject Disposition ............................................................................................. 26 
D. Demographics and Baseline Characteristics ...................................................... 26 
E. 
Primary Efficacy Analysis.................................................................................... 26 
F. 
Secondary Analysis ............................................................................................ 27 
G. Phenotyping exercise (Baseline characteristics, audio file analysis) .................. 27 
H. Study Termination Criteria .................................................................................. 27 
I. 
Safety Analysis ................................................................................................... 27 
J. 
Interim Analysis .................................................................................................. 28 
VII. PROTECTION FOR HUMAN PARTICIPANTS...................................................... 28 
A. 
Potential risks and discomforts ........................................................................... 28 
B. 
Potential Benefits ................................................................................................ 29 
C. Confidentiality ..................................................................................................... 29 
D. Provisions to Protect the Privacy Interests of Participants .................................. 30 
E. 
Compensation for Research-Related Injury ........................................................ 30 
F. 
Vulnerable Populations ....................................................................................... 30 
G. Community-Based Participatory Research ......................................................... 30 
H. Sharing of Results with Participants ................................................................... 30 
I. 
Economic Burden to Participants ........................................................................ 30 
J. 
Withdrawal Criteria ............................................................................................. 30 
VIII. MONITORING AND QUALITY ASSURANCE ....................................................... 31 
IX. REGISTRATION ON CLINICALTRIALS.GOV ...................................................... 32 
X. 
REFERENCES ....................................................................................................... 33 
XI. 34 
XII. APPENDICES ........................................................................................................ 35 
 

 
 
 
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I. 
DOCUMENT CONTROL PAGE 
 
Protocol Title: In Home Assessment of Three Anti-Snoring Devices, a cross over study 
 
Protocol Number: SRC-AI-SilentNight-10090  
 
Protocol Version: 3.0 
 
Version Date: 11/14/17 
 
Author(s):  Noah Papas 
 
 
 
Participating Study Sites 
Study Site:   
 
Philips Respironics  
Principal Investigator:  
David Pollard White, MD 
Site Address:  
 
1010 Murray Ridge Lane 
 
 
 
 
Murrysville, PA 15668 
Telephone:  
 
617-470-8700 
 
 
 
Study Monitor(s) 
 
Noah Papas  
Clinical Development Scientist 
Phone: (724) 387- 4565 
Cell: (412) 277-6436 
Email: noah.papas@philips.com 
 
 

 
 
 
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Investigator Agreement. 
 
As Investigator of the study entitled “In Home Assessment of Three Anti-Snoring 
Devices, a cross over study”, Protocol # SRC-AI-SilentNight-10090, I agree to:  
 
(i) conduct the Study in accordance with: this Investigator Agreement; the Study’s 
Protocol as approved by the IRB (the “Protocol”); Good Clinical Practices, the 
Declaration of Helsinki; all other applicable laws and regulations; and any IRB or FDA 
conditions of approval;   
 
(ii) await IRB approval for the Protocol before obtaining informed consents; 
 
(iii) ensure that all requirements for informed consent are met and not let any subject 
participate in the Study before obtaining that subject’s informed consent;  
 
(iv) not make modifications to the Protocol as supplied to me by Philips Respironics (the 
“Sponsor”), without first obtaining the written approval of the Sponsor;  
 
(v) provide the Sponsor with accurate financial information as required by FDA 
regulations; 
 
(vi) supervise all testing of investigational devices that involves any Study subject;  
 
(vii) maintain Study documentation for the period of time as required by FDA 
regulations;  
 
(viii) will supply to the Sponsor, as part of this Investigator Agreement, my curriculum 
vitae. 
 
 
 
 
 
 
 
Investigator Signature: 
 
 
 
 
 
 
 
 
Printed Name:  
 
 
 
 
 
 
 
 
 
Date:  
 
 
 
 
 
 
 
 
 

 
 
 
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PROTOCOL REVISIONS 
 
Rev 
Level 
 
Changes Made  
 
Date 
 
Contributors 
0.0 
Initial 
September 6, 2017 
N. Papas, B. Shelly, 
D. White M.D. 
1.0 
Addition of Appendix XIII, updated 
Version of myTAP device, Change in 
Positional trainer from Pose to SPT, 
increased participant compensation, 
updated Appendix III, updated 
compensation, timing of visit 2 and 3 
updated to reflect IC, provided clarity 
on regulatory  
September 22, 2017 
N. Papas 
2.0 
Various typos, modified exclusion 
criteria, changed visit schedule (Visit 
2 replaced with a phone call, 
Optional combination week removed 
Visit 5 removed), increase 
compensation 
September 26, 2017 
N. Papas 
3.0 
Administrative change, did not 
completely remove all references to 
combination of products in Version 
2.0, see aims section for update 
November 14, 2017 
N. Papas 
 
 
 

 
 
 
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RESPIRONICS, INC. CONTACT INFORMATION 
 
Technical Assistance 
The following Philips Respironics employees are available for consultation, assistance, 
and/or problem solving during the course of this research study: 
 
Kousalya Rondinelli 
Sr. Mobile Applications Developer 
Phone: 412-951-7395 
Email: kousalya.rondinelli@philips.com 
 
Benjamin Shelly 
Sr. Systems Research Engineer 
Phone: 724 387-4816 
Email: Benjamin.Shelly@philips.com 
 
Reporting of Adverse Events or Adverse Device Effects 
Report the occurrence of an adverse event or adverse device effect to Philips 
Respironics within 24 hours of the occurrence. 
 
Noah Papas 
Clinical Project Manager 
Phone: (724) 387-4565 
Email: noah.papas@philips.com 
 
 
Gary Lotz 
Director, Clinical Research 
Phone: (724) 733-5812 
E-mail: gary.lotz@philips.com 
  
 
 

 
 
 
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II. 
Glossary of Definitions and Terms 
 
 
Obstructive Sleep Apnea (OSA): a disorder in which the airway collapses, either 
completely or partially, repeatedly during the night and is associated with oxygen 
desaturation, sleep fragmentation, and daytime sleepiness.  
 
Snoring: a snorting or grunting sound in a person's breathing while asleep (Oxford 
Dictionary)  
 
AHI: an index used to indicate the severity of sleep apnea. It is represented by the 
number of apnea and hypopnea events per hour of sleep. The hypopneas (pauses in 
breathing) must last for at least 10 seconds and be associated with a decrease in blood 
oxygenation or an arousal from sleep. 
 
CPAP: Continuous positive airway pressure, colloquially often used to refer to a 
machine which uses an increase of air pressure to keep an airway open in someone 
who has OSA 
 
EDC: Electronic Data Capture, a system to record clinical data in an electronic manner 
and which is auditable. 
 
HIPAA: Health Insurance Portability and Accountability Act of 1996, a US legislation 
that provides data privacy and security requirements for safeguarding medical 
information. 
 
 
 

 
 
 
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III. 
BACKGROUND AND SIGNIFICANCE 
A. Clinical Significance: 
Snoring is defined as a coarse, harsh sound caused by the vibration of soft tissue in the 
upper airways involving anatomical structures such as the soft palate, uvula, and tongue 
base. Habitual snoring is common, but prevalence varies widely 15-54% ([1-5]). In looking 
at differences in sex, 44% of men snore and 28% of women snore [5].  Common 
correlations with snoring include age, being overweight, nasal and sinus problems, 
alcohol intake, smoking, certain medications, and sleep position.  
 
Snoring is a common sign of obstructive sleep apnea (OSA); however many cases of 
snoring are unrelated to OSA.  This is known as simple or primary snoring. If one removes 
those who have an Apnea Hypopnea Index (AHI) greater than five, prevalence of primary 
snoring is approximately 42% in both men and women [5] (calculated from Table 3 of 
reference). In these cases, the sleep of the primary snorer is less likely affected, thereby 
leaving their bed partner to contend with the loud sounds. Bed partners of snorers 
frequently suffer from poor sleep quality and even possible hearing loss due to the 
disturbance [6]. Furthermore, this poor sleep quality leads to excessive daytime 
sleepiness which interferes with daily life [5]. 
 
The biomechanics of snoring is interesting; from a theoretical perspective it can be 
modeled as “coupled oscillation of the walls of the airway with airflow through it” [1]. 
Specifically, snoring occurs when airflow becomes unstable over a flexible structure.  
Anatomically, there are a few places where the sound can originate, most notably the 
pharynx, and soft palate (tonsil, velar, tongue) [1, 3, 7].  These locations can have 
different acoustic signatures [3, 7] and may require different solutions to resolve. 
 
Due to the multiple etiologies of a snore, many anti-snoring solutions exist.  They 
include (but are not limited to) oropharyngeal exercises [8], pharmacologic solutions [9], 
nasal dilators [10-14], positional trainers [15, 16], and mandibular advancement (also 

 
 
 
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known as oral appliances) [16-20]. Even CPAP has been used to treat primary snoring 
[21].   
 
Primary snoring itself is not considered a medical condition per say, thus these 
solutions are not always considered medical devices.  Hence, concerned snorers may 
or may not be dealing with the condition under council of a physician and would not 
necessarily know what the source of the snoring is.  Therefore concerned snorers often 
blindly use a “trial and error” approach to select an anti-snoring solution. This method is 
often expensive, time consuming, and unsuccessful [22].   
 
A previous clinical study conducted at Philips, CAI-16023-SNOPIL-KD, attempted to 
systematically move participants through a decision tree (Philips study algorithm) and 
understand the sleep disturbance of bed partners who use the anti-snoring solutions 
recommended by the decision tree.  The study algorithm would recommend one of 
three snoring solutions (Mute, myTAP, Pose [analogous to SPT]) based upon a three 
question questionnaire. Then, based upon usage and perceived snoring reduction, 
combinations of products would be recommended at subsequent visits.  It was 
hypothesized that 60% of the couples in the study would see a measurable reduction in 
partner’s sleep disturbance.   
 
For the study, 33 couples were enrolled, 32 couples finished the study.  The bed 
partners’ average sleep disturbance due to snoring (the primary outcome from this trial) 
went from 7.6, on a 0-10 scale, to a 2.8 at study’s end.  Further, 72% of bed partners 
agreed that the trial reduced their partner’s snoring, but only 42% felt it stopped the 
snoring completely.  However, to achieve this outcome, the study algorithm took 5 
weeks and 64% of snorers ended up on a device combination of the two most 
expensive snoring solutions [23].  Finally, this trial and market research rejected the 
business model proposed by the trial’s Philips study algorithm.  Consumers favor an 
approach that “gets its right the first time” and may be willing to pay for a personalized 

 
 
 
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recommendation on anti-snoring solution if their/bed partner’s snoring is reduced by 
50% [22]. 
 
Therefore, in order to help the concerned snorer find a solution, more data must be 
gathered.  There is a need to assess the same three interventions (Mute, myTAP, and 
Sleep Position Trainer [SPT] [see section III.B.]) in order to understand how well each 
intervention works in a specific individual.  Then, there is a hope to cluster the 
individuals based upon intervention success to understand what questions can be 
asked a priori that would predict an intervention’s success.  Thus, there is a hope to 
redesign the intake questionnaire for the SilentNight app, ensuring that the right product 
is recommended from the start and a “trial and error” approach (as the prior study 
algorithm used) is not needed. 
 
Lastly, there is also a desire to develop an audio detection of snoring to create a “snore 
score,” a numerical representation of how someone snored during the night.  It is also in 
the development pipeline to use audio to more accurately phenotype an individual’s 
problem.  Prior studies have looked at audio of snoring both in a lab setting [24-26] and 
while patients were in drug induced sleep [7, 27].  For example, it has been shown that 
tongue based snoring has a frequency above 500 Hz. whereas palatial snoring is below 
500 Hz.  However, little “in the wild” data exists.  So, while it may be theoretically 
possible to phenotype a snore based upon audio, it is still unknown if it is practical to 
phenotype a snore using audio recorded in a user’s bedroom. 
 
B. Description of Intervention Studied:  
We will use three different anti-snoring devices which target different sources of 
snoring. All study devices are single patient use. One is currently marketed in the US 
while the other two are investigational.  In addition, we will use an audio recording 
device to record room sounds for product development of a snore detection app. 
 

 
 
 
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1. 
Mute nasal device (RhinoMed, Richmond, Victoria 3121, Australia)  
Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the 
nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product 
and is cleared by FDA for use in the United States. The introduction video for Mute is 
located at http://mutesnoring.com/how-to-use/. 
 
Nasal dilators have been used to treat snoring and sleep apnea [10-13].  Many studies 
focus on external nasal dilators like Breathe Right Strips.  These interventions largely 
were not effective in treating OSA [10].  However, there is some evidence to suggest 
internal to the nose dilators (like Mute) may work to reduce snoring.  A small study 
(n=11) using Nozovent, showed that there was substantial decreasing in snoring noise 
in all patients studied [13].  Also a white paper from RhinoMed claims that 73% of bed 
partners reported a reduction in snoring severity [28]. 
 
2. 
myTAP™ V (Airway Management, Carrollton, TX)  
For purposes of this trial, we will be using an investigational myTAP V, which is not 
available for commercial use.  The changes from the released product are: a vertical 
offset (+3mm) has been added to the design of the adjustment post and mechanism to 
improve overall comfort. 
 
myTAPTM is a mandibular advancement device used for snoring relief. The product 
requires a prescription and is cleared by FDA for use in the United States. The 
introduction video for myTAP™ is located at 
https://www.youtube.com/watch?v=ehVZf1b2wi0.   
 
Mandibular advancement devices have shown to be effective, but not necessarily 
acceptable to primary snorers [16-20]. 
 

 
 
 
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3. 
Sleep Positional Trainer (SPT) (NightBalance, Delft, 
Netherlands)  
Sleep Positional Trainer (SPT) is a small device worn around the chest with an 
ergonomic band that continuously monitors the sleep position of the snorer. When the 
snorer is supine, it emits a gentle vibration to remind them to turn to the side to help 
reduce or eliminate their snoring.  It is not available in the United States and therefore is 
considered investigational use as part of this study. Though this product is available in 
various European countries including Austria, Belgium, Denmark, France, Ireland, The 
Netherlands, Norway, Sweden, and Switzerland.  The instruction video for NightBalance 
SPT is located at http://www.nightbalance.com/product-support/.   
 
Studies have shown mixed results for positional therapy as a whole [15].  Braver and 
Block reported that foam wedges used to keep patients in a lateral position were not 
effective in reducing snoring in 20 individuals [29].  But Choi et al successfully treated 
17 individuals with an inflatable vest reducing snoring rate from 36.7% to 15.7% [30].  In 
a far more extensive study of OSA patents, Benoist et al tested a NightBalance product 
specifically [16].  In a sample of 81 individuals they found that positional therapy with 
the NightBalance product reduced AHI in an OSA population from 13.0 to 7.0, which 
was just as effective as an oral appliance.  Also, adherence to positional therapy was 
almost 90%. Therefore, it can be hypothesized that the SPT will also be effective for 
positional primary snoring. 
 
4. 
Philips SilentNight Mobile Application 
Philips SilentNight application is an audio recording application for the collection of 
snoring sounds. It may also be used to collect questionnaire data. The app complies 
with applicable privacy and security standards for clinical research activities. The app’s 
functionality is limited and data will be contained on the phone. At each visit in the trial, 
data will be removed from the phone by a member of Philips staff.  Wire frame of the 
app is shown in Appendix I. 

 
 
 
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During the trial, the snorer will be asked to use a provided Android-based device with 
the app installed to record themselves sleeping each night. Snorers will be instructed to 
use the app to collect recordings daily. Although the app is intended to collect snoring 
sounds, all room sounds will be recorded each night. The snoring sounds will be 
extracted from the recordings at a later time for further product development of a snore 
detection app. Permission to record all room sounds will be obtained from both the 
snorer and bed partner during consenting. 
 
IV. 
STUDY PURPOSE AND OBJECTIVES 
 
A. 
Purpose 
The purpose of this trial is twofold. Firstly, while each of the interventions to be studied 
are known to be effective for snoring cessation, each is not fully effective in the total 
population. Each intervention’s efficacy on a given individual is predicated by an 
individual’s physiology and their contributing factors to their snoring.  In order to improve 
the SilentNight recommendation algorithm, more information needs to be gathered.  By 
asking a battery of questions of a snorer and having them trial all three snoring 
solutions, it may be possible to understand the comparative effectiveness of each 
solution, the user acceptance of each solution, and which questions should be used to 
discern an acceptable and effective solution for a given individual. 
 
Secondly, it is a long-term development goal of the SilentNight program to use audio 
analysis of a snore in order to make product recommendations.  This protocol is 
designed to collect “in the wild” audio of snoring.  The goal of this data collection is to 
identify unique characteristics in the sound recording. These, paired with the answers to 
the intake questions and the relative effectiveness of the three anti-snoring solutions 
could phenotype the snore and snorer.  This audio data could also be used to develop 

 
 
 
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or refine a “snore score”, a semi-objective assessment of snoring audio which can be 
calculated daily. 
 
B. Primary Aim 
Understand the comparative effectiveness of three different anti-snoring solutions and 
determine which is/are the correct solution for a given individual. 
 
We expect there to be a different effectiveness of each of the three anti-snoring 
solutions over the entire population studied.  However, there is no hypothesis as to 
which will be most effective.  Rather it is a goal to understand what the best solution is 
for a given individual, and generalize this finding to a larger population. 
 
C. Secondary Aims 
1. Understand user acceptance of each solution. 
2. Collect audio data of snoring in different individuals in a baseline setting 
and using various anti-snoring solutions. 
 
All secondary aims are information gathering.  There is no hypothesis to test. 
 
V. 
STUDY DESIGN AND METHODS 
 
A. Design  
 
This is an open-label crossover, comparative effectiveness trial.  
 
B. Study Design Rationale 
 
This is a pilot study.  As each participant will serve as their own control, our 
enrollment size can be kept small.  Thus, this is a feasibility study utilizing a small 
number of patients.  No previous data exist for power calculations. The results 
may also provide statistical justification for later studies.  Also, being a pilot, there 
are no procedures taken to avoid bias, such as randomization or blinding.  This is 

 
 
 
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a limitation of the study as we will not be able to separate the device effect from 
any possible order effect. 
 
C. Study Participants 
 
We anticipate enrolling up to 30 couples to have 25 completing the study. We will 
attempt to study an equal number of men and women.  Participants will be 
enrolled in the study for up to 40 days. 
 
Potential participants will be recruited by an external to Philips marketing firm 
(Campos Inc., Pittsburgh, PA), either from their existing database, word of 
mouth, or through media advertisements (e.g. Craigslist, local newspapers, 
flyers, targeted Facebook advertisements, institutional postings).  These ads will 
be used to identify participants with a history of snoring and their troubled 
bedpartner. Participants at high risk for sleep apnea will be excluded from the 
study, as determined by the Snore Scale Score [31] and OSA50 [32] 
questionnaires (Appendix II) identified through a phone screening (Appendix III). 
 
D. Inclusion Criteria (Snorer): 
 
• Adults aged 21 to 55 
• Able and willing to provide written informed consent 
• Able to read and understand English 
• History of snoring for more than 6 months (by self-report). 
• Sleep with a bed partner for at least 4 nights per week (by self-report). 
• Told by bed partner that snoring frequently disturbs his or her sleep (by self-
report). 
• Have seen a dentist within 12 months (by self-report). 
• Willing to not use any anti-snoring aids that are not associated with the study (by 
self-report). 

 
 
 
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• Has purchased  or used or bed partner has purchased an anti-snoring product in 
the past (by self-report) [These individuals may be included in the study if 
recruitment timeline dictates it] 
 
E. Exclusion Criteria (Snorer):  
 
• Scored higher than a 9 on the Modified Snore Scale Score (MSSS>9) 
• Scored higher than a 6 on the OSA 50 screener (OSA50>6) 
• The presence of physical or mental limitations that would limit the ability to use 
the anti-snoring solutions. 
• Any unstable medical condition like congestive heart failure, neuromuscular 
disease, renal failure, or cancer (as determined by self-report and reviewed by 
the study PI). 
• Any severe respiratory condition (like an exacerbation of Chronic Obstructive 
Pulmonary Disease, bronchitis, sinusitis, respiratory failure or insufficiency or 
patients requiring oxygen therapy). 
• Known history of Obstructive Sleep Apnea (OSA) or Central Sleep Apnea 
Syndrome (by self-report) 
• Only able to sleep in the supine (flat on one’s back) position (by self-report).  
• Actively suffering from an upper respiratory infection (by self-report).  
• Have a planned medical or dental procedure involving the head, neck, face 
(eyes, ears, nose, teeth, mouth), or lungs during the trial period (by self-report). 
• Under active treatment for an active dental problem by a dentist or orthodontist  
• Have one or more of the following dental issues (by self-report) 
o Removable dentures or bridges. 
o Temporary crowns, loose teeth, loose crowns, loose fillings, or broken teeth 
o Less than 8 natural, healthy teeth in each dental arch (upper and lower teeth) 
o Dental braces 
o TMJ issues 

 
 
 
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F. Inclusion Criteria (Bed Partner): 
• Adults aged 21 to 70 
• Able and willing to provide written informed consent 
• Able to read and understand English 
• Rates sleep disturbance caused by partner’s snoring greater than or equal to 4 
on a scale of 1-10 
• Rates level of snoring volume greater than or equal to 7 on a scale of 1-10 
• Willing to sleep in same room as snorer during the study period (by self –report).  
• Willing to not start any new over-the-counter or prescription sleep medication 
including sedatives and hypnotics during the study period (by self-report).  
 
G. Exclusion Criteria (Bed Partner): 
• Told by bed partner that their snoring frequently disturbs his or her sleep (by self-
report). 

 
 
 
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H. Study Procedures and Measurements:  
1. Study Flowchart 
 
 
2. Telephone Screening 
As stated in section V. C. Study participants, an outside marketing firm will be 
conducting recruitment and doing an initial phone screening.  The script of the phone 
screen is attached as Appendix III, and involves screening out participants for OSA.  
For this purpose the OSA50 and MSSS questionnaires will be used (Appendix II). 
 
Legend 
Market Firm 
Participant 
Philips/Participant 
Recruitment 
(Marketing 
firm) 
Exclude 
Is the participant 
eligible? 
Y 
N 
Exclude 
Does the 
participant 
Consent? Still 
eligible? 
Y 
N 
Visit 1 
Consent 
Review Eligibility 
Criteria 
Demographics 
Anthropomorphic  
Measurements 
Medical History 
Baseline 
3 days 
In app Sleep 
Diary/Bedpartner 
question 
In app record of 
snoring 
Visit 1  
STOP BANG 
Intake interview  
Phenotyping 
Questionnaires 
Distribution of 
equipment 
(phone/mute) 
Phone Call 2 
(Crossover 1) 
Impression 
interview  
Ship myTAP device 
myTAP 
~ 2 weeks 
In app Sleep 
Diary/Bedpartner 
question  
In app record of 
snoring 
Visit 2 (Crossover 2) 
Impression interview  
myTAP V and Mute 
Fit assessment 
 
Trade out devices 
Data Download 
Visit 4 
Impression 
interview 
Final Study 
Interview 
SPT 
~2 weeks 
Sleep Diary 
Bedpartner 
question 
In app record of 
snoring 
Study 
End 
Mute 
~1 week 
In app Sleep 
Diary/Bedpartner 
question 
In app record of 
snoring 
Phone call 1 
(Reminder) 

 
 
 
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3. Visit 1, Intake interview, baseline questionnaires: 
 
The recruited couple will be asked to come to the Philips facility, or other 3rd party 
location (Campos, or nearby hotel meeting room).  After both participants are consented 
to the study procedure, eligibility will be reviewed, including an OSA screening 
questionnaire (snorer only).  Demographic data will be collected. The snorer will have a 
baseline assessment including, STOP-BANG (Appendix XIV), medical history, a review 
of current medications, anthropometric measurements (height, weight, neck 
circumference), and BMI.  A phenotyping questionnaire about snoring and sleep will be 
completed by the snorer (Appendix IV). The couple will be interviewed by the Philips 
researchers using a semi structured interview style (Appendix V and Appendix VI). 
These interviews may be audio recorded (with participant consent), and stored for up to 
6 months on a secure server. These interviews will be in person. 
 
Next, participants will be given a phone with the SilentNight app preloaded.  They will 
be shown how to use the application and reminded to record their snoring every night 
and answer the questionnaire every morning. During the trial period, the bed partner is 
instructed to sleep in the same room with the snorer in order to provide feedback about 
their sleep. 
 
Finally, they will be given a “trial pack” of the Mute devices.  Instructions for use for the 
Mute device will be reviewed, and study procedures will be reiterated (app usage, 
nightly recording and morning questions).  The entire visit will take approximately 1 
hour. 
 
4. Baseline Nights (3 nights) 
 
Participants will record three nights of baseline snoring. No intervention will be used on 
these nights.  In the morning, both the snorer and bed partner will fill out the daily 
questionnaire (Appendix VII) in the app on the mobile device. 

 
 
 
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5. Phone Call 1  
 
On day three of the study, participants will be contacted by Philips, reminding them to 
start using the Mute.  The Philips team will check in to see if there are any issues with 
the app, and they will also remind them of the upcoming visits to the Philips designated 
facility. 
 
6. Intervention Nights Set 1 (Mute) ~ 1 week 
 
Snorers will be asked to wear the Mute device for one week. 
 
If they have any concern over the use of the Mute device, or note any significant 
discomfort they are to stop its use and call Philips. 
 
During this week, the bed partner will be instructed to sleep in the same room as the 
snorer.  Participants will record room noise during the night. In the morning both the 
snorer and bed partner will fill out the daily questionnaire on the phone. 
 
7. Phone Call 2 1st cross over 
Approximately 1-2 weeks after the initial visit participants will be called 30 min interview.   
 
The snorer and bedpartner will be interviewed separately again using the guided 
interview technique.  They will be asked questions regarding the use of the Mute 
device, their perception of snoring, and sleep quality. The interviews will follow a script 
attached as appendices VIII and IX.  These interviews may be audio recorded (with 
participant consent), and stored for up to 6 months. 
 
Finally, they will be sent the myTAP V product, and a set of instructions.  They will be 
asked to view the video on how to fit the myTAP which is included in the consent form.  
They will also be sent a questionnaire specific to the myTAP V fitting, which they will 

 
 
 
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need to complete partly just after fitting, and partly after the approximately 2 weeks of 
use. 
 
8. Intervention Nights Set 2 (myTAP V) ~ 2 weeks  
 
Prior to the set of intervention nights, the snorer will follow the instructions and fit the 
myTAP V device themselves using the “boil and bite” technique (See Appendix X for 
more information).  After fitting they will need to complete Q1 of the myTAP V 
questionnaire (Appendix XIII).  They will utilize the device at night.  They will have the 
opportunity to titrate the mandibular advancement per the study instructions for use 
(Appendix X), in order to gradually get used to the device, and potentially improve 
effectiveness.  At the end of their myTAP V use, they will complete the remainder of 
Appendix XIII. 
 
If they have any concern over use of the myTAP V device, or note any discomfort they 
are to stop its use and call Philips.  They may be instructed to discontinue the use of 
myTAP V all together, or make some adjustments.  All will be at discretion of the PI. 
 
Regardless of device usage, the bed partner will be instructed to sleep in the same 
room as the snorer.  Participants will record room noise during the night. In the morning 
both the snorer and bed partner will fill out the daily questionnaire on the phone. 
 
9. Visit 2 2nd cross over 
 
Approximately 2-3 weeks after Phone Call 2 (1st crossover) and 3-4 weeks after the 
initial visit 1, participants will return for an approximately 30 min visit.  They will bring 
both the myTAP V device and mobile device with the SilentNight application.  Data from 
the mobile device will be downloaded off of the phone.  A grouping standardized picture 
of the myTAP V device will be taken and the investigational device returned to Philips. 
 

 
 
 
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Participants will report what size of Mute device they used for the week of use.  They 
then will be assessed using the Mute online snoring guide (https://mutesnoring.com/wp-
content/uploads/2016/11/Mute_online_sizing_guide2.pdf), in order to confirm they used 
the proper size. 
 
Next, the snorer and bedpartner will be interviewed separately, again using the guided 
interview technique.  They will be asked questions regarding the use of the myTAP V 
device, their perception of snoring, and sleep quality.  The interviews will follow a script 
attached as appendices VIII and IX.  These interviews may be audio recorded (with 
participant consent), and stored for up to 6 months.  The bed partner interview may be 
conducted over the phone. 
 
Finally, they will be given sizing information for the SPT device and will choose a size.  
Instructions for use for the SPT device will be reviewed, and study procedures will be 
reiterated (app usage, nightly recording and morning questions). 
 
10. Intervention Nights Set 3 (SPT) 
Snorers will be asked to wear the SPT device for two weeks.  The first few nights will be 
the normal calibration period with the device, and the second week will be full sleep 
training mode.  The titration of the device will be as follows: 
 
Figure 2: SPT Titration program, taken from the SPT Device Manual 
 

 
 
 
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If they have any concern over the use of the SPT device, or note any discomfort they 
are to stop its use and call Philips. 
 
During these two weeks, the bed partner will be instructed to sleep in the same room as 
the snorer.  Participants will record room noise during the night. In the morning both the 
snorer and bed partner will fill out the daily questionnaire on the phone. 
 
11. Visit 3 Exit interview   
Approximately 5-6 weeks after the initial visit (~2 weeks after visit 3) participants will 
return for an approximately 1 hour visit.  They will bring the mobile device with the 
SilentNight application.  Data from the mobile device will be downloaded off of the 
phone. 
 
Next, the snorer and bedpartner will be interviewed separately again using the guided 
interview technique.  They will be asked questions regarding the use of the SPT device, 
their perception of snoring and sleep quality. The interviews will follow a script attached 
as appendices VIII and IX.  These interviews may be audio recorded (with participant 
consent), and stored for up to 6 months.  These interviews will be in person. 
 
A final exit interview will be conducted, see appendices XI and XII for details.  Like all 
other interviews, it may be audio recorded and the recording will be kept on file for 6 
months. Most of the investigational materials (mobile device and SPT) from the study 
will be collected.  The participant may dispose of the Mute device if they desire.  Data 
from the SPT device may be downloaded, by either Philips or NightBalance. 
 
12. Marketing continuation  
 
After the exit interview, we will ask participants their permission for Philips to follow up 
with them at any time in the 3 months following the study’s end.  This will be a purely 
marketing effort.  As such, after Visit 5 participants will be considered exited, and 
adverse events will no longer be tracked.  The follow up will be useful after the data 

 
 
 
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analysis has begun, thus questions are not known at this time.  Participants that agree 
to be contacted will initial an acknowledgement of participation at the time of consent, 
and will be entered into a drawing to win an additional $50 gift card. 
 
13. Table 1: Study Procedures  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I. 
Participant compensation 
 
The couples will be compensated for their time in the study as well as incentivized to 
provide data recordings and daily survey answers.  The latter incentive in no way 
reflects their use of any of the products in the study, participants can stop their use at 
any time.  However, in a prior study CAI-16023-SNOPIL-KD there was issue with 
collection of recordings.  Further couples will still be paid a base of 25 dollars a week 
regardless of recording etc.  Couples may withdraw at any point and compensation will 
be prorated at that time.  In total the enrolled couple could earn up to $1000 dollars.  
The payment schedule is as follows: 
 
Visit 1:  
 
 
 
$125  
Procedures 
Visit 1 
Phone 
Call 1 
Phone 
Call 2 
Visit 2 
Visit 3 
Consent  
X 
 
 
 
 
OSA Screening Questionnaires 
X 
 
 
 
 
History & Physical 
X 
 
 
 
 
Anthropometric Measurements 
X 
 
 
 
 
Medication List 
X 
 
 
 
 
Baseline Questionnaire  
X 
 
 
 
 
Baseline Snoring Questionnaire 
X 
 
 
 
 
Distribute Audio Device/App 
w/Training   
X 
 
 
 
 
Mute Instructions 
X 
X 
 
 
 
myTAP V instructions 
 
 
X 
 
 
SPT Instructions 
 
 
 
X 
 
Download Data 
 
 
 
X 
X 
Guided interview 
 
 
X 
X 
X 
Bed partner may be interviewed 
over the phone 
 
 
X 
X 
 
Exit Interview 
 
 
 
 
X 
Collection of Equipment 
 
 
 
 
X  

 
 
 
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Phone Call 2: 
 
 
$50 
Visit 2:  
 
 
 
$75 
Visit 3: 
 
 
 
$100 
In home study enrollment:   
$90 dollars per week of (5 wks for a total of $450). 
Successful audio recording 
$5 (40 nights for a possibility of $200) 
 
VI. 
STATISTICAL ANALYSIS 
A. 
Determination of Sample Size 
Thirty couples may be enrolled in order to ensure 25 completed the data sets.  Since 
this is a pilot study, no sample-size calculation was performed. 
 
B. 
General Considerations  
Descriptive statistics will be presented for all variables of interest.   Continuous data will 
be summarized by mean, standard deviation, median, minimum, and maximum values.  
Categorical data will be presented as frequencies and percentages.  Endpoints will be 
compared between conditions to assess algorithm performance.  Any formal 
significance testing will be performed at p < 0.05. 
 
C. 
Subject Disposition  
Subject disposition, including the total number of participant’s enrolled, completed, early 
terminations and withdrawal will be presented in the analysis. In addition, a listing will 
be provided with the reasons for discontinuation. 
 
D. 
Demographics and Baseline Characteristics 
These data will be collected and summarized with descriptive statistics. 
 
E. 
Primary Efficacy Analysis 
The primary endpoint will be the daily rating of snoring severity as rated by the bed 
partner.  The daily responses will be averaged on a weekly basis.  Due to titration and 
acclimation during the 9 nights of use nights 10-14 of myTAP V and SPT use will be 
compared to the week of Mute use.  If formal statistical comparisons are performed, 
continuous data will be compared between the three therapies using repeated-

 
 
 
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measures ANOVA or the non-parametric Friedman Test, depending on the distributions 
of the endpoints.  If an overall significant effect is observed, post-hoc pairwise tests will 
be done with a suitable adjustment for multiple comparisons.  Categorical data will be 
compared between therapies using the Cochran’s Q test. 
 
Other analysis may be conducted looking at trends, or grouping the full gamut of nights 
for these longer interventions.   
 
F. 
Secondary Analysis 
Also studied will be endpoints such as snorer perception of their sleep and 
Bed partner perception of sleep quality, subjective acceptability of the solutions, etc. 
 
G. 
Phenotyping exercise (Baseline characteristics, audio file analysis) 
A cluster analysis will then be performed on the baseline questionnaire data to 
determine if effective and acceptable snoring solutions can be recommended based on 
simple questionnaire data. Similarly, a cluster analysis will also be performed on the 
baseline audio data in order to determine if effective snoring solutions can be 
recommended based on audio data or audio and questionnaire data. 
 
H. 
Study Termination Criteria 
 
Due to the small sample size, there are no a priori criteria for the termination of the 
study, nor is there a need for sensitivity analysis 
 
I. 
Safety Analysis 
Safety evaluations will be performed by recording clinical adverse events at the time 
originally reported and at each visit thereafter.  Adverse events will be provided in data 
listings. 
A complete medical history will be obtained at screening, and subjects having any of the 
outlined exclusion criteria will be immediately discontinued. 

 
 
 
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J. 
Interim Analysis 
As this is a pilot study, analysis will be completed as desired by the sponsor.  
 
VII. 
PROTECTION FOR HUMAN PARTICIPANTS 
A. 
Potential risks and discomforts 
Overall, risks in this study are minimal. However, the potential risks are detailed below, 
and they will be described in informed consent and will be repeated verbally to the 
participants prior to use of the anti-snoring devices. 
 
The use of positional therapy devices such as SPT may include slight discomfort of the 
ergonomic band that wraps around the chest to keep the trainer in place. If the 
participant experiences pressure from the band, it can be slightly adjusted to increase 
comfort. Participants can also wear the band over common sleepwear to minimize any 
discomfort.  
 
Possible side effects of the myTAPV include: 
• 
Slight tooth or gingival discomfort due to pressure from the appliance. 
• 
Excess salivation initially. This will improve as you become accustomed to wearing the 
myTAP V 
• 
Slight jaw soreness or tightness, initially and with adjustments.  
• 
Temporary bite change. This may subside approximately 30 minutes after the myTAP V is 
taken out of the mouth in the morning.  
• 
Unconsciously taking the myTAPV out of your mouth at night.  
• 
Movement of teeth. 
• 
Pain in the jaw joint. 
• 
Permanent bite change.  
• 
Mouth dryness – the mouth shield accessory can help prevent dryness. 
 
Furthering the risk of the myTAP V product, will be its use in an in home setting, and not 
being fitted by a trained specialist (i.e. dental hygienist, sleep technologist, dentist etc.).  
The product is commonly sold as an over the counter product in other markets, and 
there is a desire to see if this model can work with SilentNight.  Therefore, participants 
will be given instructions and tips and tricks prior to fitting the device themselves. 
 

 
 
 
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The nasal dilators like the Mute may cause nasal irritation and discomfort. Inform the 
participant to discontinue use and contact the study center if irritation occurs. 
 
There are no substantial bodily risks associated with use of the SilentNight app and 
Android phone device. Risks in using the Android phone device is no different than 
those routinely encountered with using other mobile phone devices.  There is a risk that 
the snoring app will collect data not related to the study (secondary data) which may 
include the potential of recording personal and sensitive data. It is recommended that 
this data be deleted and/or not stored with the recording and additionally removed from 
any retention of the recording for other research uses and purposes. 
 
Both participants may experience difficulty sleeping and drowsiness during the study.  
 
 
B. 
Potential Benefits 
There are no direct benefits to participants in this study. It is possible that one or more 
of the interventions will prove to be effective at reducing the snoring disturbance.  It is 
hoped that the results of this study will lead to new treatment strategies for snoring.  
 
C. 
Confidentiality 
Privacy rules and requirements according to governing regulations will be implemented. 
All the information collected as part of this study will be kept confidential. All information 
collected for this study will be kept in a secured area or stored in a password protected 
computer if digital. Except when required by law, participants will not be identified by 
name, social security number, address, telephone number, or any other direct personal 
identifier in study records. For records disclosed outside Respironics, participants will 
be assigned a unique code number.  The key to the code will be kept by the 
investigator. Data will be managed by study number and analyzed anonymously. 
 

 
 
 
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The study results will be retained in the participant’s research record for five years or 
until the study is completed, whichever is longer.  The sponsor will use and disclose 
participant study information only for research or regulatory purposes or to prepare 
research publications or presentations at meetings. 
 
A unique source record will be available for each study participant including 
documentation of the informed consent form review process, HIPAA completion to 
ensure patient privacy (United States), medical history, and concomitant medications 
review 
 
D. 
Provisions to Protect the Privacy Interests of Participants 
Subjects will only interact with approved members of the research staff, and will have 
the option to decline to provide any information that they are uncomfortable revealing.  
Federal Privacy Regulations provide safeguards for privacy, security, and authorized 
access.   
 
E. 
Compensation for Research-Related Injury 
There is no compensation available for research-related injury. 
 
F. 
Vulnerable Populations 
N/A 
G. 
Community-Based Participatory Research 
N/A 
H. 
Sharing of Results with Participants 
Study results will not be shared with the subject. 
 
I. 
Economic Burden to Participants 
There will be no cost to the subject to participate in the study. 
 
J. 
Withdrawal Criteria 
The term “discontinuation “refers to the participant’s premature withdrawal from the 
study prior to completing all procedures.  Participants may be discontinued from the 
study for any of the following reasons: 

 
 
 
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• Noncompliance. 
• At the request of the participant. 
• It the discretion of the site principal investigator if he/she believes continuing with 
the protocol is not in the best interest of the subject. 
 
The study coordinator will document whether or not each participant completed the 
study.  If, for any participant, study treatment or assessments were discontinued, the 
reason will be recorded. 
 
The study goal is to have 25 participants complete the entire study, and in order to 
complete this number we will attempt to recruit 30 couples to allow for drop out and 
screen fail. However, if a minimum of 15 participants are recruited we will begin the 
study. 
 
VIII. 
MONITORING AND QUALITY ASSURANCE 
All adverse events, serious and non-serious, occurring during the course of the study 
will be collected, fully documented, and reported to the Allendale Review Board (IRB) 
by the Sponsor. Serious adverse events will be reported to the Sponsor within 24 hours 
of the study team being aware of the event. For each adverse event, the investigator 
will provide the onset, duration, intensity and treatment required, outcome and action 
taken. We anticipate that adverse events during this study would be related to device 
usage.  Discomfort or pain in the jaw/mouth while using the myTAP V may occur. All 
reasonable care will be taken to avoid these complications. All data will be kept 
confidential and in a locked cabinet. Only approved study personnel will have access to 
study related documents. 
 
All device deficiencies, use or user errors, and equipment failures will be documented.  
Use or User errors will be captured as part of the source documentation.  Device 
deficiencies and equipment failures will be kept on a separate log.  The serial numbers 
and type of deficiency/failure will be captured. 

 
 
 
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This clinical study will be monitored by Philips Respironics Inc. (Sponsor) in compliance 
with the Code of Federal Regulations (CFR) for clinical research; namely, 21 CFR Parts 
50, 54, 56 and 812 and others as applicable. The purpose of such monitoring is to 
assure that the study remains in compliance with the approved protocol, investigator 
agreement and regulatory requirements, to verify the completeness and accuracy of 
study data and to resolve any issues that arise during the conduction of the study. The 
Sponsor will scheduled monitoring visits periodically as specified by the monitoring plan 
that will be conduct by trained clinical research professionals.  A unique source record 
will be created for each study participant.  This record will include documentation of the 
informed consent form review process, HIPAA competition according to site policies, 
concomitant medications and applicable medical history.  The Sponsor will have access 
to these source records.  An electronic data capture (EDC) will be used for this trial.  
Only those members of the study team that have completed training and have been 
delegated by the Principal Investigator will be able to access the EDC to enter data or 
make changes to the data. 
 
IX. 
REGISTRATION ON CLINICALTRIALS.GOV 
 
Pursuant to Philips QSP 7.9.4-2017 Registration and Disclosure of Clinical Studies, this 
trial will be registered with clinicaltrials.gov as some of the devices used in the trial are 
considered investigational and there may be a desire to publish results.  Therefore, 
participants will be consented that their de-identified data may be used in publication or 
teaching tools. 
 
 
 

 
 
 
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X. 
REFERENCES 
 
1. 
Huang, L., et al., Biomechanics of snoring. Endeavour, 1995. 19(3): p. 96-100. 
2. 
Lugaresi, E., et al., Some epidemiological data on snoring and cardiocirculatory 
disturbances. Sleep, 1980. 3(3-4): p. 221-4. 
3. 
Pevernagie, D., R.M. Aarts, and M. De Meyer, The acoustics of snoring. Sleep 
Medicine Reviews, 2010. 14(2): p. 131-144. 
4. 
Priegnitz, C. and W.J. Randerath, Conservative therapy for snoring. Somnologie, 
2014. 18(2): p. 96-100. 
5. 
Young , T., et al., The Occurrence of Sleep-Disordered Breathing among Middle-
Aged Adults. New England Journal of Medicine, 1993. 328(17): p. 1230-1235. 
6. 
Hoffstein, V., Snoring. Chest, 1996. 109(1): p. 201-222. 
7. 
Herzog, M., et al., Evaluation of acoustic characteristics of snoring sounds 
obtained during drug-induced sleep endoscopy. Sleep and Breathing, 2015. 
19(3): p. 1011-1019. 
8. 
Ieto, V., et al., Effects of oropharyngeal exercises on snoring: A randomized trial. 
Chest, 2015. 148(3): p. 683-691. 
9. 
Achuthan, S. and B. Medhi, A systematic review of the pharmacological 
approaches against snoring: can we count on the chickens that have hatched? 
Sleep and Breathing, 2015. 19(3): p. 1035-1042. 
10. 
Camacho, M., et al., Nasal Dilators (Breathe Right Strips and NoZovent) for 
Snoring and OSA: A Systematic Review and Meta-Analysis. Pulmonary 
Medicine, 2016. 2016. 
11. 
Dinardi, R.R., C. Ribeiro De Andrade, and C. Da Cunha Ibiapina, External nasal 
dilators: Definition, Background, and current uses. International Journal of 
General Medicine, 2014. 7: p. 491-504. 
12. 
Hoffstein, V., S. Mateika, and A. Metes, Effect of nasal dilation on snoring and 
apneas during different stages of sleep. Sleep, 1993. 16(4): p. 360-365. 
13. 
Höijer, U., et al., The Effects of Nasal Dilation on Snoring and Obstructive Sleep 
Apnea. Archives of Otolaryngology--Head and Neck Surgery, 1992. 118(3): p. 
281-284. 
14. 
Meen, E.K. and R.K. Chandra, The role of the nose in sleep-disordered 
breathing. American Journal of Rhinology and Allergy, 2013. 27(3): p. 213-220. 
15. 
Ravesloot, M.J., et al., The undervalued potential of positional therapy in 
position-dependent snoring and obstructive sleep apnea-a review of the 
literature. Sleep Breath, 2013. 17(1): p. 39-49. 
16. 
Benoist, L., et al., A randomized, controlled trial of positional therapy versus oral 
appliance therapy for position-dependent sleep apnea. Sleep Medicine, 2017. 
34: p. 109-117. 
17. 
Edwards, B.A., et al., Upper-Airway Collapsibility and Loop Gain Predict the 
Response to Oral Appliance Therapy in Patients with Obstructive Sleep Apnea. 
Am J Respir Crit Care Med, 2016. 194(11): p. 1413-1422. 

 
 
 
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18. 
Pancer, J., et al., Evaluation of variable mandibular advancement appliance for 
treatment of snoring and sleep apnea. Chest, 1999. 116(6): p. 1511-1518. 
19. 
Stouder, S., et al., Does an oral appliance reduce palatal flutter and tongue base 
snoring? Otolaryngology - Head and Neck Surgery, 2007. 136(5): p. 827-831. 
20. 
Kushida, C.A., et al., Practice Parameters for the Treatment of Snoring and 
Obstructive Sleep Apnea with Oral Appliances: An Update for 2005. Sleep, 2006. 
29(2): p. 240-243. 
21. 
Georgalas, C., The role of the nose in snoring and obstructive sleep apnoea: an 
update. European Archives of Oto-Rhino-Laryngology, 2011. 268(9): p. 1365-
1373. 
22. 
Analytics, H.R., Silent Night Value Concept Assessment. 2017. 
23. 
Papas, N.P. and K. Doty, Final Report, CAI-16023-SNOPIL-KD. 2017, Philips 
Respironics: Philips Respironics, SAP 803, MR. 
24. 
Dafna, E., A. Tarasiuk, and Y. Zigel, Automatic detection of whole night snoring 
events using non-contact microphone. PLoS ONE, 2013. 8(12). 
25. 
Gritti, F., et al. An automatic and efficient method of snore events detection from 
sleep audio recordings. 2011. Firenze University Press. 
26. 
Wang, C., et al., Automatic snoring sounds detection from sleep sounds via 
multi-features analysis. Australasian Physical and Engineering Sciences in 
Medicine, 2017. 40(1): p. 127-135. 
27. 
Jones, T.M., et al., Acoustic parameters of snoring sound to compare natural 
snores with snores during 'steady-state' propofol sedation. Clinical 
Otolaryngology, 2006. 31(1): p. 46-52. 
28. 
Johnson, M., Rhinomed's Mute Successful in Demonstrating Efficacy and Benefit 
in Snoring Trial. 2014: 
https://www.rhinomedshop.com/media/wysiwyg/021214_ASX_announcment.pdf. 
29. 
Braver, H.M. and A.J. Block, Effect of nasal spray, positional therapy, and the 
combination thereof in the asymptomatic snorer. Sleep, 1994. 17(6): p. 516-21. 
30. 
Choi, J.H., et al., Efficacy study of a vest-type device for positional therapy in 
position dependent snorers. Sleep and Biological Rhythms, 2009. 7(3): p. 181-
187. 
31. 
Lim, P.V.H. and A.R. Curry, A new method for evaluating and reporting the 
severity of snoring. The Journal of Laryngology & Otology, 2007. 113(4): p. 336-
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32. 
Chai-Coetzer, C.L., et al., A simplified model of screening questionnaire and 
home monitoring for obstructive sleep apnoea in primary care. Thorax, 2011. 
66(3): p. 213. 
  
 
 

 
 
 
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XI. 
APPENDICES 
  
 
Title 
Page(s) 
Appendix I 
SilentNight app v. 1.0.0 wireframe 
13 pages 
Appendix II 
Study OSA Screening Questionnaire 
1 page 
Appendix III 
Telephone Screening Script 
5 pages 
Appendix IV 
Phenotyping Questionnaire 
1 page 
Appendix V 
SNORER Intake Interview Guide 
5 pages 
Appendix VI 
BED PARTNER Intake Interview Guide 
4 pages 
Appendix VII 
Daily In-App questions 
2 pages 
Appendix VIII 
SNORER Crossover Visit Interview Guide 
3 pages 
Appendix IX 
BED PARTNER Crossover Visit Interview Guide 
4 pages 
Appendix X 
myTAP V Study Instructions for Use 
3 pages 
Appendix XI 
SNORER Exit Interview Guide 
3 pages 
Appendix XII 
BED PARTNER Exit Interview Guide 
4 pages 
Appendix XIII 
SNORER myTAP V Questionnaire 
2 pages 
Appendix XIV 
STOP-BANG 
1 page