Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Texas A&M University

Study Title: Midline traction versus bilateral thrust oral appliances: A randomized 
controlled trial to determine superiority for improving upper airway function and 
sleep quality. 
NCT03219034 
Study Protocol and Statistical Analysis Plan, November 14, 2019  

IRB Application (Human Research) (Version 1.4)
1.0
General Information
*Please enter the full title of your study:
Midline traction versus bilateral thrust oral appliances: A randomized controlled trial to 
determine superiority for improving upper airway function and sleep quality.
 
 
*Please enter a reference or other description for this study. This field is required, but will not be 
referenced by the staff. It is for your use:
RCT on oral appliance design for improving sleep
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
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the correct A&M System member.:
Primary 
Dept?
Department Name
TAMHSC - 
 - College Of Dentistry
Health Science Center
 
3.0
Assign key study personnel (KSP) access to the project
3.1 *Please add a Principal Investigator for the study:
 
Emet Schneiderman
 
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A) Additional Investigators
Bender, Steven 
 Additional Principal Investigator
Hui, Jason 
 Co-Investigator
McCann, Ann 
 Co-Investigator
Schramm, Preetam 
 Co-Investigator
Wilson, Phillip 
 Co-Investigator
B) Research Support Staff

German, Zohre 
 Study Coordinator
Marques De Moura, Pollyana 
 Grad Student
Newton, Margaret 
 Research Assistant
3.3 *Please add a Study Contact:
 
Bender, Steven 
German, Zohre 
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Opperman, Lynne 
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Version 11.14.2019
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10.0
 
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considered for and/or uploaded with this application for review and approval before use.
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* If the response to this question is Yes, then approval by an IRB in Qatar may also be 
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If Yes, please specify:
TAMCD Sleep Research Advisory Group
10.5  Fee for Service Information
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no company personnel are considered collaborators in the research (will not 
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If not yet available, submit it as an amendment form when available.
11.0
 
Study Scope
11.1  Research Classification
Select all that apply:
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For Social/Behavioral Research, select all that apply.
Questionnaire/Survey
Observation (investigator observing participants)
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Interview
Focus Group
Other, specify
11.2  
 
Vulnerable Populations  
Identify any vulnerable populations that will be included in the study:
 
Children (for example, in Texas, under 18)
Pregnant women, human fetuses, neonates
Individuals with physical disabilities
Individuals with cognitive disabilities
Economically or educationally disadvantaged persons
Prisoners
Other (for example, individuals with psychiatic disorders, emotional/social impairments, depression, 
etc.)
No Vulnerable Populations will be included.
If Other, then please explain:
 
Describe additional safeguards planned to protect the rights and welfare of vulnerable subjects:
 
If a subject transitions into one of the vulnerable populations (pregnant women or cognitively impaired), 
will the study procedures place them at any additional risk?
 
  Yes   
  No
If a subject becomes incarcerated (including awaiting sentencing, court-mandated treatment, or in 
prison), contact the IRB immediately.
 
Please justify the use of vulnerable/special populations.
12.0
 
Project Overview - Protocol Section Begins Here
12.1  
 
Project Summary
In the space below, provide a summary of the project. Include information about background and rationale for the 
study including preliminary data, purpose, objectives, specific aims, and research questions. Character limit: 5,000 
(applies to first box).
See Research Designs & Methods Below.
Procedures Involved:

In the space below, Describe and explain the study design. Provide a description of all research procedures 
being performed and when they are performed.
List each procedure or test and how often the procedure or test will occur for each participant.
Include a procedure schedule or table of events, if applicable - clinical studies.
Describe: All source records that will be used to collect data about subjects. This includes surveys, scripts, recordings 
and data collection forms; all test articles including dietary supplements, drugs and devices used in the research and the 
purpose of their use, and their regulatory (FDA) approval status.
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Drugs
Devices
Supplements
Significance:
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This study will compare the effectiveness of the two leading designs of oral appliances (OAs) for treating moderate 
to severe obstructive sleep apnea (OSA) in adults.  The effectiveness of OAs in patients with OSA has come under 
question since different designs have been lumped together, for example when comparing OAs to continuous 
positive airway pressure (CPAP) mask therapy.  Percent improvement in the apnea hypopnea index (AHI) has 
ranged from 53 to 90%, therefore it will be of great value to identify the most effective design to guide sleep 
practitioners and patients.
Subjects, enrollment, recruitment, inclusion and exclusion criteria, and informed consent:
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Texas A&M University College of Dentistry
CLINICAL TRIAL STUDY PROTOCOL
 
Title:   Midline traction versus bilateral thrust oral appliances: A randomized controlled trial to determine 
superiority for improving upper airway function and sleep quality.
Short Title:  RCT on oral appliance design for improving sleep
Principle Investigator:  Emet Schneiderman PhD, 
 Steven Bender, DDS
Co-Principle Investigator:
 
Co-Investigators: Jason Hui, DDS, Ann McCann RDH, PhD, Preet Schramm, PhD, Duane Wilson, DDS
 
Sponsor: Baylor Oral Health Foundation, Airway Management Inc.          
 
Projected duration of study  – July 1, 2017 to April 30, 2018
                             
 
 
 
 
 
 
 
I.ABSTRACT
      Background and Significance
      Sleep breathing disorders which includes obstructive sleep apnea (OSA) snoring, has an estimated prevalence 
of 3 – 7% of the adult US population.
 OSA subjects experiencing chronic sleep debt and intermittent nocturnal 
1 
hypoxia are more prone to health risks that includes carbohydrate metabolism imbalance, immune and endocrine 
dysfunction (Table 1).  Continuous positive airway pressure (CPAP) is the American Academy of Sleep Medicine 
2
(AASM) treatment recommendation for this highly prevalent disorder.  However, approximately 30% of OSA 
3
patients do not tolerate CPAP.4
Alternative treatment options for OSA include surgical interventions, mandibular advancement splint also referred 
to as oral appliance (OA) therapy, tongue retaining and hypoglossal nerve stimulating devices, but these have 
debatable efficacy in moderate and severe OSA. Efficacy differences in OA therapies treatment of moderate and 
severe OSA could be related to OA design variations although this hypothesis has not been tested.
Hoekema et al. (2007b) used a custom-fitted midline traction (MT) OA and found large improvements in Epworth 
Sleepiness Scale (ESS) scores, oxygen saturation levels, Quality of Life, Short Form (SF)-36 scores and the apnea 
hypopnea index (AHI) in a randomized control trial (RCT) in severe OSA subjects.  Three other RCT studies from 
5

Hoekema (2007a, 2008a, 2008b) and two other reports also used the same MT-device in moderate and severe OSA 
patients. 
 AHI improvements ranged from 80 to 90% (mean 85%). In contrast, several studies in moderate and 
6-10
severe OSA patients using bilateral thrust (BT) design failed to demonstrate an AHI reduction <10 events/hour 
although showing >50% AHI reduction (mean 55.4%; range 53 – 57%) from baseline conditions. 13-19
Of the OA studies considered in the American Academy of Dental Sleep Medicine (AADSM) practice guidelines, four 
(67%) used a MT OA, compared with only one (14%) in seven studies that used BT OA in severe OSA subjects 
(Table 2).
  The mean pre-OA AHI was 40.1 events/hour that reduced to a mean 5.7 events/hour post-treatment 
20
in the MT OA reports. The single BT OA study in severe subjects had a pre-treatment AHI equal to 30 events/hour 
that reduced to 14 events/hour at post-OA treatment.
Purpose: The two prominent OAs used in treating obstructive sleep apnea (OSA) 
differ in their designs, MT versus BT. From a clinical perspective, it is important 
to know which design is superior and should be the ‘treatment of choice’ for 
improving airway function and sleep quality. These two designs differ in their 
protrusive mechanisms that are categorized in general under four main types: 
bilateral compression, bilateral traction, midline compression and midline 
traction.  Although the two designs considered in this proposal have undergone 
the most rigorous testing individually, well controlled ‘head-to-head’ trials as 
proposed here have not been conducted to determine their efficacy within a 
single test population.
 Adults (n=44) with moderate to severe OSA  diagnosed by polysomnography (PSG) or home 
Patients/Methods:
sleep test (HST) within the previous year, who are using CPAP therapy, will be recruited and selected to enter the 
study. The study duration will be approximately nine months and each patient is expected to participate in the 
study for nine consecutive weeks. The first 4-weeks involve using one of either MT or BT OAs followed by 1-week 
washout period, then 4-weeks using the second OA. Home sleep recordings will be collected at T -first OA start; T -
1
2
end first OA; T -second OA start; T -end second OA. The primary outcome measure will be the respiratory 
3
4
disturbance index (RDI).
Table 1: Examples of sequela associated with OSA in adults.
Health Consequences
Adult
Excessive daytime sleepiness
√
Reduced Quality of Life
√
Accidents (i.e. occupational, motor vehicular)
√
Hypertension
√
Cardiovascular disease
√
Obesity
√
Neuromuscular disorders
√
Sleep quality
√
ADHD
√
Learning difficulty; Cognitive impairment; Dementia; Alzheimer’s 
Disease
√
Behavior problems
√
Sleep-walking
√
Hormonal & metabolic problems
√
Bruxism
√
Depression
√
Impotence
√
 
 
 
Table 2: Select oral appliance studies using midline traction and bilateral thrust
Device
Study
post AHI
pre 
AHI
#pts
 
%
improvement
TAP  -MT
Hoekema2007a
3.2
20.4
20
Moderate
84%
TAP - MT
Hoekema2007b
5.2
50
9
Severe
90%
TAP - MT
Hoekema2008a
4
31
12
Severe
87%
TAP - MT
Hoekema2008b
7.8
39.4
51
Severe
80%

TAP - MT
Holley 2011*
8.4
30
497
Severe
72%
TAP - MT
Ghazal 2009
7.9
22.2
48
Moderate
64%
Somnodent - BT
Deane 2009
12
27
22
Moderate
56%
Somnodent - BT
Gotsopoulos 2002
12
27
73
Moderate
56%
Somnodent - BT
Gotsopoulos 2004
12
27
67
Moderate
56%
Somnodent - BT
Mehta 2001
14
30
28
Severe
53%
Somnodent - BT
Naismith 2005
12.2
26.9
73
Moderate
55%
Somnodent - BT
Phillips 2013
11.1
25.6
126
Moderate
57%
Somnodent - BT
Sutherland 2011
12
26.9
39
Moderate
55%
Abbreviations: TAP – MT, Thornton appliance positioner – midline traction; BT, bilateral thrust.
 
 
II.Formulation of the Problem – Introduction
      Obstructive sleep apnea (OSA) is a disease in which repetitive apnea and hypopnea (cessation and reduction in 
airflow, respectively) events occur during sleep because the upper airway (UA) has become blocked or narrowed (i.
e. via mechanical collapse). 
 The development of UA occlusion can be related to oropharynx anatomical features 
21
and decline in pharyngeal neuromuscular activity. 
Walsh et al. (2008) evaluated the cross-sectional area of the 
22 
pharyngeal airway in OSA subjects compared with controls and found OSA subjects had smaller sized 
velopharyngeal cross-sectional area, longer uvulas compared with controls suggesting an abnormality in size rather 
than shape was an anatomical predictor of OSA. 23
OA designs vary which could impact their efficacy in treating OSA. The therapeutic goal is a >50% reduction from 
baseline AHI values and <10 apnea and hypopnea events/hour.
It is important to know from a clinical perspective whether the MT or BT design 
is superior and should be the ‘treatment of choice’ for improving airway function 
and sleep quality. To date, no well controlled ‘head-to-head’ crossover trials as 
proposed here have been conducted in determining their AHI efficacy and impact 
on sleep quality.
 
a.Approach to the Problem: OA devices are recommended as the first-line 
treatment for mild to moderate OSA and second-line therapy for severe 
OSA. By advancing the mandible forward during sleep, OAs facilitate and 
maintain an increase in the oropharyngeal lumen. 
 It also decreases 
23
airway collapsibility compared with no OA intervention, to enable proper 
breathing.
Our intent is to perform a randomized controlled ‘head-to-head’ crossover 
trial in which the same patient uses two types of OA designs to determine 
their RDI efficacy and impact on sleep quality.
 
b.Justification: The increase in oropharyngeal space created by advancing the 
mandible with OAs has shown efficacy in reducing the number of apnea 
events, comparable AHI reduction results with CPAP  and improvements 
8
in secondary health benefits. 
 Furthermore, several studies provide 
5,6,8
evidence that OA compliance is greater among OSA patients using OA 
therapy compared with CPAP use. 20

1.Principle of Operation: Midline Traction Oral Appliance 
 (Figure 1) A 
11
coupling mechanism located at a single point midline, allows 
adjustment by incremental protraction of the mandible by the patient, 
see Hoekema .
7
2.Principle of Operation: Bilateral Thrust Oral Appliance 
 (Figure 2) A 
12
bilateral torsion adjustment mechanism constructed from surgical 
grade stainless steel allows for the mandible to be pushed forward. The 
patient can modify the amount of protrusion by adjusting the 
mechanism on each of the two sides, but this cannot be done while in 
the mouth.
c.Investigative question
Does the MT or BT device provide greater RDI reduction to an acceptable level (<10 
apnea and hypopnea events/hour of recorded sleep or >50% change) from pre-
treatment values in adult patients with moderate to severe OSA?
 
III.Theoretical framework
The UA consists of the nasopharynx, oropharynx and hypopharynx. The oropharynx is essentially a tube of 
tissue derived from embryonic pharyngeal arches. Its patency is maintained by the tensor veli palatini and the 
genioglossus muscles.  The oropharynx is that part of the pharynx (throat) posterior to the oral cavity.  Its 
volume is constrained by the size and position of the tongue, the soft palate, uvula, tonsils, and pharyngeal 
muscles relative to the hard-tissue framework formed by the teeth, maxillary complex, mandible and hyoid 
bone. The genioglossus muscle originates at the superior genial tubercle of the mandible and fans into the 
substance of the tongue (intrinsic tongue muscles). The geniohyoid muscle originates at the inferior genial 
tubercle and inserts into the hyoid bone.
During normal breathing, swallowing and phonation, detectable physiological changes occur within the 
oropharynx. During wake in an upright position, the normal breathing position of the mandible is at ‘rest’ in a 
plane parallel to the maxillary plane.23
OSA begins with sleep onset, is commonly due to collapse of the UA and almost all patients with OSA snore.
 
24
At sleep onset, the UA undergoes both functional and structural changes, leading to spatially and temporally 
distributed sites conducive to snore sound generation.
 Particularly in a supine sleep position, reduced 
22
genioglossus muscle tone allows the tongue to fall posteriorly towards the pharyngeal wall. Encroachment of 
the tongue into the airflow lumen increases airflow turbulence, thus producing soft tissue vibration and snoring 
sounds. Other factors also impact the airway’s luminal diameter including obesity, craniofacial abnormalities 
like micrognathia and retrognathia, enlarged palatine tonsils and uvula, a high-arched palate, nasal septal 
deviation, large tongue, long soft palate and small airway lumen. Nasal valve collapse Gender differences, age 
and genetic factors may also have an impact on airway resistance. Sedatives can further relax the airway’s 
musculature and alcohol’s sedative effect increases snoring and apneic events. Cigarette smoking can cause 
inflammation within the oral cavity reducing the lumen’s size. 25
Partial closure of the airway during sleep that results in reduced airflow from 30 – 50% for ≥ 10 seconds with 
maintained respiratory effort and associated oxygen desaturations is defined as an obstructive hypopnea. 
Cessation of airflow for ≥ 10 seconds with maintained respiratory effort and associated oxygen desaturations 
of 2 – 4% is defined as an obstructive apnea. Both events are followed with an autonomic arousal, increase in 
muscle tone and resumption of breathing effort. It is the cumulative number of apneas and hypopneas divided 
by the number of hours of sleep that results in the AHI. 3
An increase in oropharyngeal space created by advancement of the mandible occurs in association with inferior 
movement of the condyles that causes the posterior aspect of the mandible to move away from the maxilla 
(Christensen’s phenomenon). 
 The mandible’s forward movement away from the maxilla stretches and 
21
tightens the lateral walls of the pharynx with the superior constrictor muscle through attachments that includes 
the tongue. 
 Furthermore, this space creating forward movement allows the tongue to rest behind the upper 
21
incisors to form an air seal with the soft and hard palate that then facilitates nose breathing. 
 An OA’s 
21
mechanics to move the mandible forward should increase oropharyngeal space with concomitant reduction in 
the number of apnea and hypopnea events through increased forward torque on the lumen’s surrounding 
musculature.
 
IV. Table 3: Information about the OAs
 
Midline Traction OA
Bilateral Thrust OA

1.  
2.  
3.  
a.  
1.  
Provides customized 
fit for each patient
√
√
Uses separate upper 
and lower tray pieces
√
√
Advances mandible 
incrementally
√
√
Advancements 
performed by a 
dental sleep specialist
√
√
Single contact point 
between upper and 
lower trays
√
 
Pulls mandible 
forward
√
 
Two contact points 
between upper and 
lower trays
 
√
Pushes mandible 
forward
 
√
 
V.Hypothesis
H  : The RDI will not differ when treating adults with moderate to severe (>15 events/hour) OSA between the 
0
MT and BT devices. H : The MT device / intervention will provide greater reduction in the RDI from pre-
A
treatment values than the BT device in adults with moderate to severe OSA.  Secondarily, proportions of 
responders to MT device intervention who’s RDI is reduced to an acceptable level (< 10 events/hour or >50% 
change from pre-treatment values) is expected to be higher with MT therapy.
VI.Objectives
The main study objectives are to:
Quantify the RDI with each OA at the start and end of four weeks of use.
Compare the RDI of each OA with pre-treatment PSG determined AHI to evaluate the percent reduction.
Characterize global sleep quality changes associated with the use of the OAs.
We endeavor to model real-world conditions for measuring sleep by utilizing HST and recording in the subject’
s own sleep environment. Based on previous research, we expect reduction in the RDI with OA use and 
superior response with the MT OA.
VII.Methods
Study type
Single center, cross-over randomized control trial; superiority trial

2.  
b.  
1.  
2.  
3.  
4.  
c.  
d.  
e.  
Interventional comparative effectiveness research
Population
Adults (n=44) with moderate to severe OSA.
Potential study participants will be recruited by means of flyers posted at the College of Dentistry, 
Dallas A.W.A.K.E. office (support group for sleep apnea patients) and Dallas area sleep 
clinics.  Online postings at clinicaltrials.gov and the College web site. Also post flyers at (1) regional 
hospitals and clinics, (2) city and county offices/stations (such as the Dallas Fire Department), (3) 
DART and other transportation offices and (4) Facebook, Twitter and similar site, (5) local 
newspapers and magazines, (6) local radio stations.  The content of the advertisements on venues 
(5) and (6) will be the same as the approved flyers.  Written permission will be sought from all sites 
at which flyers are to be posted. Data analyst and subjects will be blinded to treatment device type (i.
e. sequence of use of the two OAs) and subject’s identity will be coded.
Controls and Controlling Confounders:  Subjects serve as their own controls; their baseline 
polysomnography (PSG) or Home Sleep Test (HST), untreated values (from full or split night PSGs) 
will serve as their control values for evaluating treatment effects with each of the two OAs.  The 
focus of the trial is on comparing OA appliance efficacy in reducing the RDI (AHI); the presentation, 
fitting, monitoring and adjustment of the two OAs will be the same for both arms of the study. For 
the operators, there will be concealed allocation of assignment of subjects to treatment.
Performance Site:  Texas A&M College of Dentistry, 3302 Gaston Avenue, Dallas Texas.  Seventh 
floor room 725, two operatory clinic.
 
Inclusion criteria
OSA diagnosed adults, at least 18 years old,  who have been recently diagnosed by 
polysomnography (PSG) or polygraphy home sleep test (HST) in the previous year and are 
currently being treated with continuous positive airway pressure (CPAP) having an AHI > 15 
events/hour of sleep; two or more OSA symptoms (snoring, witnessed apnea or daytime 
hypersomnolence complaint);  at least 8 teeth per arch to support either OA device; Mallampati 
score from I to III; Palatine tonsils – grade 0, 1, or 2;  Central and mixed apnea index < 5 events
/hour. Consent to study’s timeline;  willingness to wear home sleep test apparatus for at least 4 
nights and to wear an oral appliance every night for 8 weeks; willingness to pick up and return 
home sleep test kits as needed.
 
Exclusion criteria
 
Cardiac & pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD); central 
sleep apnea; comorbidities of other sleep disorders other than OSA; no active TMD or jaw muscle 
pain, morphological airway abnormalities, BMI ≥35; pre-existing difficulty swallowing; throat or 
neck related health issues; endocrine dysfunction; severe psychiatric disorders; intellectually 
disabled; previous OA therapy; previous ENT surgery; restrictions in jaw opening; pregnant / 
breast feeding or intent to become pregnant during the study; inability to provide informed 
consent and apply the HST recorders.
 
Table 4: Variables of Interest: Primary, Secondary and Exploratory
 
Primary
Secondary
Exploratory
Variables
RDI-
T -start-of-treatment 
1
with first OA; T -end-
2
of-treatment with 
second OA; T -start-of-
3
treatment with first 
OA; T -end-of-
4
treatment with second 
OA
T
Snore count;
1-4 
OA compliance;
Mean disease 
alleviation; Sleep 
Quality
T
Epworth 
0, 2, 4 
Sleepiness Scale score; 
Short Form-36 score
Thornton snoring scale
Sleep observer scale
Symptom alleviation
Changes in occlusion as 
measured by shim 
stock, tested before 
and after
T
OA device 
4 
preference and 
perceptions of comfort;
Development of a cost 
effective titration 
protocol with maximal 
patient convenience.
 
Mean disease alleviation is a composite measure of the reduction in RDI and OA compliance. RDI, respiratory 
disturbance index equals the number of respiratory events per hour of recorded time; T 
, time points 1-4
1-4
 

f.  
1.  
i.  
2.  
i.  
3.  
i.  
g.  
h.  
i.  
Data collection techniques to be used during sleep
OA compliance
This variable is determined by the number of hours that the OA device is worn per hour of 
sleep per night using Braebon monitors (integrated chips; Kanata, Ontario, Canada)
Respiratory measures (Figure 3)
Braebon polygraphy (PG) recorder for home sleep testing: airflow, respiratory effort, 
electrocardiogram (ECG), pulse oximetry, anterior tibialis electromyography, body position, 
and snore sound.
The PG unit is a category Type III sleep testing device. Manually scored sleep disordered breathing events 
will be categorized as apnea or hypopnea (RDI; ≥5, >15, >30 events/hour) and phenotyped as either 
obstructive or central type events. Mixed events will be assigned to the OSA category. The definition of 
apnea to be used will be a ≥90% reduction in airflow from baseline and ≥10 seconds in duration. 
Hypopnea will be defined as a reduction in airflow of ≥30% with an associated oxygen desaturation. The 
RDI will be defined as the number of apnea-hypopnea events divided by recorded hour. 3, 24
Sleep quality assessment (Figure 4, 5)
SleepImage (MyCardio, LLC, Broomfield, CO) recorder: ECG, actigraphy, body position, snore, ECG-
derived respiration
The SleepImage system includes a sleep recorder that is clinically validated and FDA cleared to allow the 
non-intrusive collection of objective measures of sleep quality. The ECG-recorder with cardiopulmonary 
coupling (CPC) analysis collects ECG, actigraphy, snoring and body position data at a sampling rate of 600 
Hz that is later filtered to sampling rates of 200, 40, 10 and 10 Hz, respectively. The ECG-recorder’s sleep 
data are uploaded and scored automatically. CPC algorithms assess the ECG’s R-wave amplitude change 
associated with tidal volume dynamics to derive a respiration (ECG-derived respiration) signal. The 
resulting sleep spectrogram, divides sleep states into “stable sleep” (0.1–0.4 Hz) and “unstable sleep” 
(0.01–0.1 Hz). 
 Within 0.01-0.1 Hz is the “narrow band” that identifies central-periodic type patterns 
26
(0.006–0.1 Hz) and obstructive type events primarily through a “broadband” (0.0–0.01 Hz, not fitting 
narrow band criteria) pattern. 
 Between-treatment differences in the proportions of stable and 
27, 28
unstable sleep will be evaluated.
Subjective measures related to the sleep experience of the subjects will also be collected using 
these  questionnaires at T , T  and T
: Eppworth sleepiness scale, Quality of Life Short Form-36, version 
0
2
4 
2 and the Thornton snoring Scale.
Data collection
Treatment devices: TAP 1 (Airway Management Inc., Dallas, TX; MT type OA device) and SomnoDent Flex 
(SomnoMed, Plano, TX; BT type OA). Both OA devices will be used per manufacturers’ recommendations. 
To insure comparability, both devices have a custom thermal acrylic liner insuring a very accurate 
fit.  Each subject will also be custom fitted with a mandibular positioner (“AM Aligner” or “Morning 
Positioner” ) to use for up to 20 minutes after awakening in the morning; this will assist in returning the 
subject to his/her normal occlusion.
Appliance Acclimation:  Both appliances will be adjusted / titrated to the patient’s maximal comfortable 
protrusive position by patient in the wake state. The starting position will be determined by the patient at 
a comfortable position but not less than 60% as determined by the Pro Gauge. “Comfortable” is defined as 
the advanced mandibular position that permits the subject to sleep for ≥5 hours per night for at least 6 
nights of the week. Subjects will use diaries to record appliance settings and hours of sleep on each sleep 
recorded or non-recorded night. Two follow-up nights (post T ) of SleepImage recordings only will be 
1
made to track sleep quality and OA position, if further mandibular adjustments are necessary as 
determined by the T  & T  HST and SleepImage results.
1
3
Course of Treatment: Subjects will be randomly assigned to either the MT- or BT-first OA device as 
treatment for OSA.  Each subject will use the first OA for 4 weeks followed by – 1 week washout period 
that includes using nightly their prescribed CPAP and daytime use of a mandibular positioner (for up to 20 
minutes) – then another 4 weeks of active treatment with the second OA.
 
Power Analysis and Sample Size
 
At least 38 subjects with OSA are needed to yield a power of 0.90 with alpha = .05 and an expected Effect Size of 
at least a 10 point difference in the post-treatment mean RDI scores between MT vs. BT devices.Recruitment will 
be extended to n=44 to accommodate an estimated 20% drop-out rate. The projected numbers are based on 
Wilcoxon signed-rank test where the expected difference between-treatments (cross-over design) is expected to be 
at least 10 point difference in RDI scores.
 
Statistical analyses

1.  
j.  
k.  
1.  
2.  
3.  
4.  
Wilcoxon signed-rank test (matched pairs) for cross-over design for primary variables will be used.  For 
dichotomous secondary variables, data analysis will use logistic regression to adjust for effects of initial 
severity, age, gender, BMI, ethnicity, SES, phenotypic differences, etc. t-tests and Mann-Whitney tests as 
needed for non-dichotomous outcomes, depending upon normality.  Descriptive statistics (means, 
standard deviation, medians, interquartile ranges) for each outcome measure will be calculated and bar, 
boxplot or line graphed for each time point. Repeated measures analysis of variance, parametric or 
nonparametric one-way analysis of variance, as appropriate, will be used to determine if each of the 
outcome measures vary across the time points.
Handling of missing data
For the primary study endpoint, several methods will be used, including: 1) last observation carried 
forward, 2) multiple imputations, and 3) imputing a missing value with the group’s mean value at that 
follow-up and frequency.
The set of missing data analyses will serve as a sensitivity analysis for the primary study outcomes.If 
the data imputation methods for a given endpoint result in disparate statistical inferences, the 
differences will be investigated and elucidated in the final clinical study report.
 
Right and Safety of Research Participants
The clinical trial will be conducted in accordance with the ethical principles that have their origin in the Declaration 
of Helsinki and the Belmont Report and that are consistent with Good Clinical Practice (GCP). The laws, regulations 
and rules of the United States, the state of Texas and the Texas A&M University pertaining to human subjects 
research will be followed.The rights, safety, and well-being of the trial subjects are the most important 
considerations and will prevail over the interests of science and society. The available clinical information on the OA 
devices is adequate to support the proposed clinical trial.
 
Freely given informed consent will be obtained from every subject prior to clinical trial participation. All patient 
clinical trial information will be recorded, handled and stored in a way that allows its accurate reporting 
interpretation and verification. The confidentiality of records that could identify subjects will be protected, 
respecting the privacy, confidentiality rules and to ensure non-bias reporting requirements.
 
During the approximately 2-hour Visit 1, the prospective subject will be given an oral exam by one of the 
team dentists to insure that the dentition, periodontium, temporomandibular joints, muscles of mastication 
are sufficiently healthy and stable for the safe participation in the study. If determined to be sufficient, the 
subject will then be fully enrolled in the study and have the study and tasks explained in greater detail. 
Dental impressions will then be obtained as models for the fabrication of the custom oral appliances.
 
Potential risk to subjects
The minor physical risk associated with the sleep-monitoring aspects of this study are no more than those 
involved with standards test of bodily (physiological) functions, for example wearing a heart monitor. The 
oral appliances are FDA cleared and are in wide use by dental patients throughout the US.  The oral 
appliances (OAs) are FDA cleared and are in wide use by dental patients throughout the US.  The OAs may 
cause pain in the jaw joint and teeth, and difficulty in opening or closing the jaw; these conditions are 
usually temporary.   In the long term, the OAs may cause changes in tooth position and in the bite 
(occlusion), as well as damage to the teeth and gums.  What makes this experience “research” rather than 
“routine clinical care" is that (1) the participants are randomly assigned to one OA or the other during the 
two active phases of the study, and (2) additional physiological measurements will be made beyond what 
are typically gathered during standard clinical practice. All of these tests are noninvasive.
We do not anticipate any significant physical risk from participating in this study. Though unlikely, some 
subjects may experience itching or rashes from the adhesive hypoallergenic electrodes of the Medibyte or 
the SleepImage devices. The pulse oximeter may cause some minor irritation of the finger or finger nail. 
By wearing an OA, a subject may experience some discomfort and/or reduced function of the jaw joint 
(temporomandibular joint) and muscles of the jaw (masticatory muscles) and of the face during and after 
treatment. Subjects may also experience some reduction in sleep quality due to discomfort while getting 
used to wearing the OA (acclimation). Other minor risks include temporary irritation of the mouth and oral 
cavity due to contact with the OA, and excessive salivation or dry mouth from mouth breathing. 
Repositioning of the lower jaw and tooth movement may also occur, but are typically minor and 
reversible.  Also highly unlikely,  a subject could swallow or aspirate part of an OA should it break.
 
     l. Potential benefits to subjects
Two customized oral appliances to keep upon completion of the study at no cost to the subject (value of 
$4600)
Effective devices that do not require electricity to operate, so can be used anywhere
Reduced apnea and snoring
Improved sleep quality and continuity

5.  
6.  
7.  
8.  
1.  
i.  
ii.  
iii.  
iv.  
An effective treatment for obstructive sleep apnea that does not require wearing a face mask
No air pressure blowing through nose
Receiving information on sleep quality.
The researchers or study coordinator will discuss possible options that might be of benefit if a sleep issue is 
discovered.
 
Study Limitations
 
Hyperarousal response to the OA. Possible brief OA acclimation (4-weeks) and washout (1-week) period. No 
placebo device as a control condition. Interrater variability of HST polygraphy scoring. No controlled sleep 
environment which allows for variability in external conditions during sleep recordings. Absence of conventional 
sleep staging based on EEG activity.
 
Adverse events and adverse device effects
Definitions
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury or any untoward clinical 
signs (including an abnormal laboratory finding) in subjects, users or other persons 
whether or not related to the investigational OAs. This includes events related to the 
investigational devices and this includes events related to the procedures involved (any 
procedures in the clinical investigation plan). For users or other persons this is restricted 
to events related to the investigational OAs.
Adverse Device Effect (ADE)
Adverse event related to the use of the OA. This includes any adverse event resulting 
from insufficiencies or inadequacies in the manufacturer’s instructions for use, the 
deployment, the installation (customization procedure), or any malfunction of the 
investigational devices. This includes any event that is a result of a use error or 
intentional misuse.
Serious Adverse Event (SAE)
A serious adverse event is considered when it:
a. Leads to death,
b. Leads to a serious deterioration in health that either resulted in a life-threatening 
illness or injury, or resulted in a permanent impairment of a body structure or a body 
function, or required in-patient hospitalization or prolongation of existing hospitalization, 
or resulted in medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function.
 
This includes device deficiencies that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate. These are handled under the SAE reporting 
system.
A planned hospitalization for pre-existing condition, or a procedure required by the 
Clinical Investigation Plan, without a serious deterioration in health, is not considered to 
be a serious adverse event.
Unanticipated Serious Adverse Device Effect
Unforeseeable serious adverse device events, are those having severity and occurrence 
not identified in the latest version of the report of the risk analysis. Consideration will be 
given to the:
severity of the event
corrective measures
preventions from re-occurrence
The corrective measures are to be determined immediately and to be implemented. It is 
to be assessed whether the study can be continued.
 
The investigator(s) must determine whether the complication which may occur, was 
expected or unexpected. For this he or she must review the personal conditions and 
medical history of each study subject in question and determined, if the event was 
referenced in the protocol. An unexpected event is an event, which has not been 
mentioned in the study protocol.

v.  
vi.  
vii.  
viii.  
ix.  
a.  
Documentation and reporting of SAEs
Every adverse event that meets the criteria for an unanticipated problem must be 
reported to the IRB within 5 days.
Protocol deviations
The Principal Investigator(s) is responsible for the conduct of the clinical trial. The PI will 
follow established procedures for the evaluation, approval and implementation of 
deviations to the study protocol and the reporting of protocol deviations as appropriate to 
the IRB.
Early study termination
The study will be suspended immediately if unexpected high levels of complications occur 
and /or Adverse Device Effects occur which are unexpected in nature and/or severity as 
determined by the investigator(s) or IRB. The trial will not be resumed without IRB 
approval.
Quality control
Study monitoring procedures ensure that the clinical trial is conducted in accordance with 
the study’s protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), 
and applicable requirements.Trained and qualified members of the trial team will conduct 
investigational site visits throughout the study period in coordination with the Study 
Coordinator.
OAs and sleep recording devices accountability
The physical location of all devices from shipment of devices to the clinical investigation 
site until return or removed from use due to malfunction will be documented by the 
Study Coordinator or Principle Investigator.The clinical investigation site also maintains 
controlled access to the investigational and recording devices and maintains that devices 
will only be used according to the study protocol.The investigation site must maintain 
records documenting the receipt, use, return and malfunction of the investigational 
device and sleep recorders with date of receipt, identification of device with serial or ID 
number, dates of use, subject identification, date on which investigational device was 
returned from subject, and date of unused or malfunctioning devices.
 
VIII.Ethical Considerations
The rights, safety, and well-being of the study’s subjects are the most important considerations and will prevail 
over the interests of science and society.  The available non-clinical and clinical information associated with the 
investigational OAs is adequate to support the proposed clinical trial.  The clinical trial is scientifically sound and has 
been described in a clear, detailed protocol herein.
The trial will be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) 
approval.
The care given to and decisions made on behalf of, subjects will be the responsibility of a qualified dentist and each 
individual involved in conducting the trial will be qualified by education, training, and experience to perform his or 
her respective task(s).
Freely given informed consent will be obtained from every subject prior to clinical trial participation.
All clinical trial information will be recorded, handled and stored in a way that allows its accurate reporting 
interpretation and verification.
The confidentiality of records that could identify subjects will be protected, respecting the privacy and 
confidentiality rules in accordance with the applicable regulatory requirements.
IX.Schedule
The study duration will be approximately nine months. Each subject 
from the time of initial OA use and sleep data recording will be 
involved in the study for approximately 9 weeks. (Figure 6)
 
Recruitment criteria & methods: Potential study participants will be recruited from the Texas A&M College of 
Dentistry (TAMCD), local A.W.A.K.E. group.   Invitation to participate in the study will be by bulk email and 
posted flyers.  The study will be registered with ClinicalTrials.gov. Data analyst and subjects will be blinded 
to treatment device type (i.e. sequence of use of the two OAs) and subject’s identity will be coded.

b.  
c.  
d.  
After meeting the study’s inclusion and exclusion criteria through telephone screening, study subjects will 
receive detailed information about the study from the Study Coordinator during their first appointment. The 
first appointment to the study center will include obtaining a copy of the patient’s PSG/CPAP study reports 
and medical history, completion of the study’s intake assessment, signing the informed consent form and 
obtaining impressions and protrusive bite.  In the absence of a current PSG, subjects will be sent home with 
a HST to collect comparable baseline information.  Both oral appliances will be constructed prior to the 
second appointment. The subjects will be randomized to an OA device at second appointment  (this will 
allow any questions by the lab of the dentist to improve the device). During the second appointment, 
subjects will be examined and fitted by the dentist with both OAs. Subjects will be then scheduled within 4-
weeks for the first HST with simultaneous SI recording for determination of the RDI and sleep quality 
criteria. Recordings will occur x1/subject at T  (first night in week-1 with first OA), T  (after four weeks 
1
2
using first OA), a washout period of 1 week using a mandible repositioner daily and CPAP nightly, T  (first 
3
night of week-6 with second OA) and T  (after four weeks using second OA). (Figure 1, below; Table 1)
4
 Table 5:  Protocol for determining subject candidacy:
EVALUATION
PURPOSE
PROCEDURE/RATIONALE
Recruitment / 
Orientation
Provide information 
about the study.
Provide the subject with information regarding the OA 
devices, the clinical study and an information brochure.
Medical Background 
Information
 
Gather information 
regarding the subject’s 
medical background to 
determine candidacy, 
and recent sleep study 
evaluations.
Standard medical case history and physical with 
emphasis on OSA to include the Medical/Surgical History 
as part of the Case Report.
Conducted individually by the team/Study Coordinator 
and discussed collectively to ensure that the subject has 
realistic expectations for the study.
Craniofacial & Oral 
Testing
Verify subject 
qualification with a 
craniofacial / oral 
exam.
Clinical assessment is performed to examine the upper 
airway and oropharynx to determine the subject 
qualification for using OA therapy.
Informed Consent
Obtain informed 
consent.
Informed consent will be obtained by providing 
information related to the time commitments of the trial, 
risks and contraindications.
 
Table 6:  Protocol For Pre-OA Evaluations
EVALUATION
PURPOSE
PROCEDURE/RATIONALE
Pre-study AHI
Subject’s own baseline 
AHI data for comparison 
to OA response
PSG or PG conducted within up to 1 year before study 
inclusion for baseline AHI/RDI
Pre-study 
questionnaire
Quality of life 
questionnaire for 
comparison to OA 
response
Complete the Epworth sleepiness scale and quality of life 
or functional outcomes sleep questionnaire. This data 
will be performed on the same day as sleep studies (T
)
1-4
.
Snore Index
Baseline snore index for 
comparison to OA 
response
Data collected as a part of PSG.
Number of Periodic 
Limb Movements 
(PLMS)
Baseline number of PLMS 
with arousals to 
determine study 
inclusion or exclusion
Data collected as a part of PSG. This is a study exclusion 
criteria.
Number of Central 
Sleep Apnea (CSA) 
events
Baseline number of CSA 
events to determine 
study inclusion or 
exclusion
Data collected as a part of PSG. This is a study exclusion 
criteria.
 
Table 4: Protocol for OA use and home sleep recordings
TASK
PURPOSE
PROCEDURE/RATIONALE
Oral Appliance, 
Home Sleep Test and 
SleepImage 
recorders orientation
To instruct subjects on how to 
apply, use, care for, remove 
and return the OAs, sleep 
recorders to obtain optimal 
recordings.
Explain and demonstrate OA use; provide 
instructions regarding the correct application and 
removal of HST electrodes and sensors. To provide 
instructions on care and return of study equipment 
for optimal data collection and timely return of 
equipment.

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
10.  
11.  
12.  
13.  
Completion of sleep 
diary and 
questionnaires
To instruct participants on how 
and when to complete the 
sleep diary and questionnaires.
The proper completion of the sleep diary and 
questionnaires facilitates assessment of the study’
s secondary outcome measures.
Adverse Device 
Effects reporting
To instruct the study subject 
on the definition of an Adverse 
Event and how to report an 
event.
To ensure the study subject’s safety and health, 
whether or not the changes are believed to be 
device related. 
 
 
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Padma A, Ramakrishnan N, Narayanan V. (2007) Management of obstructive sleep apnea: A dental 
perspective.Indian J Dent Res 18:201209
 
Thomas RJ, Mietus JE, Peng CK, Goldberger AL. (2005) An electrocardiogram-based technique to assess 
cardiopulmonary coupling during sleep. SLEEP; 28:1151-61.
 
Thomas RJ, Weiss MD, Mietus JE, Peng CK, Goldberger AL, Gottlieb DJ. (2009) Prevalent hypertension and 
stroke in the sleep heart health study: association with an ECG-derived spectrographic marker of 
cardiopulmonary coupling. SLEEP; 32(7):897-904.
 
 

28.  Thomas RJ, Mietus JE, Peng CK, Gilmartin G, Daly RW, Goldberger AL, Gottlieb DJ. (2007) Differentiating 
obstructive from central and complex sleep apnea using an automated electrocardiogram-based method. 
Sleep; 30:1756-1769.
 
{GO TO ATTACHED PROTOCOL FILE TO VIEW THE FOLLOWING CORRECTLY}
 
Figures 1 and 2
  
 
Figure 1. TAP 1 Oral Appliance (MT Style)                            Figure 2.  SomnoDent Flex Oral Appliance (BT Style)
 
 
 
Figure 3: Home Sleep Test device in recording position.
Figure 5: Sleepimage sleep device actual size.
Figure 4: Sleepimage sleep device in recording position.
 
Will audio recordings be collected?
  Yes   
  No
Will visual images be collected?
  Yes   
  No
If visual images will be collected, are they full, facial identifiable images?
  Yes   
  No
12.2  Locations
List locations or facilities where the research will be conducted (e.g. building name, physical address).
TAMU College of Dentistry Building at 3302 Gaston Avenue, Dallas TX 75246
Are any of the locations listed above non-Texas A&M facilities?
  Yes   
  No
What is the role of each location?
Is the PI of this IRB study application the lead investigator of a multicenter study (i.e. the study is taking 
place at multiple institutions that are obtaining their own IRB approval and you are coordinating and 
overseeing the research)?
  Yes   
  No
Has IRB approval been sought at another institution?
  Yes   
  No
Please submit the Site Authorization letter(s) with this application as a study document or indicate when 
site authorization will be obtained. Guidance is available at http://rcb.tamu.edu/humansubjects
/resources/site-authorization-letter
12.3  Other Committee Approvals
Select all that apply.
None
Animal Use
Biohazards

Chemical
Radiation
Other
If any committee approvals apply, please provide the permit number and approval date.
13.0
 
Study Population
13.1  Number of Participants
Approximately how many subjects do you plan to enroll?
 
38
Provide the rationale for the number of subjects requested (for example, power analysis, sponsor 
requirements, etc.).
 
Approximately 38 subjects must complete the study to yield a power of 0.90 with alpha = .05 and an 
expected Effect Size of at least a 10 point difference in the post-treatment mean RDI scores between MT 
vs. BT devices. Recruitment will be extended to n=44 to accommodate a 10-20% drop-out rate. The 
projected numbers are based on Wilcoxon signed-rank test where the expected difference between-
treatments (cross-over design) is expected to be at least a 10 point difference in RDI scores.
As many as 44 will be enrolled to account for attrition.
Will human subjects be used from the Qatar population?
  Yes   
  No
* If Yes, then approval by an IRB in Qatar may also be required.
 
Will human subjects be used from another international population?
  Yes   
  No
*If Yes, then approval by an international review board or government may also be required.
Will human subjects be used from a Native American population?
  Yes   
  No
*If Yes, then approval by a tribal IRB(s) may also be required.
If Yes for research in Qatar, in another country, or with Native Americans, provide justification for that 
research being conducted in that particular community.
13.2  Provide the age groups being enrolled into this study (Note the consent documents required for each 
 
age group listed in parentheses):  
0-6 (parental consent only, Pediatric Assessment required for Clinical Trials)
7-11 (child’s assent plus parental permission, Pediatric Assessment required for Clinical Trials)
12-17 (consent plus parental permission, Pediatric Assessment required for Clinical Trials)
18+ (consent only)
Enter the specific age range for study population (if overlap or specific within a category):
 

13.3  Indicate the gender of participants being enrolled into this study: 
Male
Female
Both male and female
13.4  Inclusion/Exclusion Criteria
What are the inclusion and exclusion criteria for study participation?
 
Inclusion Criteria
OSA diagnosed adults, at least 18 years old,  who have been recently diagnosed by polysomnography 
(PSG) or polygraphy home sleep test (HST) in the previous year and are currently being treated with 
continuous positive airway pressure (CPAP) having an AHI > 15 events/hour of sleep; two or more OSA 
symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint); at least 8 teeth per arch 
to support either OA device; Mallampati score from I to III; Palatine tonsils – grade 0, 1, or 2;  Central 
and mixed apnea index < 5 events/hour. Consent to study’s timeline;  willingness to wear home sleep 
test apparatus for at least 4 nights and to wear an oral appliance every night for 8 weeks; willingness to 
pick up and return home sleep test kits as needed.
Exclusion Criteria
Cardiac & pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD); central sleep 
apnea; comorbidities of other sleep disorders other than OSA; no active TMD or jaw muscle pain, 
morphological airway abnormalities, BMI ≥35;  pre-existing difficulty swallowing; throat or neck related 
health issues; endocrine dysfunction; severe psychiatric disorders; intellectually disabled; previous OA 
therapy; previous ENT surgery such as uvulopalatopharyngoplasty; restrictions in jaw opening; pregnant / 
breast feeding or intent to become pregnant during the study; inability to provide informed consent and 
apply the HST recorders.
 
Do the exclusion criteria exclude specific populations or individuals based on gender, culture, language, 
economics, race, or ethnicity?
  Yes   
  No
If Yes, then justify each exclusion:
 
13.5  Describe the setting where the informed consent process will take place (e.g. classroom, clinic, 
 
laboratory, office, park, personal computer, etc.).  
If a waiver of documentation of informed consent is requested, then describe how participants will review 
the information sheet.
College of Dentistry clinic.
13.6  Experience of Subjects
Describe the experience of subjects while participating in this research. (Please describe what the 
participant will experience from the time of learning of the study through completion.)
After meeting the study’s inclusion and exclusion criteria through direct or telephone screening, 
prospective participants will receive detailed information about the study from the study coordinator 
during their first appointments. They will have an opportunity to have all of their questions about the 
study answered to their satisfaction by the coordinator and investigators.  Those individuals who give 
informed consent  will be enrolled in the study.  The first appointment to the study center will include 
obtaining a copy of the patient’s polysomnogram/continuous positive air pressure (PSG/CPAP) study 
reports and medical history, completion of the study’s intake assessment. In the absence of a current 
PSG, subjects will be sent home with a HST to collect comparable baseline information.  During this 
approximately 2-hour first appointment, the prospective subject will be given an oral exam by one of the 
team dentists to insure that the dentition, periodontium, temporomandibular joints, muscles of 

mastication are sufficiently healthy and stable for the safe participation in the study. If determined to be 
sufficient, the subject will then be fully enrolled in the study and have the study and tasks explained in 
greater detail. Dental impressions will then be obtained to prepare models for the fabrication of the 
custom oral appliances.  Protrusive bite registrations will also be made at this time.  Both oral appliances 
(OAs) will be constructed prior to the second appointment. During the second appointment, subjects will 
be examined and fitted by one of the study dentists with both OAs; if modifications are needed to improve 
fit, an OA may be sent back to the lab. The subjects will be assigned to one OA or the other at this second 
appointment according to predetermined randomization scheme. Neither the dentist nor the subject will 
know the assignment until the actual delivery.  Subjects will be then scheduled within 4-weeks for the 
first home sleep study (HST, Medibyte system) with simultaneous SleepImage (SI) recording for 
determination of the Relative Disease Index (RDI) and sleep quality criteria. Recordings will occur x1
/subject at T  (first night in week-1 with first OA), T  (after four weeks using first OA), a washout period 
1
2
of 1 week using a mandible repositioner daily and CPAP nightly, T  (first night of week-6 with second OA) 
3
and T  (after four weeks using second OA) (Figure 1; Table 1).
4
 
 
Each participants involvement in the study while at home is as follows:   On each of 4  nights over the 
course of 9 weeks the subject will put on the HST and SI prior to bedtime, and remove them upon 
awakening.  The two systems include attaching sensors to various parts of the face, chest and 
abdomen.    Adhesive pads and surgical tape are used to hold these devices and wires in place. Placement 
may take up to 20 minutes, and removal, about 5 minutes. The coordinator will demonstrate  how to 
apply the sensor properly to insure valid recordings.   Minor discomfort may be experienced when pulling 
off the tape.  If a first night recording is faulty, a subject may be asked to do a second night recording; 
subjects will not be asked to record for more than 8 nights in total. Subjects will wear an OA every night 
for 4 weeks, no OA for the 1-week washout period, and an OA (the alternate device) for each night for 
another 4 weeks.  They will put on the OAs prior to bed and remove them upon awakening.   The OA will 
contain a computer chip that will also record the actual amount of time that the OA is worn each night. 
Subjects use their CPAP devices each night of the washout period as prescribed by their physicians.Some 
discomfort and/or tendeness in the temportomandibular joint (jaw joint or TMJ) and jaw muscles may be 
experienced during and after OA use.  Also some minor tooth movement and discomfort may be 
experienced.  In addition to their OAs, each subject will be given a mandibular repostioner, a small 
custom bite splint to be worn for two minutes after removing the OA upon awakening.  Use of the 
mandibular repostioner will minimize or eliminate the aforementioned discomforts and tooth movement. 
All of this clinical care, potential discomforts and tooth movements will be carefully monitored and 
managed by the dentists on the research team.
 
 
How long will the participants be engaged in the research (length of time, e.g., 15 minutes, 45 minutes 
on Day 1, 60 minutes on Day 2, etc.)?
 
Visit 1: 120 minutes; Visit 2: 60 minutes; Visits 3-9: 15 minutes each. Total in office commitment: 
Approximately 5 hours. For the home sleep tests, approximately 30 minutes for at least 4 nights(but no 
more than 8 nights), for a total of at least 2 hours (but no more than 4 hours)
14.0
 
Privacy and Confidentiality
 
14.1  How will the identities of subjects be protected in all research records? The information collected
 
/analyzed is:  
Note: Data that are coded, where the key to the code is accessible to researchers, are considered 
confidential information and subject to privacy regulations. 
Anonymous: The identity of the participant cannot readily be determined by the investigator AND the 
identity of the participant is not connected to information gathered.
Confidential: Research participants can be identified; however, information gathered will be protected.
Neither: Research participants can be identified, and information gathered may be connected to the 

participant.
Summarize procedures to protect the confidentiality and anonymity of participants (e.g., replies coded, 
etc.).
 
The identities of all subjects will be coded to insure confidentiality as well as the integrity of the data 
analysis.  All data will be stored on encrypted computers of the research coordinator and investigators.
What are the plans for retention and/or destruction of linkages between study data and personal 
identifying information?  (Specify when and how personal identifying information will be destroyed.)
 
Personally identifying data will be destroyed within 3 years of completion of the study, i.e the publication 
of all papers issuing from it.
If these linkages will not be destroyed, explain how you will maintain confidentiality of the personally 
identifying information.
 
If personally identifying information will not be kept confidential, then justify and explain the informed 
consent process for sharing this information.
 
Will a Certificate of Confidentiality (through DHHS or another Federal agency) be utilized?
  https://humansubjects.nih.gov/coc/index
  Yes   
  No
15.0
 
Potentially Sensitive Subject Matter and Procedures
15.1  Will this type of information be collected?
  Yes   
  No
15.2  Select all that describe the information.
No sensitive matters
Abortion
Alcohol
Body composition
Criminal activity
Depression
HIV/AIDS
Learning disability
List of current medications
Medical/dental problems
Medical history
Potential child abuse/neglect
Psychology/psychiatry
Sexual activity
Suicide
Unethical behavior
Other
If other, please specify:
If Medical History or Mental Health History information will be collected, please describe:

15.3  Deception
Will deception be used as part of the study?
  Yes   
  No
If Yes, please describe the deception.
Please describe the debriefing procedures to be used.
Provide justification for the deception.
16.0
 
Risks and Benefits
16.1  Regulatory definition of minimal risk is that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations or tests (45 
CFR 46.102(h)(i)).
Identify the types of risk associated with participation in the study:
Physical
Privacy
Confidentiality
Psychological/emotional
Social
Legal
Other
If Other, please describe the risks:
Describe the potential risks or discomforts to participants. Include justification of the known risks, which 
were selected above.
The minor physical risk associated with the sleep-monitoring aspects of this study are no more than those 
involved with standards test of bodily (physiological) functions, for example wearing a heart monitor. The 
oral appliances are FDA cleared and are in wide use by dental patients throughout the US; they present 
no more risk than that involved in wearing a bite splint to prevent grinding (bruxing) at night, or a 
football player wearing a bite-guard. What makes this experience “research” rather than “routine clinical 
care" is that (1) the participants are randomly assigned to one OA or the other during the two active 
phases of the study, and (2) additional physiological measurements will be made beyond what are 
typically gathered during standard clinical practice. All of these tests are noninvasive.
We do not anticipate any significant physical risk from participating in this study. Though unlikely, some 
subjects may experience itching or rashes from the adhesive hypoallergenic electrodes of the Medibyte or 
the SleepImage devices. There may be minor discomfort upon removing the adhesive pads or surgical 
tape holding them in place, (e.g., pulling out hair with them).  The pulse oximeter may cause some minor 
irrration of the finger or finger nail.
By wearing an OA, a subject may experience some discomfort and/or reduced function of the jaw joint 
(temporomandibular joint) and muscles of the jaw (masticatory muscles) and of the face during and after 
treatment. Subjects may also experience some reduction in sleep quality due to discomfort while getting 
used to wearing the OA (acclimation). Other minor risks include temporary irritation of the mouth and oral 
cavity due to contact with the OA, and excessive salivation or dry mouth from mouth breathing. 
Repositioning of the lower jaw and tooth movement may also occur, but are typically minor and 
reversible.  Also highly unlikely,  a subject could swallow part of an OA should it break.
Describe the approaches you will take to minimize these risks and/or to minimize their impact.

1.  
2.  
3.  
4.  
5.  
6.  
7.  
Participants will be carefully monitored for all of these risks (above) by one or more of the study 
dentists.  The subjects will be able to contact a member of the research team 24/7 to address any 
concerns.
What alternatives are available to subjects outside the research (i.e., what is the standard of care, is the 
research intervention available without participating)?
No alternative treatment options are available as part of this study. If a prospective subject decides that 
either oral appliance therapy is not suitable, the alternative is to not enroll in the study and 
continue  CPAP therapy as prescribed.  Once enrolled in the study, if the subject decides that either oral 
appliance therapy is not suitable at any time, he/she may withdraw from the study and continue with 
CPAP therapy as prescribed.
16.2  What are the potential benefits of this study to individual participants? (This does not include 
payments, compensation, or incentives.)
The benefits of taking part in this study are:
Two customized oral appliances are yours to keep upon completion of the study at no cost to you
Effective devices that do not require electricity to operate, so can be used anywhere
Reduced apnea and snoring
Improved sleep quality and continuity
An effective treatment for obstructive sleep apnea that does not require wearing a face mask
No air pressure blowing through your nose
Receiving information on your sleep quality.
The researchers or study coordinator will discuss with you possible options that might be of benefit to you 
if a sleep issue is discovered.
 
 
 
16.3  What are the potential benefits of this study to the population or society?
The findings will provide objective evidence for consumers regarding the comparative effectiveness of oral 
appliance for treating snoring and sleep apnea.  It will also establish baselineline data for future studies 
on the treatment of sleep disordered breathing in high risk populations such as (1) pregnant women, (2) 
academically underperforming school children, and (3) adults with atrial fibrillation.  Additionally, it may 
lead to a widely usuable method of studying disordered sleep and its treatment that is both simple and 
cost-effective.
17.0
 
Personally Identifiable Information
17.1  Indicate which of the following personally identifiable information (PII) will be accessed or recorded 
 
in association with this study:
None
Name
Web addresses (URLs)
Full Face Photographic Image
Internet IP Address
Health Plan Beneficiary Number
Certificate/ License Number
Any Other Unique Identifier or Combination
Geographic Information (including city and ZIP)
Vehicle Identification Number and Serial Numbers Including License Plate Number
Telephone Number
Email address
Fax number
Social Security Number

Medical Record Number
Account Number
Medical Device Identifiers
Biometric Identifiers
Dates directly related to an individual (including birth, death, admission, discharge, date of procedure)
Educational Records
Will any PII in your possession be coded?
 Yes   
 No
Will you have the code in your possession?
 Yes   
 No
Is this personally identifiable information considered Protected Health Information (PHI)? (PHI is any of 
the 18 identifiers listed above collected by or received by a covered entity, which includes a healthcare 
provider, healthcare clearing house, or as defined in the Univeristy SAP 16.99.99.M0.01.)
 Yes   
 No
*If Yes, additional requirements may be involved such as HIPAA authorization, Waiver of 
Authorization, or Data Use Agreement, or other agreements.
17.2  Explain why you need to obtain personally identifiable information (list all of the data fields to be 
 
collected):  
Phone numbers, email addresses and physical addresses are needed to communicate with participants 
over the duration of the 9 week study.  Diagnostic devices (home sleep test kits and their components 
such as batteries) will be sent back and forth between participants and study personnel as needed, such 
that addresses must be kept. Social security numbers may be needed to monetarily compensate subjects. 
Medical device numbers (sleep recorders) as well as the date/time of recordings will be recorded to insure 
the integrity of the sleep study data.
The identity of the subjects, as well as to which group they have been assigned will be coded to insure the 
integrity of the data analysis: the analysist will be "blinded" in this regard.
17.3  Does this study involve use of Protected Health Information (PHI) being received from a Covered 
Entity (e.g. healthcare provider, healthcare clearing house, health plan)?
 Yes   
 No
Will the provider be a collaborator on this study who will maintain the code to the PHI in their possession?
  Yes   
  No
If yes, identify the covered entity and provide the data use agreement or business associate agreement.
Version
Title
Category
Expiration 
Date
Document 
Outcome
Checked Out
View 
Document
No Document(s) have been attached to this form.
Covered Entity:
Does this study involve collection of PHI from participants or receipt of PHI from a covered entity?
 Yes   
 No
Does this study involve distribution of PHI to a Covered Entity (e.g. healthcare provider, healthcare 
clearing house, health plan)?
  Yes   
  No

If Yes to any of these three previous questions, PHI authorization or a waiver of PHI authorization is 
required. Is a waiver of PHI authorization being requested? For more information, see the additional 
information online: http://rcb.tamu.edu/humansubjects/resources/consentinfo
  Yes   
  No
Please attach the HIPAA Authorization as needed to the application.
Version
Title
Category
Expiration 
Date
Document 
Outcome
Checked Out
View 
Document
No Document(s) have been attached to this form.
17.4  Will the PHI used in this study be stored with encryption?
 Yes   
 No
How is PHI  transmitted electronically being protected?
It will be sent in encrypted format. All computers used by the research team will have Bitlocker encryption 
on them.
How is PHI data protected?
The only PHI to be transmitted to the two companies reading the sleep studies are the dates, times, city 
and coded subject identities; these companies will be unable to link data to individuals.
Who has access to PHI?
Only the research team at the Texas A&M College of Dentistry.
18.0
 
Retrospective Details (Please note: This refers to the analysis of data, 
documents, records, or specimens that were existing as of the date of 
the IRB application.)
18.1  Will existing data or documents be used (e.g., patient records/charts, samples/specimens, public 
records, surveys, evaluation tools, etc.)?
 
NOTE:  If you answer NO to this question, please skip the remaining questions in this section.  
 Yes   
 No
If Yes, then:
Describe the data or documents that will be used.
Medical history including sleep apnea diagnosis, list of medications and polysomnogram/continuous 
positive air pressure (PSG/CPAP) study reports,
What is the date range of the original data collection?
No more than 3 years prior to enrollment and until the end of the proposed study.
How will the existing data be obtained? Additional information may be required to establish authority to 
use the data previously collected.
Patients will authorize the release of their medical history, polysomnogram/continuous positive air 
pressure (PSG/CPAP) study reports, and sleep apnea diagnoses from their physicians. This information 
will be obtained in paper forms or via encrypted electronic communication.
18.2  
 
Will your research be limited to 
 existing data or specimens?
only
NOTE:  If data/specimens will be 
collected after submission of this application, then the answer here is "No". If you answered NO to 
 
this question and the main question above, please skip the remaining questions in this section.  
 Yes   
 No

18.3  Will existing specimens be used (e.g., human blood, tissue, saliva, etc.)?      
  Yes   
  No
If Yes, then describe the specimens that will be used and how they will be obtained.
Indicate the number of specimens.
How will the specimens be obtained?
Provide the documentation from the holder of the samples that gives you permission to use the samples 
for research purposes. If the samples were collected for research purposes, provide a copy of the 
approved informed consent document used to obtain the samples.
 
 
18.4  Retrospective Details – Publicly Available
Is the source of the data for your research accessible by the general public?
  Yes   
  No
Provide the link if applicable.
18.5  Retrospective Details – Identity
Will it be possible to determine a subject’s identity directly or indirectly through a link (e.g., Medical 
Record Number (MRN), participant code, IP address, email)?
 Yes   
 No
18.6  Retrospective Details – Waiver of Informed Consent
Is it impractical to obtain informed consent from the subjects?
  Yes   
  No
If Yes, then please complete the Waiver of Informed Consent information in the next section.
18.7  Retrospective Details - Waiver of Document of Informed Consent
Is it possible to obtain informed consent, AND the only link between the data and the human subject 
would be the signed informed consent document?
  Yes   
  No
19.0
 
Data Management
 
19.1  
 
General Information  

STANDARD ADMINISTRATIVE PROCEDURE
15.99.03.M1.03 The Responsible Stewardship of Research Data
http://rules-saps.tamu.edu/PDFs/15.99.03.M1.03.pdf
 
 Do you agree to adhere to the SAP with your data?
 Yes   
 No
Where will the data be stored? Indicate building and room number on TAMU property.
Main College of Dentistry building at 3302 Gaston Avenue, Room 499.
How long will the data be stored? (Note: This time period should be a minimum of 3 years post 
completion of the research and perhaps longer, depending on sponsor requirements.)
 
For 3 years after completion.
If you are storing or transmitting collected data, is the storage and transmission of the data encrypted?
 Yes   
 No
Please note that PHI must be stored and transmitted with encryption.
Who will have access to the data?
 
The research team.
19.2  Data Safety Monitoring Plan
 Yes   
 No
If so, then:
            How is it managed?
 
With what frequency is data reviewed for this project?
How often does the DSMB meet?
What is the frequency of reports from the DSMB?
Describe any planned interim analysis.
Provide names, affiliations, and qualifications of members.
 
It is managed through the Post Approval Managing Process.
20.0
 
Informed Consent
20.1  
 
Select all that apply and attach to the application:  
For templates and guidance regarding informed consent, see http://rcb.tamu.edu/humansubjects
/resources/consentinfo
Informed Consent Document (signed consent, typically needed in Texas for research involving adults)
Parent Informed Consent Document
Parent Permission Form
Assent Form (typically needed in Texas for research involving children under 18)
Recruitment Script (verbal)
Recruitment Email
Information Sheet (also select Waiver of Documentation of Informed Consent)

Waiver of Informed Consent
Waiver of Documentation of Informed Consent
Other
If other, please specify:
Recruitment flyers posted at the College of Dentistry, Dallas A.W.A.K.E. office (support group for sleep 
apnea patients) and Dallas area sleep clinics. Online postings at clinicaltrials.gov and the College web site. 
Also post flyers at (1) regional hospitals and clinics, (2) city and county offices/stations (such as the 
Dallas Fire Department), (3) DART and other transportation offices and (4) Facebook, Twitter and similar 
site, (5) local newspapers and magazines, (6) local radio stations. The content of the advertisements on 
venues (5) and (6) will be the same as the approved flyers. Written permission will be sought from all 
sites at which flyers are to be posted.
20.2  Please provide the readability statistics for each informed consent document in terms of the Flesch-
Kincaid Grade Level. In general, informed consent document for adults should be on an 8th grade 
level.
http://rcb.tamu.edu/humansubjects/resources/tipsconsentforms
This is currently at the 10.8 level.   
20.3  Please describe the informed consent process. Include how participants will be adequately informed 
of what they will be asked to do in the study as well as how they will be protected. Include how the 
forms selected above will be used in the process including that the particpants will have sufficient 
time to review any information provided to them.
If a waiver of documentation of informed consent is requested, then the information sheet use must be 
described here.
Those interested in participating will discuss over the phone, via email or meet in person with the 
research coordinator (RC) at the College of Dentistry clinic.   The Informed Consent Document (ICD) will 
be made available. The RC will determine eligibilty with regard to inclusion/exclusion criteria, as well as 
having a current sleep apnea diagnosis and polysomnogram.  If eligible, The RC will then explain in detail 
the procedures, risks, benefits, compensation and time commitment involved in the study.  The RC will 
ask the prospective subject (PS) to repeat his/her understanding of the study, their involvement, and 
especially risks and benefits. The PS will be given the opportunity to speak with the the principal 
investigator or other investigators on the team to futher discuss the study. The PS will also have the 
opportunity to take home the ICD and discuss it with family and friends.  Once the PS indicates that all 
questions have been answered to his/her satisfaction, he/she may sign the informed consent document to 
enroll.  The PS will be given a copy of the signed document.
The recruitment documents listed above will notify prospective subjects of the opportunity to participate 
and will contain the contact informtion for the RC. The bulk email will give a very brief overview of the 
study and provide a link to a detailed description.
20.4  
 
Where will the informed consent process take place (e.g. building name, physical address)?  
Where will the informed consent documents be physically stored?
In Room 499 at 3302 Gaston Avenue. In top drawer of horizontal file cabinet.
Who will have access to the Informed Consent documents?
The principal investigator and the research coordinator.
20.5  For studies involving research on children, will participants who reach age of majority be consented?
  Yes   
  No
20.6  Have the PI, Co-I(s), and any persons interacting with study subjects completed CITI training?

 Yes   
 No
If No is selected, have the PI, Co-I(s), and any persons interacting with study subjects completed 
alternative human subjects training? If so, please provide a description and copy of the alternative 
training.
 
20.7  Please indicate the research personnel who will be obtaining informed consent from participants. 
(Use N/A to indicate that informed consent will not be collected.)
Emet D. Schneiderman
Steven D. Bender
Jason Hui
P. Duane Wilson
Clinical Research Coordinator : Zohre German
Preetam J. Schramm
20.8  What project-specific training/experience have individuals obtaining informed consent received (e.g. 
 
verbal instruction by the PI, practice with the PI)?  
Verbal instruction and practice with the PI.  Use of a script when explaining the two arms of the study to 
minimize bias and to maintain equipoise.
20.9  Will the subject have the opportunity to review the informed consent document or Information 
Sheet, ask questions, and understand the details of the study prior to participation?
 Yes   
 No
If Yes, then how much time will be provided?
 
As much time as needed.
20.10  
 
How will cultural issues, including language, be addressed?  
At this time participants must be fluent in English, both spoken and written.  Should there be sufficient 
interest in participating by another language group,  a bilingual staff member will be enlisted and 
translated versions of all of the forms and questionnaires will be added.
20.11  Will non-English speaking people be approached to participate in this study?
  Yes   
  No
Will a translation be available for non-English speaking subjects?
Verbally (provide script)
In writing (provide documents)
Both

Neither
20.12  If the study involves minors, then describe the informed consent process of parental permission 
 
and how the assent of the minor will be sought. Attach the documents to the application.  
21.0
 
For Biomedical Research
21.1  Select all that apply to the study:
Retrospective (data/specimens available at the time of this application)
Prospective (data/specimens to be collected after IRB approval)
Randomized
Double-blind
Single-blind
Unblinded (open label)
Placebo-controlled
Therapy/Intervention/Prevention
Pilot or Feasibility Study
Diagnosis or Diagnostic Test
Etiology/Harm/Risk Factors (incl Molecular Genetics)/Mechanism of Disease
Prognosis
Descriptive or Prevalence
Device
Drug
Other
If other, please specify:
What is the disease or condition being studied?
Snoring and obstructive sleep apnea; unstable/poor sleep quality
Is your project evaluating an active intervention or treatment procedure (to determine whether an 
intervention/treatment is effective for the people undergoing it)?
 Yes   
 No
Please provide a justification for conducting this research in humans rather than animals.
 
This is a comparative effectiveness study on two widely used therapies for obstructive sleep apnea in 
humans.   It is evaluating how they perform clinically, that is, in living humans, so that animal 
studies would be inappropriate. Also, this study must be done on humans because of the subjective 
aspects of (1) the human sleep experience, (2) the fit and comfort of the oral appliances; these cannot be 
evaluated in animals. All of the devices being evaluated in this study, both therapeutic and diagnositic 
have been designed for humans, and are cleared for human use. Comparative compliance will also be 
evaluated, which also is a strictly human behavior issue.
Does this study involve genomic data?
  Yes   
  No
If yes, will the genomic data be shared?
  Yes   
  No
Version
Title
Category
Expiration 
Date
Document 
Outcome
Checked Out
View 
Document
No Document(s) have been attached to this form.

If yes, please indentify the recipients and provide the Genomic Data Sharing Certification as required by 
NIH
(
).
http://gds.nih.gov/03policy2.html
22.0
 
Reporting
22.1  Clinical trials, both therapeutic and observational, may require reporting.
Please indicate where this study will be reported.
ClinicalTrials.gov
National Cancer Institute (NCI)
Other, please indicate below
23.0
 
Drugs, Biologics, Devices, and Dietary Supplements
23.1  Indicate if this project involves the study of any of the following:
Drug
Biologic
Device
Dietary supplement (if the research is intended to evaluate the supplement’s ability to diagnose, cure, 
mitigate, treat, or prevent a disease, then select DRUG)
Not applicable
24.0
 
Use of Study Drugs
24.1  Will drugs be used in this study?
  Yes   
  No
If yes, then is this study being conducted under an approved IND or drugs already approval and being 
used in accordance with the label?
  Yes   
  No
If so, then who is the responsible physician? Include affiliation and contact information.
Include information concerning the intervention/treatment of participants and a description of the 
procedures being performed already for diagnostic or treatment purposes.
Attach the Investigator’s Brochure to the application and indicate the version date.
24.2  Study Drug Details
Just below this line, add a row to begin the IRB Study Drug form. Complete one row per drug.

25.0
 
Medical Devices
25.1  Will medical devices be used in this study?
 Yes   
 No
If using a device, then is this study being conducted under an approved IDE or HDE or already approved 
device used in accordance with the label?
  Yes   
  No
If so, then who is the responsible physician? Include affiliation and contact information.
Steven D. Bender, DDS
Include information concerning the intervention/treatment of participants and a description of the 
procedures being performed already for diagnostic or treatment purposes.
What measurements are to be conducted?
Braebon Medibyte: airflow, respiratory effort and blood oxygenation; apnea & hypopnea detection; 
respiratory effort using inductance plesthysmogrphy.
SleepImage M1: electrocardiogram (ECG), actigraphy, snoring, and body position; cardiopulmonary 
coupling.
Attach the device manual to the application and indicate the version date.
 
25.2  
 
List the medical device(s) to be used:  
Provide the following information:
Device name: Manufacturer/supplier of device: Where will the devices be stored? Will devices be supplied 
at no cost? Yes No Is this a HUD (HDE)? Yes No HDE number: FDA approved: A new device or a new used 
of approved device? Yes No IDE necessary? Yes No IDE number: Who holds the IDE? IDE details: Device 
level of risk: How will access be controlled? How will the device be used? How will the device be 
destroyed and disposed? Alternatives available to patients:
Home sleep test systems (HSTs; diagnostic)
Medibyte, Braebon Medical, Kanata, Ontario, Canada.
SleepImage home sleep test device, SleepImage, Broomfield Colorado, USA.
 
Oral appliances (OAs; therapeutic)
TAP 1,   Airway Management, Inc., Dallas, Texas.
SomnoDent Flex, SomnoMed, Plano, TX
 
 
Where will the devices be stored? Room 499
Will devices be supplied at no cost? Yes, however a refundable deposit  will be required.
Is this a HUD (HDE)?No
HDE number: NA
FDA approved: Yes, all are FDA cleared
A new device or a new used of approved device? No
IDE necessary? No
IDE number: NA
Who holds the IDE? NA
IDE details: NA
Device level of risk: No more than minimal

1.  
2.  
3.  
4.  
5.  
6.  
How will access be controlled? The research coordinator will issue (check-out) and retrieve (check-
in) the HST devices following outlined procedures the day before and after 1 night of sleep 
recording. The OAs will be issued in randomized order at the beginning of each 4-week testing 
period. Subjects are allowed to retain the OA indefinitely for their use after the study.
How will the device be used?Each of the test custom-fitted OAs will be worn each night during 
sleep for a 4-week period with a 1-week washout period between test OAs. The subject is expected 
to wear their prescribed CPAP during the washout period. The HST recorders to evaluate sleep 
quality with OA use will be obtained by study subjects for each of the two OA testing periods on 
the first and last day of each 4-week period. A total of 4 sleep recordings/subject is expected over 
the 9-week study period.
How will the device be destroyed and disposed? The HST recorders are reusable/non-disposable 
items, so they will not be destroyed.
Alternatives available to patients: No alternative treatment options are directly part of this study. 
If a prospective subject decides that either oral appliance therapy is not suitable for him/her, the 
alternative is to continue to use his/her prescribed CPAP therapy.
26.0
 
Before you Submit
26.1  Please note the following.
The following checklist is a guide for researchers regarding supporting documents that must be 
considered for and/or uploaded with this application for review and approval before use.
Informed Consent Document
Information Sheet
Waiver of HIPAA Authorization
Parental Permission Form/Minor Assent Form
Recruitment materials (i.e. flyers, emails, advertisements, telephone scripts, social media posts)
Site Authorization Letter (for study conduct and/or access to administrative records)
Survey/Questionnaire/Data Collection/Abstraction Forms
Grant Applications (cover to cover), required if funded or grant submitted
Instructions
Protocol Investigator’s Brochure (for clinical trials only)
Case report form (for clinical trials only)
Device Manual (if using an approved or investigational device)
Thesis/dissertation proposal
Waiver of parental permission/minor assent form
Letter of cultural evaluation for international research (link to SOP)
IRB approvals from collaborating institutions
Any other documents related to the research
CVs for all investigators when proposed activities are more than minimal risk
CITI training for all personnel
 
Investigators assume the following responsibilities:
Continuing Review: The study must be renewed by the expiration date in order to continue with 
the research. A Continuing Review application along with required documents must be submitted 
by the continuing review deadline. Failure to do so may result in processing delays, study 
expiration, and/or loss of funding.
Completion Report: Upon completion of the research study (including data collection and 
analysis), a Completion Report must be submitted to the IRB.
Unanticipated Problems and Adverse Events: Unanticipated problems and adverse events 
must be reported to the IRB immediately.
Reports of Potential Non-compliance: Potential non-compliance, including deviations from 
protocol and violations, must be reported to the IRB office immediately.
Amendments: Changes to the protocol and/or study documents must be requested by submitting 
an Amendment to the IRB for review. The Amendment must be approved by the IRB before being 
implemented.
Consent Forms: When using a consent form or information sheet, the IRB stamped approved 
version must be used. Please log into iRIS to download the stamped approved version of the 

7.  
8.  
9.  
10.  
11.  
12.  
consenting instruments. If you are unable to locate the stamped version in iRIS, please contact 
the iRIS Support Team at 979.845.4969 or the IRB liaison assigned to your area. Human 
participants are to receive a copy of the consent document, if appropriate.
Post Approval Monitoring: Expedited and full board studies may be subject to post approval 
monitoring. During the life of the study, please review and document study progress using the PI 
self-assessment found on the RCB website as a method of preparation for the potential review. 
Investigators are responsible for maintaining complete and accurate study records and making 
them available for post approval monitoring. Investigators are encouraged to request a pre-
initiation site visit with the Post Approval Monitor. These visits are designed to help ensure that all 
necessary documents are approved and in order prior to initiating the study and to help 
investigators maintain compliance.
Recruitment: All approved recruitment materials will be stamped electronically by the HRPP staff 
and available for download from iRIS.  These IRB-stamped approved documents from iRIS must 
be used for recruitment.  For materials that are distributed to potential participants electronically 
and for which you can only feasibly use the approved text rather than the stamped document, the 
study’s IRB Study Number, approval date, and expiration dates must be included in the following 
format: TAMU IRB#20XX-XXXX  Approved: XX/XX/XXXX  Expiration Date: XX/XX/XXXX.
FERPA and PPRA: Investigators conducting research with students must have appropriate 
approvals from the FERPA administrator at the institution where the research will be conducted in 
accordance with the Family Education Rights and Privacy Act (FERPA). The Protection of Pupil 
Rights Amendment (PPRA) protects the rights of parents in students ensuring that written parental 
consent is required for participation in surveys, analysis, or evaluation that ask questions falling 
into categories of protected information.
Food: Any use of food in the conduct of human research must follow Texas A&M University 
Standard Administrative Procedure 24.01.01.M4.02.
Payments: Any use of payments to human research participants must follow Texas A&M 
University Standard Administrative Procedure 21.01.99.M0.03.
Records Retention: Federal Regulations require records be retained for at least 3 years after 
study closure. Records of a study that collects protected health information are required to be 
retained for at least 6 years after study closure. Some sponsors require extended records 
retention. Texas A&M University rule 15.99.03.M1.03 Responsible Stewardship of Research Data 
requires that research records be retained on Texas A&M property.
 
Post-approval monitoring requires that key study personnel have access to study materials.