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Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep Apnea

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Abstract Background: Custom oral appliances that adjustably advance the mandible provide superior outcomes when treating patients with moderate or severe sleep apnea. Custom appliances, however, are expensive, must be fitted by a dentist, and the likelihood of successful outcomes are difficult to predict. An inexpensive trial appliance, if proven efficacious, might be used to predict custom appliance outcomes or to provide temporary therapeutic benefit. Objective: The aim of this initial study was to assess the treatment efficacy of a novel titration oral appliance with that of an optimized custom appliance. Methods: Seventeen patients, treated with a custom oral appliance for at least one year, successfully completed a three-night home sleep test. The baseline obstructive sleep apnea severity was established on Night 1 with seven patients exhibiting severe, six moderate and four mild apnea/hypopnea indexes. Patients were randomly assigned to wear their custom appliance or the titration appliance on Nights 2 and 3. Results: Significant reductions in the mean overall and supine apnea indexes (p < 0.05), and the overall (p < 0.01) and supine (p < 0.05) apnea/hypopnea indexes were observed for both the titration and custom appliances. The proportion of patients who exhibited at least a 50% reduction in the overall apnea index and supine apnea/hypopnea were similar for the titration and custom appliance (~60%). The custom appliance reduced the overall apnea/hypopnea index by 50% in a greater proportion of the patients compared to the titration appliance (77% vs. 53%). The titration appliance significantly reduced the degree of hypoxic exposure across sleep disordered breathing events overall (p <0.05) and supine (p < 0.01). Patients found their custom appliance was more comfortable than the titration appliance, but preferred the titration appliance to no therapy. Conclusion: The titration appliance may be useful in assessing oral appliance treatment efficacy. When set to 70% of maximum protrusion, the titration appliance may provide immediate, temporary therapeutic benefit.
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ISSN:
Journal of Sleep Disorders & Therapy
The International Open Access
Journal of Sleep Disorders & Therapy
Executive Editors
Daniel Zelterman
Yale University, USA
Lawrence Michael McGlynn
Stanford University School of Medicine, USA
Robert H. Howland
University of Pittsburgh Medical Center, USA
Wun Jung Kim
University of Pittsburgh, USA
Leila Kheirandish-Gozal
The University of Chicago, USA
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Digital Object Identi er: http://dx.doi.org/10.4172/jsdt.1000101
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
Sleep Disorders & Therapy
Levendowski et al. J Sleep Disord Ther 2011, 1:1
http://dx.doi.org/10.4172/jsdt.1000101
Research Article Open Access
Initial Evaluation of a Titration Appliance for Temporary Treatment of
Obstructive Sleep Apnea
Daniel J. Levendowski1*, Todd Morgan2 and Philip Westbrook1
1Advanced Brain Monitoring Inc., Carlsbad, USA
2Scripps Dental Group, Carlsbad, USA
Abstract
Background: Custom oral appliances that adjustably advance the mandible provide superior outcomes when
treating patients with moderate or severe sleep apnea. Custom appliances, however, are expensive, must be tted
by a dentist, and the likelihood of successful outcomes are difcult to predict. An inexpensive trial appliance, if proven
efcacious, might be used to predict custom appliance outcomes or to provide temporary therapeutic benet.
Objective: The aim of this initial study was to assess the treatment efcacy of a novel titration oral appliance with
that of an optimized custom appliance.
Methods: Seventeen patients, treated with a custom oral appliance for at least one year, successfully completed
a three-night home sleep test. The baseline obstructive sleep apnea severity was established on Night 1 with seven
patients exhibiting severe, six moderate and four mild apnea/hypopnea indexes. Patients were randomly assigned to
wear their custom appliance or the titration appliance on Nights 2 and 3.
Results: Signicant reductions in the mean overall and supine apnea indexes (p < 0.05), and the overall (p <
0.01) and supine (p < 0.05) apnea/hypopnea indexes were observed for both the titration and custom appliances. The
proportion of patients who exhibited at least a 50% reduction in the overall apnea index and supine apnea/hypopnea
were similar for the titration and custom appliance (~60%). The custom appliance reduced the overall apnea/hypopnea
index by 50% in a greater proportion of the patients compared to the titration appliance (77% vs. 53%). The titration
appliance signicantly reduced the degree of hypoxic exposure across sleep disordered breathing events overall (p <
0.05) and supine (p < 0.01). Patients found their custom appliance was more comfortable than the titration appliance,
but preferred the titration appliance to no therapy.
Conclusion: The titration appliance may be useful in assessing oral appliance treatment efcacy. When set to
70% of maximum protrusion, the titration appliance may provide immediate, temporary therapeutic benet.
*Corresponding author: Daniel J. Levendowski, Advanced Brain Monitoring Inc.,
2237 Faraday Avenue, Suite, 100, Carlsbad, CA 92008, USA, Tel: 1-760-720-0099;
Fax: 760-476-3620; E-mail: Dan@b-alert.com
Received December 13, 2011; Accepted December 18, 2011; Published
December 24, 2011
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a
Titration Appliance for Temporary Treatment of Obstructive Sleep Apnea. J Sleep
Disord Ther 1:101. doi:10.4172/jsdt.1000101
Copyright: © 2011 Levendowski DJ, et al. This is an open-access article
distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided
the original author and source are credited.
Keywords: Obstructive sleep apnea; Oral appliance therapy;
Titration; Mandibular repositioning; Splint
Introduction
Oral appliance therapy (OAT) has been demonstrated to be
ecacious in the treatment of Obstructive Sleep Apnea (OSA) [1-3].
Reports suggest that long-term OAT compliance is high [4], and the
dental eects are mild [5]. When properly titrated, OAT provides
similar outcomes as continuous positive airway pressure in patients
with mild/moderate OSA both short [6] and long-term [7]. Custom
appliances, as compared to non-adjustable devices, are more likely to
provide successful therapy in patients with moderate-severe OSA [8].
To fabricate a customized appliance, a dentist makes impressions and a
bite registration of the patient’s upper and lower teeth. A George gauge
is typically used to determine the relationship between the upper and
lower dental arches in the neutral and maximum voluntary protrusive
settings in order to select an initial protrusive jaw position. A dental
laboratory uses the impressions to make castings, and then fabricates
the custom appliance using materials that provide two or more years
of useful life, articulated to the prescribed protrusive setting. Once the
appliance is delivered to the patient, further adjustments are made until
the mandible is optimally protruded and symptoms resolve. Depending
on the mechanism used for the appliance, sub-millimeter protrusion
adjustments are possible. e assessment of treatment ecacy and/or
need for further adjustment is typically made with a home sleep test(s)
[2,3]. Alternatively, the optimized appliance setting can be determined
with the assistance of a technician during an attended sleep study [1,
8,9].
Studies have shown that not all patients with OSA respond to OAT.
e primary factors that impacts therapeutic success are the appliance
settings, including: protrusion, vertical separation of the dental arches,
and freedom for vertical and lateral movement [10,11]. However, the
ratio of the frequency of apneas to hypopneas, the positional inuence
on AHI severity, the neck circumference, and the body mass index can
also contribute to poor outcomes [2]. Given this uncertainty about
the ecacy in any given patient, and given that the cost for delivery
of a custom appliance (which many patients must pay for) is between
$2,000-$3,000, physicians can be reluctant to refer for a trial of OAT.
Dentists, clinicians and patients would all benet from an inexpensive
trial appliance that could be easily tted, and most importantly, could
reliably predict ecacy. If proven ecacious, the appliance could also
be used as a temporary appliance when required (e.g., manage OSA
severity perioperatively).
is report is based on an initial evaluation of the ecacy of an
inexpensive titration appliance, easily tted in 15-minutes by any
properly trained healthcare professional, for use in determining a
patient’s response to oral appliance therapy or to provide immediate
temporary therapy.
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 2 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
Materials and Methods
Twenty subjects were enrolled aer obtaining an informed consent
(approved by the BioMed IRB, San Diego, CA, USA). Criteria for
inclusion included: 1) Completion of a baseline ARESTM (ARES
Medical, Carlsbad, CA) home sleep test with an apnea/hypopnea
index greater than 10 events per hour, 2) Being tted with either a Tap
III (Airway Labs, Dallas, Tx) or Herbst (Great Lakes Orthodontics,
Tonawanda, New York) custom mandibular repositioning device, 3)
Completed multi-night home sleep tests used to select the optimal
protrusion setting, and 4) Continuously wearing the same custom
appliance for greater than one year.
Subjects were expected to complete a three-night ARES sleep study
with a minimum of ve hours of recording time per night. One subject
was inadvertently studied and then dropped because he had replaced
the custom appliance required for the study. Two subjects were unable
to successfully complete the night’s sleep with the titration appliance.
ose included for analysis were12 males and ve females, with a mean
age of 58 + 9.0 SD (range 34 to 69) years, BMI of 28 + 4.4 SD (range
19 to 37) kg/m2, and neck circumference of 41 + 4.4 SD (range 34 to
48) cm.
e baseline obstructive sleep apnea severity was established
on Night 1 when no appliance was worn. To minimize risk to the
patient (given the OSA severity of those recruited), the protocol did
not include a wash-out period to eliminate possible carry-over benet
from treatment. For Nights 2 and 3, subjects were randomly assigned
to wear either their custom appliance or a titration appliance set to
70% of maximum voluntary protrusion. Ten subjects who successfully
completed the overnight studies wore the Tap III and seven wore
the Herbst appliance. Aer the three night study, patients completed
a survey to compare the comfort and sleep quality with custom vs.
titration appliances vs. no appliance.
Sleep disordered breathing severity outcome measures from the
sleep studies were derived using the ARES auto-scoring algorithms.
e description and accuracy of this device as compared to laboratory
polysomnography has been previously reported [12-16]. e primary
outcome measures stratied by night included the apnea index (i.e.,
> 10-second cessation in airow) and apnea/hypopnea index with a
4% oxyhemoglobin desaturation (AHI-4%) by and across positions,
percentage of sleep time with snoring greater than 30, 40 or 50 dB, and
the average reduction in SpO2 across all events with a 50% reduction
and recovery in tidal volume.
e titration appliance used in this study was the Apnea Guard®
(Advanced Brain Monitoring, Carlsbad, CA) (Figure 1). e upper
and lower trays expand to accommodate a full range of arch widths.
e tethered locking mechanism provides one millimeter adjustments
across protrusive ranges from 8 mm retrognathic to 18 mm prognathic.
Standard dental impression material is used to provide denture
retention. e size (High) was used in this study provided 8 mm of
anterior and 6 mm of posterior vertical dimension of occlusion.
Posterior posts provide bite support for patients with bruxism.
Prototype appliances were used in this study; the device has been
subsequently approved for up to 30-nights of use.
A systematic approach was employed to measure the optimal
amount of retention material and prepare the appliance. A specic
amount of retention material is measured for the upper and lower trays.
Beginning with the lower tray, the teeth are tted with the retention
material. A recommended sequence for tting the lower and upper
trays ensures the retention material provides protection for all of the
teeth. Once the retention material is tted, the neutral and maximum
voluntary protrusions are determined with the titration appliance
inserted. e neutral (column) and maximum (row) values are applied
to the work table (Figure 2) to derive the setting that corresponds to
a 70% of maximum protrusion. e work table presents protrusion
settings in 0.5 mm increments to accurately reect 70% protrusion;
however the appliance provides allows 1 mm incremental adjustments.
In this study, protrusions setting were rounded up to the nearest integer
value because patients were accustomed sleeping with an advanced
mandible position. e appliance is designed so the neutral, maximum
and 70% settings can be recorded on the device for future reference.
To assess how closely the 70% protrusion of the temporary
appliance matched the protrusive setting for the custom appliance,
marks were made on the upper and lower trays at the anterior aspect of
the rst molar. Calipers were used to measure the distance between the
marks. e neutral and maximum voluntary protrusion were measured
with both the titration appliance and a George gauge for subsequent
comparison. Measures were repeated three times to assess reliability.
Given the expected directional change resulting from initiation of
therapy, one-tailed t-tests were used to assess statistically signicant
changes in OSA severity between baseline vs. the titration or custom
oral appliance.
Results
No dierences were observed in the mean overall, supine or non-
supine valid sleep times. A minimum of 18 minutes of valid sleep time
Figure 1: Temporary appliance with a) side view with lock covered, b) top
view with lock in place and c) adjustment numbers locking holes, and location
to record the titration measurements.
Figure 2: Work table used to determine 70% maximum protrusion based on
neutral (column) and maximum voluntary protrusive (row) settings.
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 3 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
was required to derive positional OSA severity values. Two patients
slept exclusively supine during the baseline test, and one patient slept
supine across all three nights. Insucient supine time was observed in
two patients with the titration appliance and one patient with custom
appliance.
e mean overall, supine and non-supine apnea index values are
presented in (Figure 3) at baseline and with the titration and custom
appliance. Seven patients exhibited severe (AHI > 30), six moderate
(AHI 15 – 29) and four mild (AHI < 15) OSA. Changes in the mean
overall values were signicant for both the titration and custom
appliances (p = 0.022 and 0.027 respectively). e minimum estimated
reduction that would be expected based on the low condence interval
(L-CI) was 2 apneas/hr for the titration appliance and 1 apnea/hr for
the custom appliance. Signicant changes were also observed in the
supine apnea index for the titration and custom appliances (p = 0.035
and 0.006, L-CI = 1 and 6 events/hr, respectively). e percentage of
patients with a baseline overall apnea index > 5 that showed at least a
50% reduction was 60% for the titration appliance (9 of 15) and 64% for
the custom appliance (9 of 14).
e mean overall, supine and non-supine apnea/hypopnea index
values are presented in (Figure 4) at baseline and with the titration
and custom appliances. Signicant reductions in the mean values
were observed for both the titration and custom appliances overall (p
= 0.009 and 0.005, L-CI = 4 and 5 events/hr) and supine (p = 0.027
and 0.002, L-CI = 4 and 9 events/hr). Changes from baseline for
individual cases were stratied by severe (AHI > 30) and moderate/
mild OSA and presented for the overall AHI (Figure 5), supine AHI
(Figure 7) and non-supine AHI (Figure 9). At least a 50% reduction
in overall AHI was observed in 53% (9 of 17) of the patients with the
titration appliance and 77% of those with the custom appliance (13
of 17). Comparisons of the percent change stratied by OSA severity
are presented in (Figure 6). e proportion of patients with at least a
50% reduction in a measurable supine AHI was 67% (10 of 15) with
the titration appliance and 63% (10 of 16) with the custom appliances.
Dierences in the percentage change in supine AHI from baseline are
presented in (Figure 8).
Signicant reductions in SpO2 reductions across sleep disordered
breathing events were obtained with the titration appliance overall and
supine (Figure 10) (p=0.014 and 0.006, L-CI = 0.3 and 0.5 % reduction
in SpO2). e eect of the custom appliance on the reduction in SpO2
desaturation was close to signicant overall and supine (p = 0.058 and
0.055). Individual cases, stratied by OSA severity overall and in the
supine position are presented in (Figures 11 and 12).
e percentage of time snoring greater than 30, 40 or 50 dB was
not signicantly impacted by appliance and position. Twelve patients
snored above 50 dB for greater than 5% of the night at baseline; the
titration appliance and custom appliances reduced the snoring by at
least 50% in seven and eight cases (58% and 67%), respectively. e
titration appliance reduce the percentage of time snoring greater
than 40 dB at baseline in 44% (7 of 16) of the cases while the custom
appliance reduced snoring in 56% (9 of 17) of the cases.
Use of titration appliance to determine 70% protrusion resulted
in 79% of the patients being advanced exactly the same (11/19) or 1
mm less (4/19) than the custom appliance. One patient was advanced
2 mm less, another 2 mm more than the custom appliance but both
had similar outcomes. One patient was advanced 4 mm less than the
custom appliance but neither appliance provided therapeutic benet.
Another patient was advanced 4 mm less than the custom appliance,
and this setting may have contributed to the titration appliance being
18% less ecacious.
Estimations of neutral and the maximum voluntary protrusion
were least reliable in the rst of the three trials. Rejection of the
rst measure and averaging of the next two trials was superior to
averaging across the three trials. Variability was more apparent when
determining the neutral position with the titration appliance and the
maximum protrusion setting with the George gauge. In 74% of the
cases (14/19), the George gauge measured a greater voluntary range
than the titration appliance, possibly explained by dierences in the
VDO during measurement (i.e., George gauge = 4 mm and the titration
appliance = 8 mm). Two outliers, whereby the range of protrusion was
2 and 4 mm greater with the titration appliance vs. the George gauge,
did not appear to impact ecacy.
Seventeen of the 19 patients who wore the titration appliance
completed the survey. e six survey questions are presented in Table 1
in conjunction with the median responses to each question. Responses
to each question included: strongly agree, agree, neither agree nor
disagree, disagree, or strongly disagree. Table 2 identies features of the
titration appliance reported by patients as contributing to less comfort
or poorer quality sleep as compared to their custom appliance.
Discussion
is is the initial report pertaining to the ecacy and reliability of
the Apnea Guard, an inexpensive, easy to use titration/temporary oral
**
** p < 0.01
* p < 0.05
Figure 3: Mean + standard error for the overall, supine and non-supine apnea
index at baseline and with the titration and custom oral appliances.
Survey Question Median response
1. The comfort of my custom appliance was
similar to the titration appliance Disagree
2. My custom appliance was more comfortable
than the titration appliance Agree
3. The quality of my sleep when I wore my
custom appliance was similar to the titration
appliance
Neither agree or disagree
4. My sleep quality was better when I wore my
custom appliance compared to the titration
appliance
Agree
5. The quality of my sleep when I was NOT
wearing either appliance was similar to when I
wore my custom appliance
Disagree
6. The quality of my sleep when I was NOT
wearing either appliance was similar to when I
wore the titration appliance
Disagree
Table 1: Questions and responses to Comfort and Sleep Quality Survey.
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 4 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
*
**
** p < 0.01
* p < 0.05
**
**
Figure 4: Mean + standard error for the overall, supine and non-supine apnea/hypopnea index at baseline and with the titration and custom oral appliances.
Figure 5: Changes in the overall apnea/hypopnea index with the titration and custom appliance in patients with a) severe, and b) mild or moderate OSA.
Figure 6: Percent change from baseline in the overall apnea/hypopnea index with the titration or custom appliance in patients with a) severe, and b) mild or moderate
OSA with outlier that changed -100% and – 67% not shown (AHI - baseline = 9, titration = 18, and custom = 15).
appliance. In this study, a head to head comparison was made between
a previously fabricated custom appliance set to an optimized protrusion
and the titration appliance set to 70% protrusion. Both appliances
performed well with signicant reductions in the mean overall and
supine apnea and apnea/hypopnea indexes observed. Seventy-seven
percent of patients exhibited ecacious outcomes with the custom
appliance, based on a 50% reduction in AHI, consistent with previous
reports. In three cases, the titration appliance proved inferior to the
custom appliance. In two of the three cases, notes from the patient
indicated the titration appliance may have either been removed or did
not function properly during the night. A one-night baseline (without
a wash out period) combined with a single night with 5-hours of sleep
time per appliance may have contributed to measurement variability.
Although oral appliances are commonly prescribed to reduce
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 5 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
Figure 7: Changes in the supine apnea/hypopnea index with the titration or custom appliance in patients with a) severe, and b) mild or moderate OSA.
Figure 8: Percent change from baseline in the supine apnea/hypopnea index with the titration or custom appliance in patients with a) severe, and b) mild or moder-
ate OSA.
Figure 9: Changes in the non-supine apnea/hypopnea index with the titration or custom appliance in patients with a) severe, and b) mild or moderate OSA.
snoring, mean reductions in snoring were not observed in this data set.
It is likely that the number of patients with high baseline apnea indexes
prior to the splinting of the airway contributed to this nding, given the
conversion of apneas to hypopneas increases the percentage of sleep
time with loud snoring.
e results from this study while promising should be interpreted
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 6 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
** p < 0.01
* p < 0.05
**
*
Figure 10: Mean + standard error for the overall, supine and non-supine SpO2 desaturation across events with a 50% reduction in tidal volume.
Figure 11: Changes in the SpO2 desaturation across all events with a 50% reduction in tidal volume in patients with a) severe, and b) mild or moderate OSA.
Figure 12: Changes in the SpO2 desaturation across supine events with a 50% reduction in tidal volume in patients with a) severe, and b) mild or moderate OSA.
with caution given the small sample size and inclusion of patients
previously treated with a custom appliance. e ndings point to the
need for prospective exploration of a number of topics related to both
oral appliance therapy in general and the titration appliance specically.
Case reports suggest airway patency adapts slightly aer initiation
of oral appliance therapy at 60% protrusion. is factor contributes to
the need for subsequent advance. e assumption that 70% protrusion
for the titration appliance would be close to optimal was conrmed
by the fact that the mandibular advancement of the titration and
custom appliances were essentially the same in over 80% of the cases.
e study design did not address the concern that initiation of therapy
at 70% protrusion vs. the traditional 60% may increase the level of
initial discomfort in patients who have not previously undergone oral
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 7 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
appliance therapy. Future studies are planned to compare the impact
of initiating therapy at 60% vs.70% protrusion on the number of days
patients report morning muscular discomfort. e timing of when to
perform the ecacy outcome study also needs to be explored. Sleep
study results obtained during the rst night of therapy may be useful in
identifying patients who respond to oral appliance therapy. It is unclear
whether these initial results can also establish the appliance has been
optimally set.
e two custom appliances used in this study employ dierent
mechanics to position the mandible. One of the appliances provided
for subtle adjustment of the VDO while the other is xed. A lack of
control over the vertical dimensions of occlusion (VDO) settings of
the custom appliances did not appear to contribute to a systemic bias,
although the sample sizes were too small for statistical comparison. e
investigators believe that the 8 mm VDO of the titration appliance was
greater than the VDO settings of the custom appliances in most cases.
Although the impact of VDO on oral appliance outcomes is unclear,
preliminary evidence suggests males and females respond dierently
[17]. Increasing the VDO provides more room in the oral cavity for large
tongues to advance. It is possible that the increased VDO explains why
the titration appliance was slight less eective in reducing the number
of apneas and hypopneas (primarily in the non-supine position), while
simultaneously providing superior management of hypoxemia across
all sleep disordered breathing events with a 50% decrease in tidal
volume. Subsequent to this study titration appliances were developed
with 5.5(low) and 6.5 mm (medium) VDO to complement the 8.0 mm
(high) VDO appliance. A study is underway to compare dierences
in outcomes when patients wear the low, medium and high VDO, all
advanced to 70% protrusion.
e titration appliance could be used in additional research to
investigate how to enhance OSA therapies. For example, if the VDO
or protrusion settings that optimize oral appliance therapy outcomes
are dierent for the supine vs. non-supine position, outcomes could be
optimized by adjusting the oral appliance for the non-supine position
and using it combination with position therapy. e titration appliance
could be used to assess whether acceptance of nasal EPAP is enhanced
by mandibular advancement and/or whether an oral appliance can be
used as an alternative to a chin strip to reduce mouth breathing. e
benet of combined OAT and surgery could be inexpensively assessed
by ear, nose and throat physicians prior to referral for a custom
appliance.
e titration appliance is limited to 30-nights of use based, in
part, on the assumption that patients with no contra-indications can
safely wear it for a short duration. e 30-day window cleared by FDA
provides time for a patient to be tted and undergo a titration study
initiated by their physician and continue therapy until a dentist can
deliver a custom appliance. Alternatively, if the appliance is used to
manage OSA perioperatively, sucient time is provided for the patient
to recover from surgery, receive a consult and be diagnosed and treated.
In both of these examples, non-dental personnel are expected to t and
set the titration appliance. Studies are underway to demonstrate that
side eects are limited with use of the dental history and consent form,
patient instructions and training materials developed for tting the
appliance by sleep center or hospital personnel sta.
Patients found the custom appliance more comfortable, but
preferred the titration appliance to no therapy. To avoid a negative
bias toward OAT developing during the trial period, patients need to
be educated that custom appliances are more comfortable and that
excessive salivation during sleep will subside. Additional studies are
needed to assess compliance in patients who have not previously worn
an oral appliance, especially if the titration appliance were to be used
for management of perioperative OSA severity.
Studies are underway to demonstrate that the VDO size
and protrusion setting of the titration appliance combined with
extracted retention material used for the bite registration allows the
demonstrated optimal relationship between the upper and lower dental
arch to be articulated into the custom appliance. is approach could
reduce the eort required by dentists and patients to adjust and test the
custom appliance. It would also increase consistency of outcomes when
custom appliances are tted by less experienced dentists. Patients could
continue to using the titration appliance when retted with a second set
of retention material until the custom appliance is delivered.
Conclusions
is study suggests that a titration appliance that provides that
capability for 1 mm incremental mandibular advancement can be used
to assess oral appliance treatment ecacy. Alternatively the appliance,
when set to 70% of maximum protrusion may provide immediate,
temporary therapy for OSA. Future studies are needed to conrm these
ndings.
Acknowledgements
The subjects included in this study were originally recruited and tted with
custom appliances under NIH grant 2R44DE01772-02 Sleep Apnea Identication
and Treatment in Dentistry. The authors wish to thank Victoria Melzer and Chris
Gove for their assistance with data acquisition, and Dr. Djordje Popovic for his
assistance with data analysis.
Conicts of Interest
All three authors would benet nancially if ownership of the Apnea Guard
patent were to be acquired by a third party.
References
1. Holley AB, Lettieri CJ, Shah AA (2011) Efcacy of an adjustable oral appliance
and comparison with continuous positive airway pressure for the treatment of
obstructive sleep apnea syndrome. Chest 140: 1511-1516.
2. Levendowski DJ, Morgan TD, Patrickus JE, Westbrook PR, Berka C, et al.
(2007) In-home evaluation of efcacy and titration of a mandibular advancement
device for obstructive sleep apnea. Sleep Breath 11: 139-147.
3. Chung JW, Enciso R, Levendowski DJ, Morgan TD, Westbrook PR, et al.
(2010) Treatment outcomes of mandibular advancement devices in positional
and non-positional OSA patients. Oral Surg Oral med Oral Pathol Oral Radiol
Endod 109: 724-731.
4. de Almeida FR, Lowe AA, Tsuiki S, Otsuka R, Wong M, et al. (2005) Long-term
compliance and side effects of oral appliances used for the treatment of snoring
and obstructive sleep apnea syndrome. J Clin Sleep Med 1: 143-152.
5. Ang HC, Dreyer C (2010) A Comparison of Dental Changes Produced by
Mandibular Advancement Splits in the Management of Obstructive Sleep
Apnoea. Aust Orthod J 26: 66-72.
6. Aarab G, Lobbezoo F, Hamburger HL, Naeije M (2011) Oral appliance therapy
versus nasal continuous positive airway pressure in obstructive sleep apnea: a
randomized, placebo-controlled trial. Respiration 81: 411-419.
7. Aarab G, Lobbezoo F, Heymans, MW, Hamburger HL, Naeije M (2011) Long-
term follow-up of a randomized controlled trial of oral appliance therapy in
obstructive sleep apnea. Respiration 82: 162-168.
Table 2: Features that made titration appliance less comfortable than the custom
appliance.
Complaint n (%) Complaint n (%)
Increased nocturnal
drooling 5 (26) Did not retain as well to teeth 3 (16)
Rubbed against
gums or tongue 5 (26) Bulky 2 (11)
Could not maintain a
lip seal 3 (16) Restricted jaw movement 2 (11)
Citation: Levendowski DJ, Morgan T, Westbrook P (2011) Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep
Apnea. J Sleep Disord Ther 1:101. doi:10.4172/jsdt.1000101
Page 8 of 8
Volume 1 • Issue 1 • 1000101
J Sleep Disord Ther
ISSN: JSDT, an open access journal
8. Lettieri CJ, Paolino N, Eliasson AH, Shah AA, Holley AB (2011) Comparison
of adjustable and xed oral appliances for the treatment of obstructive sleep
apnea. J Clin Sleep Med 7: 439-445.
9. Almeida FR, Parker JA, Hodges JS, Lowe AA, Ferguson KA (2009) Effect of a
titration polysomnogram on treatment success with a mandibular repositioning
appliance. J Clin Sleep Med 5: 198-204.
10. Ahrens A, McGrath C, Hagg U (2011) A systematic review of the efcacy of
oral appliance design in the management of obstructive sleep apnoea. Eur J
Orthod 33: 318-324.
11. Ahrens A, McGrath C, Hagg U (2010) Subjective efcacy of oral appliance
design features in the management of obstructive sleep apnea: a systematic
review. Am J Orthod Dentofacial Orthop 138: 559-576.
12. Ayappa I, Norman RG, Seelall V, Rapoport DM (2008) Validation of a self-
applied unattended monitor for sleep disordered breathing. J Clin Sleep Med
4: 26-37.
13. Levendowski D, Steward D, Woodson BT, Olmstead R, Popovic D, et al. (2009)
The impact of obstructive sleep apnea variability measured in-lab versus in-
home on sample size calculations. Intl Arch Med 2: 2.
14. Masdeu MJ, Ayappa I, Hwang D, Mooney AM, Rapoport DM (2010) Impact
of clinical assessment on use of data from unattended limited monitoring as
opposed to full-in lab PSG in sleep disordered breathing. J Clin Sleep Med 6:
51-58.
15. Westbrook PR, Levendowski DJ, Cvetinovic M, Zavora T, Velimirovic V, et al.
(2005) Description and validation of the Apnea Risk Evaluation System: a novel
method to diagnose sleep apnea-hypopnea in the home. Chest 128: 2166-
2175.
16. To KW, Chan WC, Chan TO, Tung A, Ngai J, et al. (2009) Validation study
of a portable monitoring device for identifying OSA in a symptomatic patient
population. Respirology 14: 270-275.
17. Levendowski D, Popovic D, Morgan T, Melzer V, Westbrook P (2009) Assess-
ing changes in the AHI resulting from increased vertical dimension of occlusion
(VDO) of mandibular repositioning devices. Sleep Breath13: 308.
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Long-term trials are needed to capture information regarding the persistence of efficacy and loss to follow-up of both mandibular advancement device (MAD) therapy and continuous positive airway pressure (CPAP) therapy. The aim of the study was to compare these treatment aspects between MAD and nasal CPAP (nCPAP) in a 1-year follow-up. Forty-three mild/moderate obstructive sleep apnea patients (52.2 ± 9.6 years) with a mean apnea-hypopnea index (AHI) of 20.8 ± 9.9 events/h were randomly assigned to two parallel groups: MAD (n = 21) and nCPAP (n = 22). Four polysomnographic recordings were obtained: one before treatment, one for the short-term evaluation, and two recordings 6 and 12 months after the short-term evaluation. Excessive daytime sleepiness (EDS) was also evaluated at the polysomnographic recordings. The initially achieved improvements in the AHI remained stable over time within both groups (p = 0.650). In the nCPAP group, the AHI improved 4.1 events/h more than in the MAD group (p = 0.000). The EDS values showed a gradual improvement over time (p = 0.000), and these improvements were similar for both groups (p = 0.367). In the nCPAP group, more patients withdrew from treatment due to side effects than in the MAD group. The absence of significant long-term differences in EDS improvements between the MAD and the nCPAP groups with mild/moderate obstructive sleep apnea may indicate that the larger improvements in AHI values in the nCPAP group are not clinically relevant. Moreover, nCPAP patients may show more problems in accepting their treatment modality than MAD patients.
Article
The purpose of this study was to review available evidence on the efficacy of various oral appliances on subjectively perceived symptoms of obstructive sleep apnea syndrome. A search of 4 databases was carried out. Articles were initially selected based on their titles or abstracts. Full articles were then retrieved and further scrutinized according to predetermined criteria. Reference lists of selected articles were searched for any missed publications. The finally selected articles were methodologically evaluated. Of an initial 1475 references, 14 studies were randomized controlled trials, which formed the basis of this review. Mandibular advancement devices (MADs) were compared with either inactive appliances (6 studies) or MADs with different design features (8 studies). In comparison with inactive appliances, the majority of studies showed improved subjective outcomes with MADs, suggesting that mandibular advancement is a crucial design feature of oral appliance therapy for obstructive sleep apnea syndrome. There is no 1 MAD design that most effectively influences subjectively perceived treatment efficacy, but efficacy depends on many factors including materials and method used for fabrication, type of MAD (monoblock or Twin-block), and the degree of protrusion (sagittal and vertical). This review highlights the absence of universally agreed subjective assessment tools and health-related quality of life outcomes in the literature today. Future trials of MAD designs need to assess subjective efficacy with agreed standardized tools and health-related quality of life measures to guide clinical practicitioners about which design might be most effective in the treatment of obstructive sleep apnea syndrome with oral appliances.
Article
Previous randomized controlled trials have addressed the efficacy of mandibular advancement devices (MADs) in the treatment of obstructive sleep apnea (OSA). Their common control condition, nasal continuous positive airway pressure (nCPAP), was frequently found to be superior to MAD therapy. However, in most of these studies, only nCPAP was titrated objectively but not MAD. To enable an unbiased comparison between both treatment modalities, the MAD should be titrated objectively as well. The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device. Sixty-four mild/moderate patients with obstructive sleep apnea (OSA; 52.0 ± 9.6 years) were randomly assigned to three parallel groups: MAD, nCPAP and placebo device. From all patients, two polysomnographic recordings were obtained at the hospital: one before treatment and one after approximately 6 months of treatment. The change in the apnea-hypopnea index (ΔAHI) between baseline and therapy evaluation differed significantly between the three therapy groups (ANCOVA; p = 0.000). No differences in the ΔAHI were found between the MAD and nCPAP therapy (p = 0.092), whereas the changes in AHI in these groups were significantly larger than those in the placebo group (p = 0.000 and 0.002, respectively). There is no clinically relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objectively.