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182
S. Paruthi
tilled water is used nightly and the excess dumped out each morning, with the humidier container allowed to air dry between uses. The benets of distilled water include that it is mineral- free and microorganism-free due to the process of distilling water. Water is boiled, and only the evaporation is collected to create distilled water. Due to presence of microorganisms, it is not advised to use tap water or well water on a daily basis, as the air in the PAP machines pick up moisture from the humidier chamber.
12.6.6 Ramp
The ramp feature is a patient-comfort feature. When the machine is started, or anytime during the night, with the push of a button, the air pressure can be “reset” and restarted at a previously lower set pressure. For example, for a person on an APAP machine with a range of 8–10cmH20 and a ramp start pressure of 4cmH20, each time the person desires, s/he can push the ramp button and restart the pressure at 4cmH20. This setting allows the pressure to slowly increase to the goal pressure set­ting, over a prespecied time period. Ramp time periods can be set from 5 to 45minutes on most machines.
12.6.9 Nasal Congestion
Some patients will experience nasal congestion, while others will experience clearing of their nasal conges­tion after starting PAP therapy. Over-the-counter saline- based solutions are available to help with nasal congestion or dryness, and can be applied inside the nostril prior to using PAP. An alternative is petro­leum jelly.
Additionally for persons with signicant “runny” nose, prescription ipratropium bromide spray can be sprayed inside the nostrils. For people with “stuffy” nose, a nasal corticosteroid can be considered. Nasal saline rinse or squeeze bottles may be helpful. Treatment for seasonal allergies is also recommended with antihis­tamines or leukotriene inhibitors.
12.6.10 Aerophagia
Some patients will describe increased belching, burp­ing, or passing gas after waking up after starting PAP therapy due to swallowing air. Treatment of this aero­phagia is to decrease the machine pressure setting or pressure range until this no longer occurs, yet main­tains a low RDI.
12
12.6.7 Cleaning Equipment
12.6.8 Skin Irritation
Skin care is an important consideration for PAP users. The mask t should be snug, not too tight, and not too loose. Masks should t comfortably, without leav­ing lasting red marks or indentations after 7hours of continuous use. It is normal to have some indenta­tions for a few minutes after removing the mask. For patients who get red sores or skin irritation, petro­leum jelly or zinc oxide preparations can help soothe and heal the skin.
Sometimes the mask needs to be exchanged for a dif­ferent style altogether. Sometimes people alternate dif­ferent mask styles so that the face does not have constant pressure in the same place every night. Wraps are small cloths with Velcro designed to wrap around the PAP straps to cushion the skin to decrease the appearance of indentations. For patient who use the nasal pillow-style masks and have chang to the skin between their nos­trils, they may need to consider switching masks.

12.7 Cleaning Equipment

Cleaning the equipment is vital to equipment longevity.
The mask cushion, which can be dissembled from the headgear, should be washed with a gentle dish soap, wiped, or sanitized daily. Baby wipes or CPAP­designated wipes can ease the burden of daily cleaning to remove the natural oils, sweat, and nasal drainage that can accumulate on the mask cushion. Alcohol­containing or bleach-containing wipes should not be used. The headgear and other plastic parts of the mask should be hand-washed at least weekly. The tubing and humidier chamber should be cleaned weekly with soap and water. After a night of use, any water remaining in the humidier container should be emptied daily in the morning and the water container allowed to air-dry. Filters should be changed as specied in the user man­ual.
Additionally, for intermittent, more thorough antimicrobial cleaning, the equipment may be soaked in a vinegar mixture, typically 1 part vinegar to 5 parts water for about 15minutes. This can be consid-
Positive Airway Pressure fortheTreatment ofObstructive Sleep Apnea
183
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ered every few months or particularly after a person has used their PAP equipment while also suffering from an upper respiratory infection. Several chemical sanitizers or ultraviolet light sanitizer devices are available on the market for purchase to clean the machines; however, there are no data to suggest that these are more benecial over traditional soap and water cleaning.
12.7.1 Travel Options
Travel CPAP and APAP machines are available from durable medical equipment suppliers. The machines can be used plugged in at night or used with an addi­tional battery attachment. Optional humidiers or humidifying mechanisms may be available. However, not every mask ts with every travel machine. The tub­ing is typically less wide and less heavy, so it pulls on the mask less. Heated tubing is currently not available. Currently, some travel machines can provide adherence reports.

References

1. Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod
CG.Treatment of adult obstructive sleep apnea with positive
airway pressure: an American Academy of clinical practice
guideline. J Clin Sleep Med. 2019;15(2):335–43.
2. Sullivan C, Issa F, Berthon-Jones M, etal. Reversal of obstruc-
tive sleep apnea by continuous positive airway pressure applied
through the nares. Lancet. 1981;1:862–5.
3. McArdle N, Devereux G, Heidarnejad H, etal. Long-term use
of CPAP therapy for sleep apnea/hypopnea syndrome. Am J
Respir Crit Care Med. 1999;159(4):1108–14.
4. Kribbs NB, Pack AI, Kline LR, etal. Objective measurement of
patterns of nasal CPAP use by patients with obstructive sleep
apnea. Am Rev Respir Dis. 1993;147(4):887–95.
5. Kushida A, Chediak RB, etal. Clinical guidelines for the manual
titration of positive airway pressure in patients with obstructive
sleep apnea. J Clin Sleep Med. 2008;4(2):157–71.
6. Rosen CL, Auckley D, Benca R, etal. A multisite randomized
trial of portable sleep studies and positive airway pressure
autotitration versus laboratory-based polysomnography for the
diagnosis and treatment of obstructive sleep apnea: the
HomePAP study. Sleep. 2012;35(6):757–6.
7. Schwartz Y, Wasserlauf J, Sahakian AV, Knight B.Inappropriate
activation of pacemaker magnet response by CPAP masks.
Pacing Clin Electrophysiol. 2019;42(8):1158–61.

Oral Appliance Therapy

Marie Marklund
Contents
13.1 Introduction – 187
13.2 Terminology – 188
13.3 Devices That Hold theMandible Anteriorly—OAM – 188
13.3.1 Mechanism ofAction – 188
13.3.2 Device Designs – 188
13.4 Methodology – 190
13.5 Short-Term Eects onAHI – 190
185
13
13.6 Denitions ofTreatment Success – 190
13.7 Factors Related totheEcacy ofOAM – 191
13.7.1 Importance ofMandibular Repositioning – 191
13.7.2 Device Design – 191
13.7.3 Determining theOptimal Mandibular Position andFind Responders toOAM Therapy – 192
13.7.4 Pharyngeal Anatomy andPhysiology – 193
13.7.5 Non-anatomical Traits – 193
13.7.6 Disease Severity – 193
13.7.7 Supine Dependency – 193
13.7.8 Anthropometric Variables fromtheClinical Examinations – 194
13.8 Eects ofOAs onSnoring andthe Upper Airway Resistance Syndrome – 194
13.9 Symptomatic Eects ofOAs – 195
13.10 Cardiovascular Eects – 196
13.11 Side Eects – 196
13.11.1 Forces fromtheDevice – 196
13.11.2 Short-Term Side Eects – 196
13.11.3 Methods toAvoid Initial Side Eects – 197
13.11.4 Longer Term Side Eects – 197
13.11.5 Changes inDental Occlusion – 197
© Springer Nature Switzerland AG 2021 K. B. Kim et al. (eds.), Management of Obstructive Sleep Apnea, https://doi.org/10.1007/978-3-030-54146-0_13
13.11.6 Bite Changes inRelation toInitial Bite Characteristics – 199
13.11.7 Bite Changes inRelation toMandibular Repositioning – 199
13.11.8 Device Design andPossibilities toPrevent Bite Changes – 199
13.11.9 Comparison ofBite Changes Between PAP andOAM – 199
13.12 Adherence andMean Disease Alleviation – 200
13.12.1 Measurement ofAdherence – 200
13.12.2 Denitions ofAdherence – 200
13.12.3 Adherence – 200
13.12.4 Mean Disease Alleviation – 200
13.12.5 Reasons forOA Non-adherence withOAM – 200
13.13 Long-Term Outcomes – 201
13.14 OAM in Relation to Other OSA Treatments – 202
13.14.1 OAM Compared with Positional Therapy – 202
13.14.2 OAM Combined with Positional Therapy – 202
13.14.3 OAM Combined with PAP – 202
13.15 OAs asSecond-Line Treatment – 202
13.16 Guidelines – 202
13.17 Summary ofOAM – 203
13.18 Devices That Hold theTongue Forward—OAT – 203
13.18.1 Eects – 203
13.18.2 Side Eects – 203
13.18.3 Summary ofOAT – 203
References – 204
Oral Appliance Therapy
187
13

13.1 Introduction

Oral appliances (OAs) aim to increase the upper air­way size, facilitate breathing during the night, and reduce obstructive sleep apnea (OSA) and snoring (. Fig.13.1a, b). There are two subgroups of OAs: the mandibular advancement device (OAM) (. Fig. 13.2) and the tongue- retaining device (OAT) (. Fig. 13.3). OAM is attached to the teeth and holds the mandible forward during sleep. This treatment has the highest level of evidence among non-PAP therapies [14]. OAT aims to hold the tongue forward into an anterior bulb by suction and can be used irrespective of the presence
a
of teeth. Both devices reduce sleep apneas, but OA
is
M
better tolerated and has been much more studied.
This chapter primarily describes OAM treatment; the effects, the side effects, and the longer term out­comes. The efcacy of OA is more variable than that of PAP, since its mechanism of action depends on a number of factors such as the degree of mandibular or tongue advancement and OSA endotype [5]. OAM can be used solely or in combination with other sleep apnea treatments such as positive airway pressure (PAP) or positional therapy, when the efcacy of OA alone is insufcient. The adverse effects of OAs are generally mild, but in the longer term, there are risks of tooth
b
. Fig. 13.1 a Illustration of the mechanism of the oral appliance. b Photo without (left) and with (right) the oral appliance showing the
widening of the upper airway with the appliance in place compared to without it
13
188
M. Marklund
. Fig. 13.2 Schematic illustration of the OA
. Fig. 13.3 Schematic illustration of the OA
M
T
movements from the forces of these devices. OA treat­ment must be continuously followed-up regarding ef­cacy, side effects, and adherence.
13.3 Devices That Hold theMandible
Anteriorly—OA
13.3.1 Mechanism ofAction
M
OAM repositions the lower jaw anteriorly and slightly opened in order to increase the upper airway volume and reduce the pharyngeal collapsibility (. Fig.13.1a) [710]. The upper airway is enlarged, particularly in its lateral dimension at the velopharyngeal level (. Fig. 13.1b), and the tongue is displaced anteriorly [8, 9, 11, 12]. The mechanism of action of OAM is vari­ably efcient depending on a number of factors such as OSA pathogenesis and OA design. To various degrees, OSA patients may have some degree of anatomical com­promise in their upper airway, a reduced dilator mus­cular activity, an increased pharyngeal collapsibility, an overly sensitive ventilatory control system (high loop gain), or a low arousal threshold [13]. OA
compensates
M
for individual deciencies in upper airway anatomy. Non- anatomical traits such as a high loop gain or a low arousal threshold are unchanged by OAM [14]. Patients with mild OSA are generally better suited for the mecha­nism of OAM compared with patients with more severe OSA, since mild OSA patients often have less collapsible airways [13, 14]. Pharynx has also been found to widen more, along its whole length in mild OSA patients, com­pared with patients with more severe disease [15].
In summary, the mechanism of action of OAM is less effective compared with PAP that increases the airow in the upper airway in relation to the needs of each patient. This means that the indications of OAM are more dif­cult to assess and that the treatment has to be more rig­orously controlled and followed up compared with PAP.

13.2 Terminology

OA is a generic term for devices that are inserted into the mouth in order to modify the position of the tongue and other structures to reduce snoring and sleep apnea [6]. The oral appliance that holds the mandible ante­riorly, the OA
is also termed “mandibular advance-
M
ment device (MAD),” “mandibular advancement splint (MAS),” “mandibular repositioning appliance (MRA),” “unterkieferprotusionsschiene (UPS),” and “orthèses d’avancée mandibulaire (OAM).” A device that holds the tongue forward, OAT, is named “tongue-retaining device (TRD)” or “tongue-stabilizing device (TSD).” There are combinations of OAM and OAT including both mechanisms. Most commonly, the term OA is used syn­onymously for OAM, since this type of OA has become overwhelmingly most common.
13.3.2 Device Designs
There are many various designs of OAM (. Fig.13.4a– h), and they may be subdivided in various ways. There are custom-made devices and prefabricated ones. The evidence for the efcacy of OA
therapy is primar-
M
ily based on the results of custom-made devices. The knowledge about custom-made devices will therefore constitute the major part of this chapter.
OAMs have various types of adjustment mecha­nisms between the jaws in order to facilitate changes in jaw positioning and improve the efcacy and tolerabil­ity of the device [1619]. The adjustment mechanism can be located either laterally on each side of the jaws (. Fig. 13.4a–d) or in the midline (. Fig. 13.4e–f). These mechanisms are primarily intended for anterior­posterior adjustments of the lower jaw during the titration procedure when the optimal jaw position is
a
b
c
e
gh
Oral Appliance Therapy
189
d
13
f
. Fig. 13.4 ag Various designs of adjustable OAM. The adjust-
ment mechanism of the device may be located laterally a–d or in the midline e–f. Some appliances allow mouth opening a–e. Elastic
determined. During use, the jaws can be xed rmly together by the mechanism (. Fig.13.4f). More or less mouth opening can also be allowed with other types of mechanisms (. Fig.13.4a–e). This mouth opening can be prevented by the use of elastic bands (. Fig.13.4g).
bands can be applied in different ways in order to hold the jaws together and certify the degree of advancement g. A new device introduces a combination of lateral and midline mechanism h
Lateral adjustment or some movement in the lateral dimension is possible in several designs. The earliest types of OAM were made in one piece and lacked this adjustment mechanism. Titration of mandibular posi­tioning was more difcult, since it required new con-
190
M. Marklund
13
struction bites and help from a dental technician to remake the device with the lower jaw in a new position.
An opening within the appliance to allow mouth breathing might be important for many patients, since nocturnal nasal obstruction is reported by one third of sleep apnea patients [20]. Still, it is essential that the appliance allows the lips to close in order to primarily promote nasal breathing.
In summary, custom-made oral appliances that allow titration of the lower jaw position are recom­mended. These appliances are most commonly used in clinical practice, since the adjustment mechanism is con­sidered to be important for the efcacy and tolerance of the device.

13.4 Methodology

Good oral health is essential for treatment success with OAM and it is therefore important with a complete odont­ological investigation including dental occlusion, jaw movements, and the temporomandibular joint. Patients with poor oral health should be treated for these condi­tions before OAM therapy is initiated. Existing odonto­logical diseases will increase the risk of further impaired oral health, side effects, and a poor treatment outcome. If the teeth are unsuited to hold the lower jaw forward, the mechanism of the device is also jeopardized.
OAM therapy starts with impressions or intraoral scanning of the teeth. Thereafter, a bite registration in an advanced mandibular position is taken in wax or other material. This registration is advised to be taken with the mandible advanced straight forward and approximately 50% forward of maximum protru­sive capacity or 4–6mm compared with centric rela­tion. In patients with a poor protrusive capacity, some increase in protrusive capacity might be expected dur­ing the rst months’ of treatment [21]. A bite fork or a steel sliding caliper can be used to help the patient nd this position. After fabrication and adaptation of the device to the teeth of the individual patient, a test period starts with acclimatization and titration of the lower jaw forward. This means that the lower jaw is continuously advanced in steps of in between
0.1 and 1mm until an effective mandibular position­ing is identied. A renewed sleep apnea recording has to be performed in order to verify the treatment out­come of OA
on breathing stops and oxygenation.
M
Such recordings must be repeated until an effective mandibular position is found, particularly in patients with moderate to severe disease or comorbidities. Intermediate testing during the titration procedure can be performed at the dentist’s ofce, depending on the health-care system in each country. The nal decision about the efcacy of the device in relation to
the individual patient’s health is made by the referring sleep physician. In the future, this titration procedure may be simplied by an overnight testing of the opti­mal mandibular positioning at home [22] or by the use of auto adapting devices [23].
In summary, OAM therapy requires good oral health, a time for adaptation and titration of an optimal jaw positioning, and conrmation of the efcacy of the treatment in renewed sleep apnea recordings.
13.5 Short-Term Eects onAHI
OAM reduces AHI effectively compared with placebo interventions or untreated controls [2437] (. Fig.13.5). PAP is more effective than OAM in reducing AHI, accord­ing to studies comprising patients with varying disease severity [24, 25, 32, 3845] (. Fig. 13.6). Among the mildest OSA patients, this difference becomes smaller or is levelled out [3, 24, 42, 46]. The nightly oxygenation is improved with OA
[2, 3], but PAP restores the nightly
M
oxygenation even further [2].
13.6 Denitions ofTreatment Success
There are several denitions of treatment success for OAM therapy [47]. These are based either on strict cut­off points, such as an AHI of below 5 or 10 or a per­centage cut-off, usually a 50% or more reduction in AHI.Combinations of criteria are also used, such as an AHI <5 + the resolution of symptoms or AHI <5 or 10+50% or more reduction in AHI.The last criterion assures a sufcient AHI reduction also among the mild­est cases.
Complete responders are dened by an AHI <5, often with an additional requirement of 50% reduction or more in AHI, non-responders have less than 50% reduction in AHI and a treated AHI of above a specic level, such as 20, and partial responders lie in between [28, 29, 4143].
The proportion of patients who receive complete suc­cess with an AHI<5 sometimes with an additional require­ment of 50% reduction in AHI varies in between 10% and 57% in randomized controlled trials including patients of varying disease severity [2629, 3436, 38, 4143]. The reason for this large variability in response to OA
therapy
M
depends on factors such as disease severity, patients’ phe­notype, denitions of sleep-disordered breathing events, and methodology including device design.
In summary, there is a high level of evidence of a satisfactory AHI reduction by OA
. The variability
M
in treatment response means that PAP will represent a more efcient alternative, particularly among the more severe OSA patients.
50
AHI or RDI
Hans et al. 1997 Petri et al. 2008 Gagnadoux et al. 2017
Oral Appliance Therapy
45
40
35
30
25
20
15
10
191
13
5
0
Baseline Placebo Baseline OA
Durán-Cantolla et al. 2015 Marklund et al. 2015 Barnes et al. 2004 Mehta et al. 2001
Gotsopoulos et al. 2002 Naismith et al. 2005 Johnston et al. 2002 Blanco et al. 2005
. Fig. 13.5 Effect of OAM compared with baseline and placebo
13.7 Factors Related totheEcacy ofOA
13.7.1 Importance ofMandibular
Repositioning
A larger advancement of the mandible will generally produce a higher efcacy of OAM [7, 48], but there is no exact linear relationship between mandibular advance­ment and treatment success [49, 50]. In addition, the needed advancement might be inuenced by disease severity or other individual factors [51]. Despite this, an insufcient capacity of the patient to move the man­dible forward to some degree will limit the possibilities to receive an optimal treatment outcome with OAM therapy. A device that is produced with the mandible extensively opened is likely to produce a poorer result [52] compared with a device that is constructed within a more limited range of mandibular opening [53, 54]. Too wide openings over a centimeter have also been related to discomfort for the patient [54].
13.7.2 Device Design
M
Comparison between different devices regarding their efcacy in reducing AHI have been made in 13 ran­domized controlled trials [37, 5465] and four non­randomized studies [6669]. Nine of the 13 randomized studies compared various custom-made designs [5458,
6062, 64, 65] and showed no or only small differences.
Two studies compared a custom-made device versus a prefabricated one [59, 63] and both favored the custom­made designs. Complete treatment response was found in 49% [63] and 64% [59] of the patients when they used a custom-made design and in only 17% and 24%, respectively, when they were treated with a prefabricated device. This result is further supported by results of a non-randomized study [66]. The prefabricated device was also unreliable as test device to nd responders to OAM according to one study [63]. In addition, the results from a large study including various degrees of customized devices showed fairly small AHI reductions
192
50
eC
AHI
Gagnadoux et al. 2009 Hoekema et al. 2008
M. Marklund
45
40
35
30
25
20
15
10
13
5
0
Baseline OA Baselin
Randerath et al. 2002 Ferguson et al. 1996 Lam et al. 2007 Barnes et al. 2004
Tan et al. 2002 Ferguson et al. 1997 Phillips et al. 2013 Engleman et al. 2002
. Fig. 13.6 Effect of OAM compared with baseline and PAP
by non- customized designs, although they did not dif­fer signicantly [37]. The retention of non-customized designs might be one explanation to their poor efcacy [70], although the properties of the materials in these devices are improving [69, 71].
Adjustable devices where one of them xate the lower jaw to the upper jaw and the other one allowed mouth opening were compared in seven randomized studies [5558, 62, 64, 65]. Six of them favored the xed design, four signicantly [55, 58, 62, 64]. Further support for these ndings is presented in one non- randomized study [67] and two studies comparing the inuence of elastic bands that hold the jaws together in devices that allows mouth opening [61, 68]. Based on these studies as well as some observational ones [18, 19, 67, 72], adjustable, custom-made devices that xate the lower jaw to the upper are most effective.
PAP
13.7.3 Determining theOptimal
Mandibular Position andFind Responders toOA
New technology can be used to nd the optimal mandib­ular position and predict which patients that are likely to respond to the treatment. A feedback- controlled man­dibular positioner has been developed and tested during un-attended in-home conditions [22]. This method is a further step forward and a cheaper alternative compared with the previous system using a remotely controlled mandibuilar advancement device during an attended in-hospital testing night [7375]. The developed testing method produced a high potential of predicting treat­ment success dened as an oxygen desaturation index (ODI) of less than 10 with a sensitivity 85% and a speci-
Therapy
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