Journal of

Clinical Medicine

Article
Modifications in Upper Airway Collapsibility during Sleep
Endoscopy with a Mandibular Positioner: Study in Snorers and
Obstructive Sleep Apnea Patients
Patricia Fernández-Sanjuán 1,2 , Marta Alcaraz 3 , Gabriela Bosco 1,4,5 , Nuria Pérez-Martín 1,4,5 , Marta Morato 6 ,
Rodolfo Lugo 7 , Juan José Arrieta 8 , Jaime Sanabria 9 , Marcos Ríos-Lago 10 and Guillermo Plaza 1,2,4,5, *

1 Sleep Respiratory Disorders Unit, Hospital Universitario La Zarzuela, 28023 Madrid, Spain;
patriciafsanjuan@yahoo.es (P.F.-S.); maria.bosco@salud.madrid.org (G.B.);
n.perezmartin@hotmail.com (N.P.-M.)
2 Universidad Rey Juan Carlos, 28002 Madrid, Spain
3 Department of Otolaryngology, Hospital Universitario La Moraleja, 28050 Madrid, Spain;
malfue@hotmail.com
4 Department of Otolaryngology, Hospital Universitario de Fuenlabrada, 28942 Madrid, Spain
5 Department of Otolaryngology, Hospital Universitario La Zarzuela, 28023 Madrid, Spain
6 Department of Otolaryngology, Hospital Quirónsalud San José, 28002 Madrid, Spain; marta37003@gmail.com
7 Department of Otolaryngology Head and Neck Surgery, Hospital San José, Monterrey 64718, Mexico;
rodo_lugo@me.com
8 Department of Stomatology, Hospital Universitario Fundación Jiménez Díaz, 28040 Madrid, Spain;
jjarrietab@yahoo.es
9 Department of Otolaryngology Head and Neck Surgery, Hospital Universitario Fundación Jiménez Díaz,
28040 Madrid, Spain; jsanabria@fjd.es
10 Department of Basic Psychology II, Faculty of Psychology, UNED—Universidad Nacional de Educación a
Distancia, 28040 Madrid, Spain; mrios@psi.uned.es
* Correspondence: guillermo.plaza@salud.madrid.org

Citation: Fernández-Sanjuán, P.; Abstract: Background: Mandibular advancement devices (MADs) are an effective treatment for
Alcaraz, M.; Bosco, G.; Pérez-Martín, patients with sleep-related breathing disorders, with variable response. Increasingly more research
N.; Morato, M.; Lugo, R.; Arrieta, J.J.; points to the predictive value of Drug-Induced Sleep Endoscopy (DISE) in patient selection. This
Sanabria, J.; Ríos-Lago, M.; Plaza, G. study aims to analyze the changes in upper airway collapsibility using a titratable MAD simulator
Modifications in Upper Airway
during DISE. Methods: This study included 104 patients with simple snoring and obstructive sleep
Collapsibility during Sleep Endoscopy
apnea (OSA). The VOTE scale was used to assess the presence of collapses during the DISE both
with a Mandibular Positioner: Study
without and with the MAD simulator. Results: In snorers, there was a decrease in collapses at the
in Snorers and Obstructive Sleep
level of the soft palate and oropharynx when the advancement was achieved. Patients with mild
Apnea Patients. J. Clin. Med. 2024, 13,
1184. https://doi.org/10.3390/
OSA also showed a decrease in collapses at the base of the tongue. Patients with moderate/severe
jcm13051184 OSA exhibited significant amelioration at all levels. The levels at which there were residual collapses
despite the maneuver were, in order, the velopharynx, oropharynx, epiglottis, and tongue. Conclu-
Academic Editor: Silvano Dragonieri
sions: The MAD simulator reduces collapsibility at all levels and in all severity groups. Residual
Received: 20 January 2024 collapses suitable for combined treatments were able to be identified. This highlights the need for
Revised: 6 February 2024 individualized patient selection, as upper airway collapsibility exhibits variable improvement or
Accepted: 13 February 2024 worsening with the MAD simulator regardless of the severity of the condition.
Published: 20 February 2024

Keywords: obstructive sleep apnea (OSA); collapsibility; mandibular advancement device (MAD);
titratable positioner; Drug-Induced Sleep Endoscopy (DISE)

Copyright: © 2024 by the authors.

Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
1. Introduction
conditions of the Creative Commons Sleep-related breathing disorders, snoring, and sleep apnea represent a growing
Attribution (CC BY) license (https:// concern in public health due to their prevalence and significant impact on individual
creativecommons.org/licenses/by/ quality of life. Snoring prevalence varies according to various studies, reaching 86%
4.0/). depending on the method of measurement used and the population analyzed, showing

J. Clin. Med. 2024, 13, 1184. https://doi.org/10.3390/jcm13051184 https://www.mdpi.com/journal/jcm

J. Clin. Med. 2024, 13, 1184 2 of 14

a higher prevalence in the male compared to the female gender [1,2]. It is commonly
characterized as a harsh and vibratory sound during sleep, caused by partial obstruction
principally during inspiration. Despite snoring often being trivialized, it may be the initial
sign of a spectrum of sleep-disordered breathing, which spans from partial airway collapse
and mild upper airway resistance to total airway collapse and severe obstructive sleep
apnea (OSA). There is increasing evidence that snoring is linked to several health issues.
In fact, it has been independently associated with increased odds of metabolic syndrome,
especially in women [3]. In addition, snoring is associated with a modest but significantly
increased risk of cardiovascular disease (independent of age), smoking, Body Mass Index
(BMI), and other cardiovascular risk factors [4].
Similarly, substantial methodological heterogeneity exists in studies that investigate
the population prevalence of OSA, and there is a resultant wide variation in the reported
prevalence. The Senaratna et al. [5] study concluded that the overall prevalence of any form
of OSA ranged from 9% to 38% in the general adult population, from 13% to 33% in men,
and from 6% to 19% in women. On average, the gender ratio for middle-aged individuals
is 2-3/1 for men and women, respectively. Furthermore, this prevalence increases with
age, tripling in the elderly population compared to middle-aged individuals [2,6], and
increases with obesity which is considered a major risk factor for the development and
progression of OSA [7]. Patients with OSA experience apneas and/or hypopneas during
sleep, leading to intermittent hypoxemia and changes in intrathoracic pressure that can
trigger cardiovascular and metabolic consequences. Additionally, the disruption of sleep
architecture can result in neuropsychological and psychiatric issues. All these factors lead to
a decreased quality of life, which is associated with excess mortality, making it a significant
public health concern [8].
Currently, the treatment of OSA is multidisciplinary, including common lifestyle
measures such as sleep hygiene, exercise, and weight loss [8]. Although continuous
positive airway pressure (CPAP) therapy is the most common treatment, patients may
benefit from other therapies, such as various surgical treatments, myofunctional therapy,
positional therapy, and/or the use of mandibular advancement devices (MADs) [8,9].
The first publications on the use of MADs in OSA appeared around 1980 [10,11]. There
is now evidence that MADs are an effective treatment for many OSA patients [11–14]
and are becoming an increasingly popular alternative, primarily directed at patients with
snoring, mild to moderate OSA, and those with severe OSA who reject or cannot tolerate
CPAP [13,15]. MADs aim to stabilize and advance the mandible and hyoid bone to a
forward position, preventing posterior jaw rotation when sleeping in the supine position
and upper airway (UA) obstruction. Thus, this jaw advancement aims to increase the
upper airway space predominantly at the velopharynx level, increase tension in the lateral
pharyngeal walls, and reduce their collapsibility. It also advances the tongue, separating it
from the posterior pharyngeal wall, and contributes to the tensioning of its musculature,
reducing tissue vibration and consequently decreasing snoring [13,15]. MADs can be used
in isolation, in combination, or alternated with other treatment modalities that, when used
alone, do not achieve the desired therapeutic goal [16,17], or to reduce the pressure exerted
during CPAP therapy, improving its adherence [18,19].
Various predictors of success for selecting patients who could benefit from MAD
treatment have been described in the literature. Among anthropometric parameters, note-
worthy factors include being young, female, having a low BMI, or having a smaller neck
circumference. Among polysomnographic parameters, potential responders are those
with a lower Apnea–Hypopnea Index (AHI), supine-dependent OSA, or a high minimum
oxygen saturation [20]. On the other hand, predictors of failure include the need for high
positive airway pressure [21], a narrower airway, or a long soft palate [22]. With the same
objective of analyzing modifications in the UA, studies have been published that analyze
changes using three-dimensional volumetric studies with imaging tests such as computed
tomography (CT) or cone beam computed tomography (CBCT) in awake patients using
a MAD in situ with controversial results. Some of these studies [23–26] concluded that
J. Clin. Med. 2024, 13, 1184 3 of 14

there is an increase in UA volume when the patient uses a MAD in situ, which correlates
with the improvement in the AHI in PSG. Conversely, Shi et al. [27] observed that these in-
creases in UA dimensions in CBCT with MAD use were not significantly different between
responders and non-responders. All these studies have the limitation of being conducted
in awake patients using a MAD in situ to observe changes in the UA in imaging tests.
On the other hand, it has been shown that natural sleep does not significantly differ
from drug-induced sleep regarding respiratory parameters [28] and upper airway obstruc-
tion sites [29]. Therefore, conducting a Drug-Induced Sleep Endoscopy (DISE) to evaluate
the upper airway in OSA patients appears appropriate, as it provides the most information
about airway collapsibility [30]. The study of the behavior of the airway under sedation
allows for the development of more precise and personalized approaches for the diagnosis
and treatment of respiratory disorders. It helps anticipate the likelihood of a positive or
negative response to certain treatments, enabling more informed management. DISE shows
a relevant influence on the location of the recommended treatment. Thus, a change in
success rates of non-CPAP therapy in OSA and snoring individuals appears possible [31].
Concerning MADs, different mandibular advancement maneuvers have been described
during a DISE to attempt to identify patients who respond to this therapy [32]. The objec-
tive of these maneuvers is to assess whether simulating MAD treatment during sedation is
expected to stabilize one or multiple levels of the upper airway in patients with obstructive
events or snoring during their physiological sleep. During this assessment, the range of
anteroposterior mandibular movement should be considered to avoid exceeding it during
the DISE, beyond tolerable limits, and thus avoid generating false expectations about the
tolerance and effectiveness of MAD treatment in the studied patient. Furthermore, all levels
of the upper airway should be explored, and the response to mandibular advancement
at each level should be evaluated [33]. In this regard, optimizing and standardizing the
mandibular advancement maneuver during a DISE to eliminate inter-examiner bias is
desirable. Since its inception, manual mandibular traction maneuvers, simulation bites, or
provisional devices that mimic the effect of MADs during a DISE have been proposed to
predict the individual response in the patient [32] (Table 1).

Table 1. Publications with mandibular advancement simulation using different jaw advancement
maneuvers during Drug-Induced Sleep Endoscopy (modified from reference [32]).

AUTHOR YEAR n MANEUVER

Johal et al. [34] 2005 19 Manual advancement maneuver and mad in situ
4–5 mm advancement maneuver performed by the
Johal et al. [35] 2007 120
anesthesiologist
Vroegop et al. and Vanderveken et al. [36] 2013 200 Simulation bite
De Corso et al. [37] 2015 65 Less than 5 mm manual advancement maneuver
Huntley et al. [38] 2018 20 Manual advancement maneuver
Beelen et al. [39] 2018 200 Manual advancement maneuver (jaw thrust)
Kastoer et al. [40] 2018 10 Remotely controlled mandibular positioner
Modified mandibular advancemen maneuver. 50–75%
Park et al. [41] 2019 40
manual advancement
Carrasco et al. [42] 2019 - Modified Esmarch maneuver
Vonk et al. [43] 2020 63 Manual advancement maneuver and boil and bite mad
Cavaliere et al. [44] 2020 66 Simulation bite
Koutsourelakis et al. [45] 2021 49 Manual advancement maneuver
Veugen et al. [46] 2021 70 Manual advancement maneuver
Kazemeini et al. [47] 2022 10 Remotely controlled mandibular positioner
Bosschieter et al. [48] 2022 94 Manual advancement maneuver and boil and bite mad
Fernández-Sanjuán et al. [49] 2022 161 Mandibular titratable positioner (SAM)
Van den Bossche et al. [50] 2023 56 Manual advancement maneuver and mad in situ

According to some publications [36,41,50], performing manual maneuvers is not

considered an appropriate technique for selecting patients eligible for MAD therapy, as it
J. Clin. Med. 2024, 13, 1184 4 of 14

may lead to awakenings during the DISE and may not accurately replicate the real effect of
a MAD.
The aim of the present study is to objectively evaluate modifications in the collapsibility
of the upper airway during a DISE with a stable, titratable, and reproducible maneuver
that mimics the effect of a MAD [49].

2. Materials and Methods

2.1. Participants
A prospective observational descriptive study was designed, including patients diag-
nosed with snoring and OSA from the Otorhinolaryngology and Dental Sleep Medicine
departments of the University Hospitals of Fuenlabrada, Fundación Jiménez Díaz, and La
Zarzuela in Madrid, Spain.
The Medical Ethics Committee of the Hospital Universitario de Fuenlabrada approved
the study protocol in accordance with the Declaration of Helsinki (APR 20/30), and signed
informed consent was obtained from all participants. Data on the study subjects were
collected and stored anonymously to protect personal information.
The sample comprised 104 patients who met the following inclusion and exclusion
criteria. The inclusion criteria were the following: age over 18 years; a diagnosis of simple
snoring or OSA; complete otorhinolaryngological history and examination, including an
upper airway endoscopy while awake during an office visit; complete dental history;
and signed consent. Exclusion criteria were prior surgery for OSA, propofol allergy, an
insufficient number of teeth or poor periodontal health, severe temporomandibular joint
pathology, mandibular anteroposterior movement < 5 mm, craniofacial abnormalities,
or treatment with muscle relaxants. The sample size was calculated using the G*Power
program (Version 3.1.9.6) [51]. Based on the effect sizes available in the literature and a
pilot study, a group of 100 participants was estimated to achieve a contrast power of 80%
with a 95% confidence level.

2.2. Procedure
Patient history was collected, including sociodemographic data: age, sex, and bio-
metric data such as weight, height, and BMI. All patients were evaluated using standard
overnight polysomnography, interpreted according to the criteria established by the Ameri-
can Academy of Sleep Medicine (2011) and a level 2 respiratory polygraphy with cardiac
and respiratory variables analysis. In all cases, the AHI was determined while considering
the number of apneas and hypopneas per hour.
All subjects underwent a DISE according to the protocol established in the European
position paper [30] with the participation of an anesthesiologist, an otorhinolaryngologist,
and a dentist. Standard monitoring was performed, and continuous propofol infusion at
2% with a target concentration of 2 ng/mL was used, with progressive increases of 0.2
to 0.5 ng/mL when required to maintain the desired sedation level. The sedation level
was monitored using the Bispectral Index (BIS) (BIS Quatro® , Covidien ILc, Mansfield,
MA, USA) to maintain the BIS levels between 50 and 70. Vasoconstrictors and topical
anesthetics were not used. The video-flexible endoscope (MACHIDA ENT-30PIII, Chiba,
Japan) was introduced and positioned in the nasopharynx, where the otorhinolaryngologist
waited for the appearance and visualization of two cycles of snoring, apnea, and breathing.
Then, the upper airway was examined up to the larynx. The VOTE scale, as described
by Kezirian et al. [52], was used to assess the degree of collapses at different levels. This
classification defines the collapses with a number: 0, no obstruction (no vibration); 1, partial
obstruction (vibration); and 2, complete obstruction (collapse). Regarding the levels of
collapse, four levels are studied: the velopharynx (V), oropharynx (O), base of the tongue
(T), and epiglottis (E). Measurements were taken twice during the DISE: first, during the
baseline condition without any device for simulation of MAD treatment, then when the
device for advancing the mandible and simulating a MAD treatment was introduced in
the mouth. The progressive jaw advancement was produced following the DISE-SAM
 classification defines the collapses with a number: 0, no obstruction (no vibration); 1, par-
tial obstruction (vibration); and 2, complete obstruction (collapse). Regarding the levels of
collapse, four levels are studied: the velopharynx (V), oropharynx (O), base of the tongue
(T), and epiglottis (E). Measurements were taken twice during the DISE: first, during the
J. Clin. Med. 2024, 13, 1184 baseline condition without any device for simulation of MAD treatment, then when the
5 of 14
device for advancing the mandible and simulating a MAD treatment was introduced in
the mouth. The progressive jaw advancement was produced following the DISE-SAM
[49]. A A
protocol [37,48]. second
secondmeasure
measureusing
usingthe
theVOTE
VOTEscale
scalewas
wastaken
taken (with-SAM condition)
(with-SAM condition)
(see Figure
(see Figure 1).
1).

Figure
Figure 1.
1. Study
Study flowchart.
flowchart.

For simulating
simulatingMAD MADtreatment,
treatment, a SAM
a SAM device
device waswasusedused
that that was specifically
was specifically de-
designed
signed for this purpose [48]. It is a titratable tool that allows the operator
for this purpose [49]. It is a titratable tool that allows the operator perform controlled maneu- perform con-
trolled
vers withmaneuvers with (in
high precision high theprecision
mm range) (in during
the mma DISE,
range)starting
duringfroma DISE, starting from a
a neutral/retrusive
neutral/retrusive
position to reach the position
optimal to reach
positionthewhere,
optimal position
if the patientwhere, if theapnea/snoring
responds, patient responds, are
apnea/snoring
eliminated (Video are eliminated
S1). The device (Videoconsists
S1). Theofdevice consists
two parts: of two parts:
a reusable bodyaandreusable body
single-use
and
trayssingle-use traysinto
to be inserted to be theinserted
patient’sinto the patient’s
mouth. The trays mouth.
can beThe trays can
inserted be inserted
or removed or
inde-
removed
pendentlyindependently
of the device’s of the facilitating
body, device’s body, mouthfacilitating
insertionmouth insertion
or removal at any ortime.
removal at
Before
any time. Before sedating the patient, the SAM device was personalized to the patient’s
sedating the patient, the SAM device was personalized to the patient’s dental arches using
polyvinylsiloxane
dental arches usingdental impression material
polyvinylsiloxane (Video S2).material
dental impression The patient wasS2).
(Video askedThetopatient
move
the jaw
was askedfreely
to moveforward
the jawandfreely
backward
forward before sleep induction.
and backward The maximum
before sleep induction. The retrusive
max-
movement
imum and maximum
retrusive movementprotrusive
and maximum positions were delimited
protrusive positionsby thedelimited
were operator withby themark-
op-
ers on with
erator a scale to avoid
markers onexceeding
a scale to themavoidduring sedation
exceeding them(Video
duringS3). Once the
sedation upper
(Video S3).airway
Once
wasupper
the studied in thewas
airway baseline
studied condition, the SAM
in the baseline device with
condition, the SAMcustomized
device withtrayscustomized
for dental
trays for dental arches was inserted, and the operator changed the mandible’s position bya
arches was inserted, and the operator changed the mandible’s position by manipulating
manually operated
manipulating knob. The
a manually position
operated can The
knob. be changed
positionascan many times as necessary
be changed as many timeswithoutas
removing the
necessary device
without from thethe
removing patient’s
devicemouth,
from theallowing
patient’sformouth,
the mandibular
allowingposition to be
for the man-
fixed in position
dibular the positionto beof fixed
interest in (Figure 2). The
the position of examination
interest (Figurewas2).conducted in the supine
The examination was
conducted in the supine position rather than in lateral decubitus positions to avoidthat
position rather than in lateral decubitus positions to avoid the potential influence the
changes in
potential body’s position
influence that changesmightinhavebody’son airway
positionmodifications.
might have on airway modifications.

Figure 2. (a) SAM device at maximum comfortable protrusion. (b) Jaw without and with mandibular
Figure 2. (a) SAM device at maximum comfortable protrusion. (b) Jaw without and with mandibular
traction, and visualization of the improvement in collapses on the screen.
traction, and visualization of the improvement in collapses on the screen.

All recorded data were included in a database for subsequent analysis.

2.3. Statistical Analysis

Statistical analyses were performed in three main steps.
J. Clin. Med. 2024, 13, 1184 6 of 14

First, the presence of collapses and their degree (complete: 2; partial: 1; and no collapse:
0) at different levels of the upper airway were analyzed both at baseline (without the SAM
device) and under with-SAM conditions using McNemar’s Z statistic. This analysis was
performed for the whole group of participants.
Then, the participants were divided into four severity groups. A repeated measures
Wilcoxon Z analysis was used with the aim of detecting differences between the VOTE
measures in the baseline condition and the results produced by mandibular advancement
(with-SAM condition) at these four levels of the UA in each of the four severity groups.
Finally, Venn diagrams were employed to study the presence of complete collapses at
the VOTE levels at baseline and under with-SAM conditions. This analysis was performed
separately: first for the whole group and then for the four severity groups.
A significance level of p < 0.05 was set to consider existing differences as significant.
The SPSS statistical software package, version 27, was used for all analyses.

3. Results
The sample consisted of 104 patients, with a mean age of 48.75 ± 11.5 years, and 80.8%
(n = 84) were male. The mean BMI was 27.63 ± 3.75 kg/m2 .
As shown in Table 2 and Figure 3, a change in the patient distribution between the
baseline condition and the with-SAM condition was observed for each of the collapse
degrees and VOTE levels. The percentage of patients with complete collapses decreased at
all upper airway levels (p < 0.001 in all levels), while the percentage of patients without
collapses increased in all four levels as well (p < 0.001 in all levels). Regarding partial
collapses, changes were only detected at the V and O levels (p < 0.001 and p = 0.004,
J. Clin. Med. 2024, 13, x FOR PEER REVIEW
respectively), with no significant changes in the percentage of patients who modified7 their
of 14
collapsibility in T (Z = −0.18; p = 0.86) and E (Z = 1.71; p = 0.09).

Figure3.3. Percentage
Figure Percentageof
of patients
patientswith
with complete
completecollapse,
collapse,partial
partialcollapse,
collapse,or
orno
nocollapse
collapseat
ateach
eachVOTE
VOTE
level in baseline condition and with mandibular advancement simulation using
level in baseline condition and with mandibular advancement simulation using SAM. SAM.

When participants
When participantswere
weresubsequently
subsequentlydivided
dividedinto
intofour
four severity
severity subgroups
subgroupsbased
basedon on
theirAHI
their AHIscores,
scores,the
thefollowing
followingcharacteristics
characteristics were
were obtained
obtained forfor each
each group:
group: simple
simple snor-
snoring
ing with
with AHI AHI
< 4.9<(n4.9 (n =16.3%),
= 17; 17; 16.3%),
mild mild
OSA OSA
with with AHI 5–14.9
AHI 5–14.9 (n 21.2%),
(n = 22; = 22; 21.2%), moderate
moderate OSA
OSA with AHI 15–29.9 (n = 23; 22.1%), and severe OSA with AHI > 30
with AHI 15–29.9 (n = 23; 22.1%), and severe OSA with AHI > 30 (n = 42; 40.4%). (n = 42; 40.4%).
Differenceswere
Differences weredetected
detectedbetween
betweenthe
theVOTE
VOTEmeasures
measuresininthe
the baseline
baseline condition
conditionand and
the
the results produced
producedby bythe
themandibular
mandibular advancement
advancement (with-SAM
(with-SAM condition)
condition) at these
at these four
levels. The results obtained are presented in Table 3 and Figure 4 for the four severity
groups.

Table 3. Changes in the VOTE scale within the four severity groups.

Severity Baseline With SAM Z Wilconxon p

 J. Clin. Med. 2024, 13, 1184 7 of 14

four levels. The results obtained are presented in Table 3 and Figure 4 for the four
severity groups.

Table 2. Changes in the proportion of patients between the baseline condition and the with-SAM
condition for each of the collapse grades and VOTE levels.
V V O O T T E E
Z p Z p Z p Z p
Baseline SAM Baseline SAM Baseline SAM Baseline SAM
Complete
77.9 15.4 8.06 *** 53.8 11.5 6.63 *** 41.3 5.8 6.08 *** 18.3 6.7 3.21 ***
collapse (2)
Partial
15.4 56.7 −5.6 *** 14.4 31.7 −2.92 ** 20.2 21.2 −0.18 ns 20.2 12.5 1.71 ns
collapse (1)
No
6.7 27.9 −4.69 *** 31.7 56.7 −5.1 *** 38.5 73.1 −6 *** 61.5 80.8 −4.26 ***
collapse (0)
100 100 100 100 100 100 100 100
V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis; Z: McNemar’s Z statistic; **: p < 0.01;
***: p < 0.001; ns: not significant.

Table 3. Changes in the VOTE scale within the four severity groups.
Severity Baseline With SAM Z Wilconxon p
V 1.41 0.65 −3.13 ***
O 1.18 0.41 −2.6 ***
Snorers
T 0.53 0.24 −1.63 ns
E 0.47 0.24 −1.63 ns
V 1.81 0.73 −4.02 ***
O 1 0.14 −3.27 ***
Mild OSA T 0.73 0.05 −2.87 **
E 0.27 0.23 −0.27 ns
V 1.7 0.74 −3.95 ***
O 1.13 0.43 −3.36 ***
Moderate OSA T 1.13 0.22 −3.52 ***
E 0.17 0.17 −3 **
V 1.79 1.12 −4.77 ***
O 1.4 0.88 −4.3 ***
Severe OSA T 1.33 0.57 −4.46 ***
ed. 2024, 13, x FOR PEER REVIEW 8 of 14
E 0.76 0.33 −3.45 ***
V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis; **: p < 0.01; ***: p < 0.001; ns: not significant.

Figure 4. Changes in the VOTE levels at baseline and with SAM device within the four severity
Figure 4. Changes in the VOTE levels at baseline and with SAM device within the four severity
groups. V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis; **: p < 0.01; ***: p < 0.001;
groups. V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis; **: p < 0.01; ***: p < 0.001;
ns: not significant.
ns: not significant.
Finally, the presence of complete collapses was studied at all VOTE levels and in all
Finally, the presence of complete collapses was studied at all VOTE levels and in all
possible combinations. This analysis was performed under both baseline and with-SAM
possible combinations. This analysis was performed under both baseline and with-SAM
conditions for the whole group
conditions for theand independently
whole for each severity
group and independently group.
for each The results
severity group. The results are
are displayed indisplayed
Figure 5 (all severity groups) and Figure 6 for each severity group.
in Figure 5 (all severity groups) and Figure 6 for each severity group.
 ns: not significant.

Finally, the presence of complete collapses was studied at all VOTE levels and in all
possible combinations. This analysis was performed under both baseline and with-SAM
J. Clin. Med. 2024, 13, 1184 8 of 14
conditions for the whole group and independently for each severity group. The results
are displayed in Figure 5 (all severity groups) and Figure 6 for each severity group.

Figure 5.
Figure 5. Venn
Venn diagram
diagram illustrating
illustrating the
the presence
presence in
in percentages
percentages of
of complete
complete collapses
collapses at
at different
different
J. Clin. Med. 2024, 13, x FOR PEER REVIEW 9 of 14
VOTE levels and the existence of multilevel complete collapses at baseline and with SAM device in
VOTE levels and the existence of multilevel complete collapses at baseline and with SAM device in
the whole sample (V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis).
the whole sample (V: velopharynx; O: oropharynx; T: base of the tongue; E: epiglottis).

Figure
Figure 6. 6. Venn
Venn diagram
diagram illustrating
illustrating the
the presence
presence in
in percentages
percentages of
of complete
complete collapses
collapses at
at different
different
VOTE levels and the existence of multilevel complete collapses at baseline and with SAM device for
VOTE levels and the existence of multilevel complete collapses at baseline and with SAM device
every severity group independently. (V: velopharynx; O: oropharynx; T: base of the tongue; E: epi-
for every severity group independently. (V: velopharynx; O: oropharynx; T: base of the tongue; E:
glottis).
epiglottis).
4.
4. Discussion
Discussion
MADs
MADs have
have become
become an alternative treatment
an alternative treatment for for patients
patients with
with snoring
snoring and/or
and/or OSA, OSA,
and their use is increasing due to the good results shown in many patients
and their use is increasing due to the good results shown in many patients [8,13,19]; [8,13,19]; how-
ever,
however,as with otherother
as with treatments, the adaptation
treatments, of a MAD
the adaptation is notiseffective
of a MAD in all in
not effective cases since
all cases
the
sinceorigin of OSA
the origin ofisOSA
multifactorial [22]. Moreover,
is multifactorial the usethe
[22]. Moreover, of use
a MAD of a can
MAD lead
cantolead
the wors-
to the
ening
worseningof the
of baseline condition.
the baseline It isItknown
condition. is known that thethe
that greater
greaterthe theseverity,
severity,the
thelower
lower the
the
expected response, but on the other hand, a complete response can be
expected response, but on the other hand, a complete response can be achieved regardless achieved regardless
of
of the
the severity
severity for
for many
many patients
patients [13].
[13].
In the present study, modifications in
In the present study, modifications in the collapsibility of
the collapsibility of the
the UA
UA were
were analyzed
analyzed in in
patients with sleep-disordered breathing
breathing during
during aa DISE
DISE with
with aa titratable
titratableMADMADsimulator,
simulator,
the Selector de Avance
Avance Mandibular
Mandibular (SAM).
(SAM). The The objective
objective evaluation
evaluation of of the
the mandibular
mandibular ad- ad-
vancement simulation
simulationisisexpected
expected toto contribute
contribute to the
to the selection
selection of patients
of patients suitable
suitable for MADfor
MAD treatment or for the selection of a combination of therapies. To the best of our
knowledge, this is the first study to perform an analysis of the changes observed at each
VOTE level, based on the degree of severity of the sleep-disordered breathing, and using
a titratable device. Also, for the first time, UA collapsibility in simple snoring has been
studied during a DISE.
J. Clin. Med. 2024, 13, 1184 9 of 14

treatment or for the selection of a combination of therapies. To the best of our knowledge,
this is the first study to perform an analysis of the changes observed at each VOTE level,
based on the degree of severity of the sleep-disordered breathing, and using a titratable
device. Also, for the first time, UA collapsibility in simple snoring has been studied during
a DISE.
Differing from investigations using imaging tests such as CBCT and CT scans that
focused on examining patients’ UA during wakefulness [23–26,53], in the current study,
modifications were monitored during a DISE which is a validated technique representative
of physiological sleep [29,34,37,54–57]. Our results are in line with other studies that
consider DISE to be a good technique for evaluating the location and pattern of UA
collapses, as well as the capability of mandibular advancement to identify candidates for
MAD treatment [36,43,44,50,56,58].
The initial publications mentioning the utility of DISE for MAD patient selection
described manual maneuvers to mimic the effect of a MAD [34,37]. Today, it is known
that manual maneuvers are discouraged because it may fall short and fail to identify
a potential responder patient. Also, a manual maneuver can produce an exaggerated
response in the hypopharynx that does not correlate with the effect of a MAD; it could
induce arousals, and in addition, the increase in the vertical dimension produced by the
MAD is not considered [30,36,43,49]. To address these issues and standardize the maneuver,
the SAM device allows for the simulation of the effect of a MAD with a reproducible and
quantifiable maneuver that mimics the size of a MAD-eliminating inter-examiner bias.
When analyzed as a group, the present results show that when implementing the
maneuver with the SAM device, there are improvements observed across all levels of the
VOTE scale. Complete collapses decrease, either transforming into partial collapses or
completely disappearing, and there is an increase in the number of levels with no collapses.
With this personalized information, targeted combined therapies could be suggested to
alleviate residual collapses when complete stabilization is not expected. Vroegop et al. [36]
found that in the baseline situation, collapses at the palate level were the most frequent,
followed by at the base of the tongue and epiglottis, while oropharyngeal collapses were
the least frequent. The results of the present study coincide with the observation that as a
group, the level at which collapses most frequently occur in the baseline situation is the
velum; however, it was observed that the next most common level for collapses was the
oropharynx, followed by the base of the tongue and epiglottis.
When the modifications in the different severity groups were analyzed, the present
study revealed that as the severity of the respiratory disorder increases, collapsibility also
increases in the baseline situation at all levels. In snorers, complete collapses were mainly
found in the soft palate and oropharynx. In mild OSA patients, collapses were also present
at the base of the tongue, and in moderate/severe OSA patients, collapses were present at
all levels, including the epiglottis. With the SAM device, an improvement in snorers occurs
in the V and O, so if there is residual snoring despite the use of a MAD, the therapy should
be aimed at alleviating collapses of the velo- or oropharynx. As the severity increases, this
improvement is also observed in the T and E. In other words, the improvement offered by
a MAD could occur at all levels and across different severity groups. In moderate/severe
OSA patients, residual collapses can be present at any level, hence the importance of an
examination under induced sleep to better direct patients’ therapy in more severe groups
as it allows for a personalized approach.
As in other studies, an analysis of the presence and modifications in multilevel col-
lapses was conducted. All isolated and multilevel collapses improved with the use of the
SAM device except for some related to the E. In the supine position, secondary epiglottal
collapses at the base of the tongue improved when the tongue improved with the use of a
MAD in all severity groups. When the collapse was primary, it only improved in snorers in
50% of the patients who used the SAM device; however, it did not improve in mild and
severe cases. Additionally, there is a small group of patients (2.4%) in whom mandibular
advancement can cause deterioration at this level. This suggests that mandibular advance-
J. Clin. Med. 2024, 13, 1184 10 of 14

ment not only does not improve some collapses of the E but can also cause the epiglottis
to collapse when it does not in the baseline situation. This finding can explain the deteri-
oration for some patients when using a MAD in the supine position. For these patients,
evidence shows that this epiglottal collapse could be treated with positional therapy [59].
When studying multilevel collapses, Vroegop et al. [36] noted frequent combinations of
collapse levels, with the most common collapse pattern being a combination of palatal
and base-of-tongue collapses (34.4%). In our study, multilevel collapses were also studied,
with the velum and oropharynx being the most common (20.2%), followed by the velum,
oropharynx, and base-of-tongue collapse (14.4%). It should be noted that our sample
included snoring patients (16.3% of the patients), which could influence the results as they
showed more collapsibility at the velo- and oropharynx at baseline. Using the SAM device,
a considerable decrease in the number of patients with multilevel collapses (combinations
of two, three, and four collapses) was observed. Only 5.8% exhibited complete collapses
at all levels, which reduced to 1% of patients in whom no complete collapse was resolved
using the SAM device. Cavaliere et al. [44], using a comfortable maximum protrusion bite,
found combined collapses in 65% of the patients. In the present study, the presence of
combined collapses in the baseline situation was 60.6%, slightly lower possibly due to the
inclusion of snorers in our study. With the use of the SAM device in situ, the combined
collapses decreased to 11.6%. This suggests that if a MAD cannot be used as a sole treat-
ment, it could still be an important tool for combined therapy by contributing to the relief
of collapsibility at all levels. In addition, for the first time, a combination of collapses was
analyzed by severity group independently, with the most frequent combination being the
V-O in snorers and mild and moderate OSA patients, and a combination of V-O-T in severe
OSA patients.
In the present study, as a group, the levels responsible for residual complete collapses
that could be responsible for a poor response are, in order, V, O, E, and T, and, to a lesser
extent, persistent multilevel collapses; however, when analyzed by severity groups, the
most frequent residual complete collapses that occurred in snorers were in the V and O, and
in the combination of the V-O and V-E. In mild OSA patients, this was observed in E and the
combination of V-E, while in moderate cases, it occurred in the V and O. For severe cases,
the highest magnitude of residual complete collapses was seen in the V, O, T, and E, as well
as in the combination of V-O and V-O-T (see Figure 5). Similarly, Vonk et al. [43] observed,
using a provisional MAD, that the group of patients identified as unsuitable candidates
was due to residual complete retropalatal collapses, residual complete hypopharyngeal
collapses, and, to a lesser extent, persistent multilevel collapses.
One of the strengths of this study is the ability to standardize the mandibular ad-
vancement simulations, with the option to customize it by using a titratable device. Until
now, provisional devices with a single position to explore have been employed. This
feature can help identify potential deteriorations in collapsibility, such as what may occur
at the epiglottis for some patients when inducing larger advancements. Among the study
limitations, it should be noted that the examinations were performed at different centers
following European consensus recommendations on DISEs to standardize criteria. The
same dentist was always present, performing the mandibular advancement maneuvers, but
different otolaryngologists and anesthesiologists with extensive experience in the technique
participated. Secondly, the assessment of baseline collapsibility as well as the modifications
resulting from the incorporation of the SAM device is subjective, and there may be some
inter-examiner variability. Lastly, it should be noted that these sedations were carried out
with propofol, so REM sleep cannot be visualized.

5. Conclusions
The MAD simulator allows for the objective assessment of modifications in the upper
airway in sedated patients. A reduction in collapsibility at all levels of the UA is observed
and in all severity groups, leading to a general decrease in the number of complete collapses.
This procedure could detect residual collapses, making it possible to identify patients
J. Clin. Med. 2024, 13, 1184 11 of 14

suitable for combined treatments. To summarize, in snoring and mild OSA patients,
a combination of therapies could be employed to alleviate collapses of the soft palate
and oropharynx, and in more severe OSA patients, a combination of therapies aimed
at any level should be considered, hence the importance of a personalized study under
sedation. The levels primarily associated with residual collapses despite the use of the
MAD simulator are the velopharynx and oropharynx, followed by the epiglottis and tongue.
It is worth noting that in some cases, the use of a MAD could cause primary collapses of
the epiglottis in the supine position, which could result in deterioration compared to the
baseline. This highlights the need for individualized patient selection, as upper airway
collapsibility exhibits variable improvement or worsening with MAD simulation regardless
of the severity.

Supplementary Materials: The following supporting information can be downloaded at: https:
//www.mdpi.com/article/10.3390/jcm13051184/s1, Video S1: Titratable tool. Video S2: Personalized
jaw opening. Video S3: Maximum retrusive movement and maximum protrusive positions.
Author Contributions: Conceptualization, P.F.-S., J.J.A., M.A., and G.P.; methodology, P.F.-S., M.A.,
G.B., N.P.-M., M.M., and G.P.; validation, R.L., J.S., and G.P.; formal analysis, G.P. and M.R.-L.;
investigation, P.F.-S.; resources, P.F.-S.; data curation, P.F.-S., M.A., G.B., N.P.-M., M.M., and G.P.;
writing—original draft preparation, P.F.-S. and G.P.; writing—review and editing, P.F.-S., M.R.-L., and
G.P.; supervision, G.P. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The Medical Ethics Committee of the Hospital Universitario
de Fuenlabrada approved the study protocol in accordance with the Declaration of Helsinki on
September 2020 (APR 20/30). Data on study subjects were collected and stored anonymously to
protect personal information.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: Data are contained within the article.
Conflicts of Interest: Patricia Fernández-Sanjuán is the creator of the SAM device. The other authors
declare no conflicts of interest regarding the publication of this paper.

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