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Introduction: Custom-made titratable mandibular advancement device (MAD) treatment can nowadays be considered a promising first-line treatment in patients with mild to severe obstructive sleep apnea (OSA). Specific manufacturing designs and titration mechanisms of MAD are on the market, characterized by their titration approach, vertical opening, and materials selection. The wing-designed MAD (SomnoDent® Flex™, SomnoMed Ltd, Sydney, Australia) has a lateral screw mechanism to advance the lower jaw in incremental steps of 0.1 up to 6.0 mm. The newer uniquely designed custom-made MAD with passive mouth closing (SomnoDent® Avant™ SomnoMed Ltd, Sydney, Australia) has a frontal exchangeable advancement strap of fixed lengths as a specific titration mechanism, all supporting freedom of lateral movement. We aimed to assess the associations between the type of MAD prescribed and OSA treatment outcome., Methods: Data from 209 patients (165 male, mean age 53.9 (±10.9) years, median baseline BMI and AHI 27.02 [24.8; 29.7] kg/m 2 and 22.8 [17.7; 31.6]/hour sleep, respectively) were collected. Of this cohort, 91 patients with the traditional, wing-based SomnoDent® Flex™ and 118 patients with SomnoDent® Avant™. All patients were diagnosed with a type 1 polysomnography demonstrating moderate to severe OSA (15 ≤ AHI ≤65 per hour sleep). The selected MAD was fitted in the so-called maximal comfortable protrusion. After 3 months of subjective titration until resolution of subjective symptoms and/or achieving physical limits, a checkup with validated home sleep monitoring was conducted. Treatment success was defined as "AHI reduction ≥50% with MAD compared to baseline AHI and AHI with MAD <10 events per hour"., Results: These real-world data set showed that 67% of patients achieved treatment success, with a statistically significant reduction in AHI from 22.8 [17.7; 31.6] to 7.45 [3.4; 15.0]/h sleep. The SomnoDent® Avant™ achieved 75% treatment success versus 56% for the traditional, wing-based SomnoDent® Flex™ (P < 0.05). Overall, AHI reduction was 70% for SomnoDent® Avant™ (P < 0.05) vs. 63% for SomnoDent® Flex™ (P < 0.05)., Conclusions: This study shows that choice of MAD design can impact the treatment outcome and could become an important consideration in selecting the type of MAD for personalized treatment for OSA patients. While the results of the traditional wing-based MAD design were comparable to the therapeutic outcome with other titratable, custom-made MADs, the MAD with the passive mouth closing feature showed significantly greater reduction in total AHI potentially due to encouraged nasal breathing, reduced mouth breathing and lesser vertical opening thereby decreasing the probability of tongue base collapse., Competing Interests: Declaration of competing interest These authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Olivier M. VANDERVEKEN reports a relationship with SomnoMed that includes: board membership and funding grants. Olivier M VANDERVEKEN reports a relationship with ProSomnus that includes: funding grants and speaking and lecture fees. Olivier M VANDERVEKEN reports a relationship with Inspire Medical Systems Inc that includes: consulting or advisory and funding grants. Olivier M VANDERVEKEN reports a relationship with Nyxoah SA that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Verbraecken Johan reports financial support was provided by Somnomed. Verbraecken Johan reports financial support was provided by Air Liquide SA. Verbraecken Johan reports financial support was provided by Atos Medical AB. Verbraecken Johan reports financial support was provided by Vivisol NL. Verbraecken Johan reports financial support was provided by Mediq BV. Verbraecken Johan reports financial support was provided by Medidis. Verbraecken Johan reports financial support was provided by Micromed OSG. Verbraecken Johan reports financial support was provided by Bioprojet. Verbraecken Johan reports financial support was provided by Desitin Pharmaceuticals. Verbraecken Johan reports financial support was provided by Epilog. Verbraecken Johan reports financial support was provided by Idorsia Pharmaceuticals Ltd. Verbraecken Johan reports financial support was provided by Koninklijke Philips. Verbraecken Johan reports financial support was provided by ResMed. Verbraecken Johan reports financial support was provided by Inspire Medical Systems Inc. Verbraecken Johan reports financial support was provided by Lowenstein Medical Technology LLP. Verbraecken Johan reports financial support was provided by Ectosense. Verbraecken Johan reports financial support was provided by ProSomnus. Verbraecken Johan reports financial support was provided by Sefam. Verbraecken Johan reports was provided by SD Worx. Verbraecken Johan reports financial support was provided by DEME. Verbraecken Johan reports financial support was provided by SOS Oxygène. Verbraecken Johan reports financial support was provided by Tilman S.A. Verbraecken Johan reports financial support was provided by Total Care. Verbraecken Johan reports financial support was provided by Ministry of the Flemish Community. Verbraecken Johan reports financial support was provided by Vlerick Business School. Verbraecken Johan reports financial support was provided by Itamar-Medical Inc. Verbraecken Johan reports a relationship with Bioprojet that includes: board membership, consulting or advisory, speaking and lecture fees, and travel reimbursement. Verbraecken reports a relationship with Epilog that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. These authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper: Margot VAN DAELE declares that she has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Marc BRAEM declares that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Marijke DIELTJENS declares that she has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objective: To quantitatively investigate the effect of mandibular advancement devices (MADs) on pharyngeal airway dimensions in a transverse plane as measured during drug-induced sleep endoscopy (DISE)., Methods: Data from 56 patients, treated with MAD at 75% maximal protrusion and with baseline Apnea-Hypopnea Index ≥10 events/h, were analyzed. For each patient, three snapshots were selected from DISE video footage at baseline, with MAD presence, and during chin lift, resulting in 498 images (168/168/162, baseline/MAD/chin lift). Cross-sectional areas, anteroposterior (AP) and laterolateral (LL) dimensions on both retroglossal and retro-epiglottic levels were measured. To define the effect of MAD and chin lift on pharyngeal dimensions, linear mixed-effect models were built. Associations between MAD treatment response and pharyngeal expansion (MAD/chin lift) were determined., Results: Significant differences were found between retroglossal cross-sectional areas, AP, and LL dimensions at baseline and with MAD presence. At a retro-epiglottic level, only LL dimensions differed significantly with MAD presence compared to baseline, with significant relation of LL expansion ratio to treatment response (p = 0.0176). After adjusting the response definition for the sleeping position, greater retroglossal expansion ratios were seen in responders (1.32 ± 0.48) compared to non-responders (1.11 ± 0.32) (p = 0.0441). No significant association was found between response and pharyngeal expansion by chin lift., Conclusion: Our observations highlight the additional value of quantitative pharyngeal airway measurements during DISE with MAD presence in evaluating MAD treatment outcome. These findings demonstrate an increase in retroglossal airway dimensions during DISE, with MAD presence, and more pronounced increase in retroglossal expansion ratios in MAD treatment responders compared to non-responders after sleeping position correction., Level of Evidence: 3 Laryngoscope, 133:3619-3627, 2023., (© 2023 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Study Objectives: Treatment-emergent central sleep apnea (TECSA) describes the appearance or persistence of central sleep apnea while undergoing treatment for obstructive sleep apnea. TECSA is well studied in continuous positive airway pressure therapy with an estimated prevalence of 8%. Based on a few case reports, mandibular advancement devices (MAD) may also provoke TECSA. This study aims to gain insight into the prevalence of TECSA with MAD therapy., Methods: This retrospective study includes a total of 129 patients with moderate to severe obstructive sleep apnea who were treated with a custom-made titratable MAD. Baseline and follow-up sleep studies were compared to identify patients with TECSA. Since different diagnostic criteria to define TECSA are used in literature, prevalence was calculated according to three definitions (TECSA-1, -2, and -3). Demographics, MAD treatment variables, and findings of the diagnostic polysomnography were compared between TECSA and non-TECSA patients to identify possible predictors., Results: Depending on the definition used, TECSA was found in 3.1%-7.8% of patients undergoing MAD therapy. TECSA patients had a higher apnea index (9.2 vs 2.0 events/h, P = .042), central apnea-hypopnea index (4.1 vs 0.2 events/h, P = .045) and oxygen desaturation index (23.9 vs 16.3 events/h, P = .018) at baseline compared to non-TECSA patients. No differences were found in demographics and treatment variables., Conclusions: These findings demonstrate that TECSA also occurs in patients starting MAD treatment. Patients with TECSA had a higher apnea index, central apnea-hypopnea index, and oxygen desaturation index at baseline compared to non-TECSA patients., Citation: Hellemans S, Van de Perck E, Braem MJ, Verbraecken J, Dieltjens M, Vanderveken OM. The prevalence of treatment-emergent central sleep apnea with mandibular advancement device therapy. J Clin Sleep Med . 2023;19(12):2035-2041., (© 2023 American Academy of Sleep Medicine.)

Mandibular advancement device (MAD) treatment outcome for obstructive sleep apnea (OSA) is variable and patient dependent. A global, clinically applicable predictive model is lacking. Our aim was to combine characteristics obtained during drug-induced sleep endoscopy (DISE), awake nasendoscopy, and computed tomography scan-based computational fluid dynamic (CFD) measurements in one multifactorial model, to explain MAD treatment outcome. A total of 100 patients with OSA were prospectively recruited and treated with a MAD at fixed 75% protrusion. In all, 72 underwent CFD analysis, DISE, and awake nasendoscopy at baseline in a blinded fashion and completed a 3-month follow-up polysomnography with a MAD. Treatment response was defined as a reduction in the apnea-hypopnea index (AHI) of ≥50% and deterioration as an increase of ≥10% during MAD treatment. To cope with missing data, multiple imputation with predictive mean matching was used. Multivariate logistic regression, adjusting for body mass index and baseline AHI, was used to combine all potential predictor variables. The strongest impact concerning odds ratios (ORs) was present for complete concentric palatal collapse (CCCp) during DISE on deterioration (OR 28.88, 95% confidence interval [CI] 1.18-704.35; p = 0.0391), followed by a C-shape versus an oval shape of the soft palate during wakefulness (OR 8.54, 95% CI 1.09-67.23; p = 0.0416) and tongue base collapse during DISE on response (OR 3.29, 95% CI 1.02-10.64; p = 0.0464). Both logistic regression models exhibited excellent and fair predictive accuracy. Our findings suggest DISE to be the most robust examination associated with MAD treatment outcome, with tongue base collapse as a predictor for successful MAD treatment and CCCp as an adverse DISE phenotype., (© 2022 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Study Objectives: The aim of this pilot study was to evaluate the clinical effectiveness of subjective titration versus objectively guided titration during polysomnography (PSG) and drug-induced sleep endoscopy (DISE) in mandibular advancement device (MAD) therapy for patients with obstructive sleep apnea (OSA)., Methods: In this pilot cross-over study, patients underwent three titration procedures in randomized order: (1) subjective titration, (2) PSG-guided titration using a remotely controlled mandibular positioner (RCMP) and (3) DISE-assisted titration using RCMP. After each titration procedure, patients used the MAD for 1 month at the targeted protrusion obtained according to the preceding titration procedure. For each procedure, a follow-up PSG was performed after 1 month of MAD use in order to evaluate the efficacy of the MAD., Results: Ten patients were included in the study. Overall, no significant differences in targeted optimal protrusion compared to maximal comfortable protrusion among the three titration methods were observed. There was no significant difference in reduction in AHI. In this study, PSG titration correctly classified 50% of patients as 'responder'. A higher predictive accuracy was found for DISE titration with a sensitivity of 83.3% and a specificity of 100%., Conclusions: This pilot randomized cross-over trial showed no differences in optimal mandibular positioning and corresponding efficacy of MAD between subjective titration, DISE titration or PSG titration., (© 2022. The Author(s).)

Study Objectives: Mandibular advancement devices (MADs) are a noninvasive treatment option for patients with obstructive sleep apnea (OSA) and act by increasing the upper airway volume. However, the exact therapeutic mechanism of action remains unclear. The aim of this study was to assess MAD mechanisms using functional imaging that combines imaging techniques and computational fluid dynamics and assess associations with treatment outcome., Methods: One hundred patients with OSA were prospectively included and treated with a custom-made MAD at a fixed 75% protrusion. A low-dose computed tomography scan was made with and without MADs for computational fluid dynamics analysis. Patients underwent a baseline and 3-month follow-up polysomnography to evaluate treatment efficacy. A reduction in apnea-hypopnea index ≥ 50% defined treatment response., Results: Overall, 71 patients completed both 3-month follow-up polysomnography and low-dose computed tomography scan with computational fluid dynamics analysis. MAD treatment significantly reduced the apnea-hypopnea index (16.5 [10.4-23.6] events/h to 9.1 [3.9-16.4] events/h; P < .001, median [quartile 1-quartile 3]) and significantly increased the total upper airway volume (8.6 [5.4-12.8] cm 3 vs 10.7 [6.4-15.4] cm 3 ; P = .003), especially the velopharyngeal volume (2.1 [0.5-4.1] cm 3 vs 3.3 [1.8-6.0] cm 3 ; P < .001). However, subanalyses in responders and nonresponders only showed a significant increase in the total upper airway volume in responders, not in nonresponders., Conclusions: MAD acts by increasing the total upper airway volume, predominantly due to an increase in the velopharyngeal volume. Responders showed a significant increase in the total upper airway volume with MAD treatment, while there was no significant increase in nonresponders. Findings add evidence to implement functional imaging using computational fluid dynamics in routine MAD outcome prediction., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT01532050; Identifier: NCT01532050., Citation: Van Gaver H, Op de Beeck S, Dieltjens M, et al. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022;18(3):739-750., (© 2022 American Academy of Sleep Medicine.)

Study Objectives: Obstructive sleep apnea (OSA) is associated with cardiovascular comorbidities such as left ventricular (LV) hypertrophy. Whether OSA is an independent etiological factor for this hypertrophic remodeling is yet unknown. Continuous positive airway pressure partially reverses this hypertrophy, but data regarding the effect of mandibular advancement devices on LV remodeling are scarce. The aim of this prospective trial is to evaluate the effect of mandibular advancement device therapy on LV geometry and function in patients with OSA., Methods: At baseline and 6-month follow-up, participants underwent a home sleep apnea test, 24-hour ambulatory blood pressure monitoring and a 2-dimensional Doppler and tissue Doppler echocardiography., Results: Sixty-three patients (age: 49 ± 11 years; body mass index: 27.0 ± 3.4 kg/m 2 ; baseline apnea-hypopnea index home sleep apnea test: 11.7 [8.2; 24.9] events/h) completed the 6-month follow-up visit. Overall, blood pressure values and parameters of LV function were within normal ranges at baseline and did not change under mandibular advancement device therapy. In contrast, the interventricular septum thickness was at the upper limits of normal at baseline and showed a significant decrease at 6-month follow-up (11.1 ± 2.1 mm vs 10.6 ± 2.0 mm, P = .03). This significant improvement is only found in responders but not in nonresponders. There was no correlation between the decrease of interventricular septum thickness and the change in blood pressure., Conclusions: In mildly obese, normotensive patients with OSA we observed significant reverse hypertrophic remodeling after 6 months of successful mandibular advancement device therapy, with maintained normotensive systemic blood pressure. This suggests that OSA is an independent factor in the pathophysiology of LV hypertrophy in these patients., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02320877; Identifier: NCT02320877., Citation: Dieltjens M, Vanderveken OM, Shivalkar B, et al. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea. J Clin Sleep Med . 2022;18(3):903-909., (© 2022 American Academy of Sleep Medicine.)

Rationale: Mandibular advancement device (MAD) treatment efficacy varies among patients with obstructive sleep apnea. Objectives: The current study aims to explain underlying individual differences in efficacy using obstructive sleep apnea endotypic traits calculated from baseline clinical polysomnography: collapsibility (airflow at normal ventilatory drive), loop gain (drive response to reduced airflow), arousal threshold (drive preceding arousal), compensation (increase in airflow as drive increases), and the ventilatory response to arousal (increase in drive explained by arousal). On the basis of previous research, we hypothesized that responders to MAD treatment have a lower loop gain and milder collapsibility. Methods: Thirty-six patients (median apnea-hypopnea index [AHI], 23.5 [interquartile range (IQR), 19.7-29.8] events/h) underwent baseline and 3-month follow-up full polysomnography, with MAD fixed at 75% of maximal protrusion. Traits were estimated using baseline polysomnography according to Sands and colleagues. Response was defined as an AHI reduction ≥ 50%. Results: MAD treatment significantly reduced AHI (49.7% baseline [23.9-63.6], median [IQR]). Responders exhibited lower loop gain (mean [95% confidence interval], 0.53 [0.48-0.58] vs. 0.65 [0.57-0.73]; P  = 0.020) at baseline than nonresponders, a difference that persisted after adjustment for baseline AHI and body mass index. Elevated loop gain remained associated with nonresponse after adjustment for collapsibility (odds ratio, 3.03 [1.16-7.88] per 1-standard deviation (SD) increase in loop gain [SD, 0.15]; P  = 0.023). Conclusions: MAD nonresponders exhibit greater ventilatory instability, expressed as higher loop gain. Assessment of the baseline degree of ventilatory instability using this approach may improve upfront MAD treatment patient selection.Clinical trial registered with www.clinicaltrials.gov (NCT01532050).

Objectives: Awake nasopharyngoscopy is routinely performed in the assessment of patients who require treatment for sleep-disordered breathing (SDB). However, the applicability and accuracy of Müller's manoeuvre, the main evaluation method for this purpose, are disputable. The current study aimed to introduce an alternative method for awake nasopharyngoscopy in patients with SDB., Design: We defined qualitative anatomical features during tidal breathing at the levels of the soft palate, oropharynx, tongue base, epiglottis and hypopharynx, and compared these awake features to the sites and patterns of collapse as observed during drug-induced sleep endoscopy (DISE)., Setting: Tertiary care academic centre., Participants: Seventy-three patients diagnosed with SDB., Main Outcome Measures: The primary outcome measure was the Kendall's tau correlation coefficient (τ) between observations during awake nasopharyngoscopy and DISE. Kappa-statistics (κ) were calculated to assess the agreement on awake endoscopic features with a second observer., Results: In contrast to epiglottis shape, the modified Cormack-Lehane scale was significantly associated with epiglottis collapse during DISE (P < .0001; τ = .45). Other upper airway features that were correlated with DISE collapse were the position of the soft palate (P = .007; τ = .29), crowding of the oropharynx (P = .026; τ = .32) and a posteriorly located tongue base (P = .046; τ = .32). Interobserver agreement of endoscopic features during tidal breathing was moderate (0.60 ≤ κ < 0.80)., Conclusion: The current study introduces a comprehensive and reliable assessment method for awake nasopharyngoscopy based on anatomical features that are compatible with DISE collapse patterns., (© 2020 John Wiley & Sons Ltd.)

Study Objectives: The variable efficacy of mandibular advancement device (MAD) treatment necessitates both accessible and accurate methods for patient selection. However, the role of awake nasopharyngoscopy for this purpose remains dubious. We introduced an assessment method based on anatomical upper airway features during tidal breathing for nasopharyngoscopy. The current study aimed to relate these features to MAD treatment outcome., Methods: One hundred patients diagnosed with obstructive sleep apnea were prospectively recruited for MAD treatment in a fixed 75% degree of maximal protrusion. Nasopharyngoscopic observations during Müller's maneuver and tidal breathing were recorded both with and without MAD. Treatment outcome, confirmed by 3-month follow-up polysomnography with MAD, was classified as (1) apnea-hypopnea index reduction ≥ 50%, (2) treatment apnea-hypopnea index < 5 events/h, and (3) ≥ 10% increase in apnea-hypopnea index compared with baseline (treatment deterioration)., Results: A complete dataset was obtained in 65 patients. After adjusting for baseline apnea-hypopnea index, body mass index, and supine dependency, the position of the soft palate (odds ratio, 4.0; 95% confidence interval, 1.3-11.8; P = .013) and crowding of the oropharynx (odds ratio, 7.7; 95% confidence interval, 1.4-41.4; P = .017) were related to treatment deterioration. Addition of both features significantly (P = .031) improved the accuracy of baseline models based on clinical measurements alone. Moreover, with the MAD in situ, a posteriorly located soft palate (odds ratio, 9.8; 95% confidence interval, 1.7-56.3; P = .010) and a posteriorly located tongue base (odds ratio, 7.4; 95% confidence interval, 1.5-35.9; P = .013) were associated with treatment deterioration., Conclusions: Awake nasopharyngoscopy might be a valuable office-based examination to exclude the risk of treatment deterioration and improve patient selection for MAD treatment., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea (PROMAD); URL: https://clinicaltrials.gov/ct2/show/NCT01532050; Identifier: NCT01532050., (© 2020 American Academy of Sleep Medicine.)

Objectives/hypothesis: To evaluate upper airway (UA) collapse patterns during drug-induced sleep endoscopy (DISE) and maxillomandibular advancement (MMA) surgery outcome, paying particular attention to the DISE phenotype complete concentric collapse at the level of the palate (CCCp)., Study Design: Prospective case series., Methods: Nineteen patients diagnosed with obstructive sleep apnea (OSA) prospectively underwent mandibular advancement device (MAD) treatment followed by MMA surgery. UA collapse patterns were evaluated before and after MMA surgery. Baseline apnea-hypopnea index (AHI) was compared with AHI during MAD treatment and after MMA surgery. UA collapse patterns and the presence of baseline CCCp were assessed. AHI differences between patients with and without CCCp after MMA surgery were compared., Results: In 14 patients, a full dataset was obtained: 8/6 (male/female), mean age = 51 ± 7 years, body mass index (BMI) = 25.6 ± 3.7 kg/m 2 , and baseline AHI = 40.2 ± 25.6 per hour of sleep. MMA surgery reduced AHI to 9.9 ± 7.2 per hour of sleep (P = .0001). Eight patients benefited from additional AHI reduction compared to MAD treatment (P = .0113). Six out of 14 (43%) patients showed baseline CCCp. Baseline patient characteristics (age, BMI, and AHI) did not significantly differ between patients with and without CCCp. AHI was equally reduced after MMA, whether (P = .0145) or not (P = .0075) CCCp was present at baseline. All patients showed resolution of CCCp (P = .0159) during postoperative DISE., Conclusions: CCCp seems not to be a negative predictor for MMA surgery outcome measured by AHI reduction. Furthermore, MMA is likely to eliminate CCCp. Therefore, MMA might be a solution for OSA patients showing CCCp and broadens the perspective for personalized medicine and combination therapy. However, a large sample is required for definitive results., Level of Evidence: 4 Laryngoscope, 130:E268-E274, 2020., (© 2019 The American Laryngological, Rhinological and Otological Society, Inc.)

Purpose: The aim of the present study was to assess the efficacy of a sleep position trainer (SPT) in patients with an established diagnosis of positional obstructive sleep apnea and to evaluate the adherence after 1-year follow-up., Methods: Polysomnography (PSG) was performed at baseline and after 1 year of SPT use. Patients received questionnaires to assess treatment satisfaction and subjective adherence. Data on objective adherence and number of vibrations initiated by the SPT were collected from the SPT device., Results: Nine out of 58 patients stopped using the SPT during the first year of treatment (16%). Thirty-four middle-aged and overweight patients underwent a PSG after 1 year of SPT use (male/female ratio, 28/6; overall apnea/hypopnea index (AHI), 16/h). A significant reduction in overall AHI to 6/h was observed using treatment (p < 0.001). The median percentage of supine sleep decreased significantly to 1% with SPT (p < 0.001). The mean objective SPT use in 28 patients was 7.3 ± 0.9 h/night and 69 ± 26% of the nights. Furthermore, 75% of the patients reported a better sleep quality since the start of SPT treatment., Conclusions: Long-term treatment with the SPT was found to be effective in reducing overall AHI. Time spent sleeping in supine position was reduced to almost zero in the continuing users. Patient satisfaction was high when using the SPT.

Background: The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported., Methods: This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies., Discussion: Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods., Trial Registration: ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.

Study Objectives: Mandibular advancement device (MAD) outcome varies between patients. We hypothesized that upper airway collapse sites, patterns, and degrees assessed during baseline drug-induced sleep endoscopy (DISE) affect MAD outcome., Methods: One hundred patients with obstructive sleep apnea (OSA) were included and underwent baseline type 1 polysomnography. MAD was fitted intraorally at fixed 75% maximal protrusion. A total of 72 patients completed 3-month follow-up polysomnography and baseline DISE. Response was defined as apnea-hypopnea index (AHI) reduction ≥ 50%, deterioration as AHI increases during MAD treatment compared to baseline., Results: Adjusting for baseline AHI and body mass index, patients with tongue base collapse showed 3.69 higher odds (1.27-10.73; P = .0128) for response. Complete concentric collapse at the level of the palate (5.32 [1.21-23.28]; P = .0234) and complete laterolateral oropharyngeal collapse (6.62 [1.14-38.34]; P = .0330) related to deterioration. Results for tongue base collapse and complete concentric collapse at the level of the palate were confirmed in the moderate to severe OSA subgroup. Applying these results to this selected subgroup increased response rate with 54% and decreased deterioration rate with 53%. These results were confirmed using other response and deterioration definitions., Conclusions: Three baseline DISE phenotypes identified during drug-induced sleep were significantly related to MAD treatment outcome: one beneficial, tongue base collapse, and two adverse, complete concentric collapse at the level of the palate and complete laterolateral oropharyngeal collapse. If confirmed in future prospective studies, these results could guide patient selection for MAD outcome., Clinical Trial Registration: This prospective clinical trial (PROMAD) was registered on Clinicaltrials.gov with identifier: NCT01532050., Citation: Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic labelling using drug-induced sleep endoscopy improves patient selection for mandibular advancement device outcome: a prospective study. J Clin Sleep Med. 2019;15(8):1089-1099., (© 2019 American Academy of Sleep Medicine.)

Study Objectives: The objective of this study was to measure fatigue and hypersomnolence in patients with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD), using Epworth Sleepiness Scale (ESS) for hypersomnolence and Checklist Individual Strength questionnaire (CIS20R) for fatigue., Methods: This was a single-center, prospective cohort study. A total of 58 patients with OSA filled out ESS and CIS20R questionnaires at baseline and after 3 months of MAD treatment. A total of 39 full datasets were collected. Statistical analysis for reliability of the questionnaires, comparison between baseline and 3-month follow-up, correlation between the changes in the values of the two questionnaires, and changes in apnea-hypopnea index (AHI) were performed., Results: CIS20R showed excellent reliability in this patient group at baseline and 3-month follow-up (Cronbach α = .97), ESS showed a marginally good reliability (Cronbach α = .82). The CIS20R (82/140) expressed high levels of fatigue at baseline, and ESS showed a normal level of daytime sleepiness. AHI, ESS, and CIS20R were significantly reduced under MAD treatment. A significant correlation between ESS and CIS20R was observed. No significant correlation between any of the questionnaires and the change in AHI was found., Conclusions: The CIS20R questionnaire results showed a high level of fatigue in the patients with OSA, and the questionnaire can be used to evaluate changes in fatigue due to MAD treatment after 3 months. The ESS failed to show similar characteristics. Therefore, a combination of ESS for hypersomnolence with CIS20R for fatigue is proposed for the follow-up of patients with OSA treated with MAD., (© 2019 American Academy of Sleep Medicine.)

Study Objectives: The potential of a remotely controlled mandibular positioner (RCMP) during sleep studies in individual patients suffering from obstructive sleep apnea (OSA) for the determination of the effective target protrusive position (ETPP) of the mandible has been demonstrated. The research goal of this study was to assess the feasibility of the application of RCMP during drug-induced sleep endoscopy (DISE) for the determination of ETPP., Methods: Ten patients in whom OSA was diagnosed (50% male; age 54 ± 9.5 years; body mass index 26.9 ± 2.1 kg/m 2 ; apnea-hypopnea index 28.4 ± 13.2 events/h) were enrolled prospectively. Dental RCMP trays were fitted during wakefulness. Maximal protrusion and edge-to-edge positions were measured. Upper airway collapsibility was scored during DISE, including full-range mandibular RCMP titration within 45 minutes. ETPP was defined as the mandibular threshold protrusion yielding a stable upper airway in the absence of snoring, oxygen desaturation and apneas., Results: RCMP trays were retentive and no adverse reactions occurred. RCMP was fitted intraorally prior to sedation with maxillary and mandibular trays in edge-to-edge position. Upon sedation, progressive protrusion was performed followed by reversed titration until ETPP was noted. In one patient ETPP was not within the mandibular range of motion. In one patient RCMP needed to be removed because of clenching., Conclusions: The results of this study illustrate that it is feasible to use RCMP during DISE and to determine ETPP within 45 minutes. Comparative research with polysomnography would be useful to further validate the therapy outcome upon use of RCMP during DISE., (© 2018 American Academy of Sleep Medicine.)

Study Objectives: To assess the overall clinical effectiveness of a sleep position trainer (SPT) in patients with positional obstructive sleep apnea (POSA) and to evaluate how many patients were willing to continue treatment after a 1-month trial period., Methods: Patients in whom POSA was diagnosed underwent a 1-month trial period with the SPT. Home sleep apnea tests were used to measure baseline data and data following the trial period with the SPT., Results: The 79 patients who completed the study protocol were 81% male, had a mean age of 52 ± 12 years, and a median baseline respiratory event index (REI) of 11 (8, 16) events/h. A significant reduction in overall REI to 5 (3, 10) events/h was observed with the SPT as compared to baseline ( P < .001). The median percentage of sleep time in the supine position decreased significantly from 27 (20, 48) to 7 (2, 20) with the SPT ( P < .001). Adherence was found to be 95 ± 8%. Of the 44 patients who decided to continue treatment, 27 were categorized as responders (having a decrease in REI of at least 50%) and 17 were non-responders. The most important reasons for not purchasing the SPT were poor objective results, intolerance to the vibrations, cost of the device, persistent daytime sleepiness, or patient preference for other treatment options., Conclusions: Treatment with the SPT came with high adherence rates and was effective in reducing REI and supine sleep position. The trial period is in the patients' best interest, as it may prevent those who will not benefit from positional training from purchasing an SPT., (© 2018 American Academy of Sleep Medicine.)

Study Objectives: To perform a review of the current evidence regarding the use of a remotely controlled mandibular positioner (RCMP) and to analyze the efficacy of RCMP as a predictive selection tool in the treatment of obstructive sleep apnea (OSA) with oral appliances that protrude the mandible (OAm), exclusively relying on single-night RCMP titration., Methods: An extensive literature search is performed through PubMed.com, Thecochranelibrary.com (CENTRAL only), Embase.com, and recent conference meeting abstracts in the field., Results: A total of 254 OSA patients from four full-text articles and 5 conference meeting abstracts contribute data to the review. Criteria for successful RCMP test and success with OAm differed between studies. Study populations were not fully comparable due to range-difference in baseline apneahypopnea index (AHI). However, in all studies elimination of airway obstruction events during sleep by RCMP titration predicted OAm therapy success by the determination of the most effective target protrusive position (ETPP). A statistically significant association is found between mean AHI predicted outcome with RCMP and treatment outcome with OAm on polysomnographic or portable sleep monitoring evaluation (p < 0.05)., Conclusions: The existing evidence regarding the use of RCMP in patients with OSA indicates that it might be possible to protrude the mandible progressively during sleep under poly(somno)graphic observation by RCMP until respiratory events are eliminated without disturbing sleep or arousing the patient. ETPP as measured by the use of RCMP was significantly associated with success of OAm therapy in the reported studies. RCMP might be a promising instrument for predicting OAm treatment outcome and targeting the degree of mandibular advancement needed., (© 2016 American Academy of Sleep Medicine)

Obstructive sleep apnea syndrome (OSAS) is the most common sleep disordered breathing disorder (SDB) in adults and is characterized by a recurrent partial or complete collapse of the upper airway during sleep. This can be caused by many factors, sometimes interacting, such as skeletal malformations, soft tissue crowding, respiratory instability and the various effects of aging, obesity and gender that dictate craniofacial and upper airway anatomy. Research has demonstrated that the majority of patients exhibit at least one anatomical component such as retrognathia or a narrow posterior airway space that predisposes to the development of OSAS. Within the predisposing elements for OSAS many seem to point to anatomical characteristics. A standardized and relatively simple radiologic technique to evaluate anatomical craniofacial relationships is cephalometry. This has been used already for a long time in orthodontics, but is now gradually being introduced in OSAS treatment to envisage optimal treatment selection as well as to predict treatment outcomes. The purpose of the present review is to evaluate the contribution of cephalometry in the prediction of outcomes from OSAS treatments that depend on the upper airway morphology in their mechanisms of action such as oral appliances that advance the mandible as well as various surgical methods. In addition, an overview of imaging modalities and methods that currently are being used in cephalometric analysis in OSAS patients is provided. The findings indicate that isolated cephalometric parameters cannot be used to reliably predict treatment outcomes from mandibular advancement devices and surgical methods for OSAS. Extreme or outlying values of cephalometric parameters may rather be used as contra-indicators or 'red flags' instead of predictors., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Purpose: This prospective clinical trial assessed the therapeutic outcomes of patients with obstructive sleep apnea (OSA) treated with a novel duobloc custom-made titratable mandibular advancement device (OAm)., Material and Methods: The modular Somnomed G2® OAm (Somnomed Europe AG, Zurich, Switzerland) with 'click-to-fit' adjustability provides instant feedback on the mandibular advancement. 161 consecutive patients with established diagnoses of OSA. Dental impressions were made and a bite registration in 75% of the maximal protrusion being the starting protrusion. Treatment response was defined as ≥ 50% decrease in apnea-hypopnea index (AHI). Treatment success was defined as 1a) AHI with OAm < 5 events/h sleep or 1b) AHI with OAm < 10 events/h. Treatment success and response were combined to define additional criteria: 2a) reduction in AHI ≥ 50% and AHI < 5 events/h; and 2b) reduction in AHI ≥ 50% and AHI <10 events/h., Results: In 112 patients AHI decreased significantly from 25 ± 18/h sleep at baseline to 12 ± 13/h with the OAm (p < 0.001). The visual analogue scoring for snoring (VAS) decreased significantly from 7 ± 3 to 2 ± 2 (p < 0.001). Treatment response was achieved in 65 of 112 patients (58%); 31% and 57% of patients were treated successfully according to criteria 1a and 1b, respectively. Furthermore, 31% and 50% of patients were treated successfully according to criteria 2a and 2b, respectively., Conclusions: This clinical trial indicates that treatment with a novel custom-made OAm can reduce the severity of sleep-disordered breathing by significantly decreasing the AHI and VAS scores.

Importance: The main reported reasons for discontinuation of oral appliance therapy for sleep-disordered breathing (SDB) are the presence of self-perceived adverse effects and self-appreciated lack of efficacy. However, these conclusions rely only on subjective compliance data., Objective: To determine which parameters are correlated with objectively measured data on compliance with oral appliance therapy., Design, Setting, and Participants: For 51 outpatients with SDB, a prospective clinical trial using oral appliance therapy was conducted at Antwerp University Hospital from February 7, 2011, to October 8, 2013 (38 [75%] males; mean [SD] age, 49.3 [9.0] years; mean [SD] apnea-hypopnea index, 14.9 [9.3] events per hour of sleep; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 26.3 [2.8]). Analysis was performed November 5, 2014., Intervention: Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm)., Main Outcomes and Measures: Possible correlations were assessed between objective compliance and patients’ anthropometric characteristics, polysomnographic parameters, and answers to 3 subjective questionnaires (the visual analog scale for snoring, the Epworth Sleepiness Scale, and an adverse effects questionnaire)., Results: Median oral appliance use was 6.4 hours per night (range, 4.7-7.2 hours per night) at the 3-month follow-up. None of the anthropometric and polysomnographic parameters were correlated with compliance. No correlation was found between objective compliance and reports of excessive daytime sleepiness. However, a significant inverse correlation was found between objective compliance and posttreatment visual analog scale values for snoring (P = .006; ρ = –.40). In addition, objective compliance was correlated significantly with a more pronounced decrease in socially disturbing snoring (P = .005; ρ = 0.39). The presence of dry mouth was the only adverse effect that was negatively correlated with objective compliance at the 3-month follow-up (P < .05; ρ = –.31)., Conclusions and Relevance: Neither the anthropometric and polysomnographic parameters nor reports of excessive daytime sleepiness correlated with compliance during oral appliance therapy. The 2 parameters that were correlated with higher objective compliance during oral appliance therapy were a more pronounced decrease in snoring and the presence of dry mouth during treatment., Trial Registration: clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.

Purpose: The objective of this randomized controlled trial was to assess the additional effect of a chest-worn sleep position trainer (SPT) in patients with residual supine-dependent obstructive sleep apnea (sdOSA) under mandibular advancement device (MAD) therapy., Methods: Baseline and follow-up polysomnography with MAD were performed. Twenty patients with sdOSA under MAD therapy underwent two consecutive randomized polysomnographies: one with SPT and one with combination of SPT + MAD. Data are presented as median (quartile 1, quartile 3)., Results: The SPT reduced the time spent in supine sleeping position compared to baseline and MAD therapy. Both MAD and SPT were individually effective in reducing the overall apnea/hypopnea index (AHI) significantly when compared to baseline from 20.8 (15.1; 33.6)/h at baseline to 11.0 (6.7; 13.8)/h and to 11.1 (3.5; 17.7)/h with MAD or SPT, respectively. The combination of SPT + MAD further reduced the overall AHI to 5.7 (3.6; 7.4), which was significantly lower than with MAD alone (p < 0.001) and SPT alone (p < 0.008), respectively., Conclusions: The results of this study indicate that combination of SPT + MAD leads to a higher therapeutic efficacy in patients with sdOSA under MAD therapy when compared to one of the treatment modalities alone.

Study Objective: The prevalence of supine-dependent obstructive sleep apnea (sdOSA) in a general population ranges from 20% to 60%, depending on the criteria used. Currently, the prevalence and evolution of sdOSA once oral appliance therapy with a mandibular advancement device (OAm) has started is unknown. In addition, literature on the correlation between sdOSA and treatment success with OAm is not unequivocal. The first purpose of this study was to assess the prevalence of sdOSA before and under OAm therapy. Second, the conversion rate from non-sdOSA to sdOSA during OAm therapy was evaluated. The third and final goal was to analyze the correlation between sdOSA and treatment success with OAm therapy in the patient population., Methods: Two hundred thirty-seven consecutive patients (age 48 ± 9 years; male/female ratio 173/64; AHI 20.1 ± 14.7 events/h; BMI 27.2 ± 4.3 kg/m(2)) starting OAm therapy were included., Results: The prevalence of sdOSA before the start of OAm therapy, ranged from 27.0% to 67.5%. The prevalence of residual sdOSA under OAm therapy in this study ranged from 17.5% to 33.9%. Second, the conversion rate from non-sdOSA to sdOSA ranged from 23.0% to 37.5%. Third, the presence of sdOSA at baseline was not a significant factor for treatment success with OAm therapy., Conclusions: The results of this study indicate that the prevalence of sdOSA before and under OAm therapy is relatively high. One-third of patients shift from non-sdOSA to sdOSA. Finally, treatment success for OAm therapy was not significantly correlated with the presence of sdOSA at baseline., (© 2014 American Academy of Sleep Medicine.)

Background: When a surgeon uses a percutaneous volar approach to treat scaphoid waist fractures, central screw placement is complicated by the shape of the scaphoid and by obstruction by the trapezium. In this study, we used radiographs and biomechanical tests to compare the standard volar percutaneous approach with the transtrapezial approach, with regard to central screw placement at the distal pole of the scaphoid., Methods: Fourteen matched pairs of cadaveric wrists were randomly assigned to two treatment groups. Under fluoroscopic control, a guidewire was drilled into the scaphoid, either through a transtrapezial approach or through a standard volar approach that avoided the trapezium. Guidewire position was measured in the coronal and sagittal planes. A transverse osteotomy was performed along the scaphoid waist, and this was followed by the insertion of the longest possible cannulated headless bone screw. Each specimen was placed into a fixture with a pneumatically driven plunger resting on the surface of the distal pole. Load was applied by using a load-controlled test protocol in a hydraulic testing machine., Results: All guidewires were inside the central one-third of the proximal pole. The guidewire positions at the distal pole differed significantly between the transtrapezial and standard volar approach groups (p < 0.001). The load to 2 mm of displacement and the load to failure averaged, respectively, 324.4 N (standard error of the mean [SEM] = 73.5 N) and 386.4 N (SEM = 65.6 N) for the transtrapezial approach group compared with 125.7 N (SEM = 22.6 N) (p = 0.002) and 191.4 N (SEM = 36.30 N) (p = 0.005) for the standard volar approach group., Conclusions: The data suggest that, in a cadaveric osteotomy-simulated scaphoid waist fracture model, the transtrapezial approach reliably achieves central positioning of a screw in the proximal and distal poles. This position offers a biomechanical advantage compared with central placement in only the proximal pole., (Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.)

Purpose: Clinical pathways are used to organize complex care processes by providing structure and standardization. The multidisciplinary approach of oral appliance (OA) therapy for sleep-disordered breathing (SDB) is a complex and dynamic process suitable for such a structured pathway approach., Methods: A clinical pathway for patients referred for OA therapy was developed and implemented. The aim of this study was to evaluate the impact of this clinical pathway on the time to delivery of the OA and the organization of the multidisciplinary dental sleep clinic (MDSC). The latter was achieved using the care process self-evaluation tool (CPSET)., Results: First, development and implementation of the clinical pathway gave structure and shortened the mean time to delivery by 102 days (240 ± 70 vs. 138 ± 33 days) (Mann-Whitney U: P < 0.001). Second, the CPSET scores were obtained in a cohort of 49 healthcare professionals involved in the pathway. Overall, patient-focused organization received the highest scores (80.5 ± 9.0%), whereas cooperation with primary care received the lowest score (66.7 ± 12.4%)., Conclusions: This is the first project on clinical pathways in OA therapy for SDB. The implementation of the pathway in our MDSC has created a significant shortening of the time to delivery. A first evaluation of the clinical pathway using the CPSET scores indicates that all disciplines involved should be thoroughly informed in an ongoing approach.

Purpose: In order for a mandibular advancement device (MAD) to be efficacious, it must remain seated on the teeth during sleep. Quantitative data on the retentive characteristics of MADs are currently unavailable. The present pilot study is the first to describe an in vitro setup testing the retentive characteristics of different monobloc MADs., Methods: A hydraulic cyclic test machine was used with MADs seated on dental casts to measure retention forces upon removal of the MADs. A custom-made monobloc (CM-mono), a thermoplastic monobloc (TP-mono), and a thermoplastic duobloc (TP-duo) configured as a monobloc were tested. Two protrusions were investigated, representing 25 and 65% of the maximal protrusion. The effects of the type of MAD, duration of the test, and amount of protrusion on removal forces were measured., Results: The measured removal forces of all three MADs tested differed significantly, with the TP-duo showing the highest values (P < 0.0001). The effects of wear due to the repetitive cyclic loading became obvious by the production of wear particles in all MADs tested. However, only the TP-duo showed a significant reduction in time in removal forces for both protrusion positions (P < 0.0001; P = 0.0011). The effect of the amount of protrusion on the removal forces differed significantly between all three MADs tested (P = 0.0074)., Conclusions: This in vitro pilot study reveals significant differences in retention forces for the MADs tested. The findings are consistent with clinical effects of nightly loss of MADs as reported in the literature and are within the range of reported physiological mouth-opening forces. Future research is needed to determine the key design features of MADs that explain these differences.

Objectives/hypothesis: To describe upper airway (UA) collapse patterns during drug-induced sleep endoscopy (DISE) in a large cohort of patients with sleep-disordered breathing (SDB) and to assess associations with anthropometric and polysomnographic parameters., Study Design: Observational study., Methods: A total of 1,249 patients [age 47 ± 10 y; apnea-hypopnea index (AHI) 18.9 ± 15.3/h; body mass index (BMI) 27.2 ± 3.7 kg/m(2)] underwent polysomnography and DISE. DISE findings were categorized to the following UA levels: palate, oropharynx, tongue base, and hypopharynx. The degree of collapse was reported as complete, partial, or none. The pattern of the obstruction was described as anteroposterior, lateral, or concentric. Associations between DISE findings and anthropometric and polysomnographic parameters were analyzed., Results: Palatal collapse was seen most frequently (81%). Multilevel collapse was noted in 68.2% of all patients. The most frequently observed multilevel collapse pattern was a combination of palatal and tongue base collapse (25.5%). Palatal collapse was seen most frequently (81%). The prevalence of complete collapse, multilevel collapse, and hypopharyngeal collapse increased with increasing severity of obstructive sleep apnea (OSA). Multilevel and complete collapse were more prevalent in obese patients and in those with more severe OSA. Both higher BMI and AHI values were associated with a higher probability of complete concentric palatal collapse., Conclusion: The current study provides an overview of UA collapse patterns in a large cohort of SDB patients who underwent DISE. The associations found in this study may indicate that UA collapse patterns observed during DISE cannot be fully explained by selected baseline polysomnographic and anthropometric characteristics., (© 2013 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: Oral appliance therapy with a mandibular advancement device (OAm) can yield to complete therapeutic response (apnea-hypopnea index [AHI]<5 events/h), though some patients show little or no improvement in daytime sleepiness. The prevalence of residual excessive sleepiness (RES) despite effective treatment with OAm therapy is unknown. We aimed to determine the prevalence of RES in patients treated with a titratable custom-made duobloc OAm., Methods: A prevalence study was performed, collecting data from 185 patients with an established diagnosis of sleep-disordered breathing (SDB) under OAm therapy with a titratable custom-made duobloc device (baseline data were male:female ratio, 129:56; age, 48±9 years; body mass index [BMI], 27±4 kg/m2; Epworth Sleepiness Scale [ESS] score, 10±5; and AHI, 19±12 events/h). A full-night polysomnography was performed at baseline and after 3 months of OAm therapy. Daytime sleepiness was assessed using the ESS with RES defined as an ESS score of 11 or higher out of 24, despite complete therapeutic response., Results: Out of 185 patients, 84 patients (45%) showed a complete therapeutic response with an AHI of <5 events per hour after 3 months of OAm therapy. Despite this normalization of AHI, 27 out of these 84 patients (32%) showed RES and had a significantly higher baseline ESS (15±4 vs. 9±4; P<.001) and were younger (43±9 vs. 47±9; P=.028) compared to patients without RES., Conclusion: RES under OAm therapy showed a prevalence of up to 32% in SDB patients effectively treated with respect to AHI. Patients with RES were younger and had higher baseline daytime sleepiness., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Background: Assessment of the overall therapeutic effectiveness of oral appliance therapy can only be realized through objectively measured compliance. The aims of this study were to assess objectively measured compliance during oral appliance therapy at 1-year follow-up and to compare these data with self-reported use., Methods: Fifty-one eligible patients were enrolled in this 1-year prospective clinical study (men, 61%; mean age, 49 ± 10 years; apnea-hypopnea index, 18.0 ± 11.9 events/h sleep; BMI, 26.6 ± 4.1 kg/m²). Objective compliance during oral appliance therapy at 1-year follow-up was assessed with a microsensor thermometer. Subjective compliance was assessed by self-report. Patients with a mean objectively measured use of ≥ 4 h/night on 70% of nights monitored were considered regular users. The mean disease alleviation was calculated as a measure of overall therapeutic effectiveness., Results: High agreement between objective and subjective compliance data at 1-year follow-up was reported (intraclass correlation coefficient, 0.8; 95% CI, 0.5-0.9), showing a mean subjective overestimation of 30 min (95% CI, -3.1 to 1.9; P = .02). The discontinuation rate at 1-year follow-up was 9.8%. The objective mean use rate was 6.4 ± 1.7 h/night at 1-year follow-up in continuing users, with a regular use rate of 83%. The mean disease alleviation was 54.9%., Conclusions: This study is the first to our knowledge to report the 1-year results of objectively measured compliance during oral appliance therapy. In addition, a high agreement between objective and subjective compliance data were reported, with a mean subjective overestimation of 30 min., Trial Registry: ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.

Purpose: Type D personality, defined as a combination of social inhibition and negative affectivity, has been associated with poor medication adherence and lower adherence to continuous positive airway pressure in patients with sleep-disordered breathing. Up to this date, the association of patient's personality with adherence with a mandibular advancement device (MAD) has not been studied. The purposes of this study were to examine the association between type D personality and poor adherence to MAD treatment and to examine the impact of type D personality on perceived side effects during this treatment., Methods: Eighty-two patients out of 113 patients with a known baseline type D scale who have started MAD treatment between June 2006 and December 2009 were included. Information about side effects and adherence were collected via a postal questionnaire. Thirty-three patients were using a monobloc MAD and 49 patients were using a duobloc MAD., Results: Forty-five percent of type D patients discontinued MAD treatment, whereas only 15 % of non-type D patients reported treatment discontinuation. The odds ratio for treatment discontinuation was 6.03 (95 % confidence interval 1.22-29.81; p = 0.027) for type D personality, adjusted for age, gender, MAD type (monobloc or duobloc), and decrease in apnea severity. In continuing MAD users, no significant difference in perceived side effects was reported between the personality types., Conclusion: This is the first study to examine the relationship between type D personality and adherence to MAD treatment. Type D patients reported a significantly higher discontinuation rate when compared to patients without type D personality.

The aim of this study was to assess the value of drug-induced sleep endoscopy (DISE) using a custom-made simulation bite in maximal comfortable protrusion (MCP) of the mandible, in the prediction of treatment outcome for obstructive sleep apnea (OSA) with a mandibular advancement device (MAD). Two hundred patients (74% male; age 46 ± 9 years; apnea-hypopnea index [AHI] 19 ± 13 h(-1) sleep; body mass index [BMI] 27 ± 4 kg m(-2) ) with sleep-disordered breathing underwent DISE with a simulation bite in MCP. One hundred and thirty-five patients with an established diagnosis of OSA commenced MAD treatment. The associations between the findings during DISE with simulation bite and treatment outcome were evaluated. Treatment response was defined as a reduction in AHI following MAD treatment of ≥ 50% compared to baseline. Overall MAD treatment response in the studied population was 69%. The results of this study demonstrated a statistically significant association between a positive effect of the simulation bite on the upper airway patency during DISE and treatment response with MAD (P < 0.01). The results of this study suggest that the use of a simulation bite in maximal comfortable protrusion (MCP) of the mandible, as used during DISE in patients with OSA, tends to be effective in predicting treatment response of MAD treatment., (© 2012 European Sleep Research Society.)

Study Objective: To determine variations in interobserver and intraobserver agreement of drug-induced sleep endoscopy (DISE) in a cohort of experienced versus nonexperienced ear, nose, and throat (ENT) surgeons., Design: Prospective, blinded agreement study., Setting: Ninety-seven ENT surgeons (90 nonexperienced with DISE; seven experienced) observed six different DISE videos and were asked to score the upper airway (UA) level (palate, oropharynx, tongue base, hypopharynx, epiglottis), direction (anteroposterior, concentric, lateral), and degree of collapse (none; partial or complete collapse). Findings were collected and analyzed, determining interobserver and intraobserver agreement [overall agreement (OA), specific agreement (SA)] and kappa values per UA level., Measurement and Results: In the nonexperienced group, overall interobserver agreement on presence of tongue base collapse (OA = 0.63; kappa = 0.33) was followed by the agreement on epiglottis (OA = 0.57; kappa = 0.23) and oropharynx collapse (OA = 0.45; kappa = 0.09). Low overall interobserver agreement in this group was found for hypopharyngeal collapse (OA = 0.33; kappa = 0.08). A similar ranking was found for degree of collapse. For direction of collapse, high interobserver agreement was found for the palate (OA = 0.57; kappa = 0.16). Among the experienced observers, overall interobserver agreement was highest for presence of tongue base collapse (OA = 0.93; kappa = 0.71), followed by collapse of the palate (OA = 0.80; kappa = 0.51). In this group, lowest agreement was also found for hypopharyngeal collapse (OA = 0.47; kappa = 0.03). Interob-server agreement on direction of collapse was highest for epiglottis collapse (OA = 0.97; kappa = 0.97). Concerning the degree of collapse, highest agreement was found for degree of oropharyngeal collapse (OA = 0.82; kappa = 0.66). Among the experienced observers a statistically significant higher interobserver agreement was obtained for presence, direction, and degree of oropharyngeal collapse, as well as for presence of tongue base collapse and degree of epiglottis collapse. Among the nonexperienced observers, high intraobserver agreement was found in particular for tongue base and epiglottis collapse. Among the experienced observers, high agreement was found for all levels but to a lesser extent for hypopharyngeal collapse. Intraobserver agreement was statistically significantly higher in the experienced group, for all UA levels expect for the hypopharynx., Conclusion: This study indicates that both interobserver and intraobserver agreement was higher in experienced versus nonexperienced ENT surgeons. Agreement ranged from poor to excellent in both groups. The current results suggest that experience in performing DISE is necessary to obtain reliable observations.

Purpose: This prospective clinical study investigates the efficacy of a specific custom-made titratable mandibular advancement device (MAD) for the treatment of obstructive sleep apnea (OSA). This MAD has attachments in the frontal teeth area that allow for progressive titration of the mandible., Methods: Sixty-one adult OSA patients were included (age, 46.7 ± 9.0 years; male/female ratio, 45/16; apnea-hypopnea index (AHI), 23.2 ± 15.4 events/h sleep; body mass index, 27.9 ± 4.1 kg/m²). After an adaptation period, titration started based on a protocol of symptomatic benefit or upon reaching the physiological limits of protrusion. As a primary outcome, treatment response was defined as an objective reduction in AHI following MAD treatment of ≥50 % compared to baseline, and treatment success as a reduction in AHI with MAD to less than 5 and 10 events/h sleep. Compliance failure was defined as an inability to continue treatment., Results: A statistically significant decrease was observed in AHI, from 23.4 ± 15.7 at baseline to 8.9 ± 8.6 events/h with MAD (p < 0.01). Treatment response was achieved in 42 out of 61 patients (68.8 %), whereas 42.6 % met criteria of AHI < 5 and 63.9 % achieved an AHI < 10 events/h sleep, respectively. Four patients (6.6 %) were considered as "compliance failures.", Conclusions: The present study has evaluated the efficacy of a specific custom-made titratable MAD in terms of sleep apnea reduction.

Background: Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report., Methods: In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0 ± 11.9/h; age 47 ± 10 y; BMI 26.6 ± 4.0 kg/m(2); men/women: 31/20). Patients were unaware of the purpose of the study., Results: No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6 ± 1.3 h per day with a regular OA users' rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%., Conclusions: The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.

Obstructive sleep apnea is characterized by recurrent obstruction of the upper airway during sleep, resulting in episodic reductions in blood oxygen saturation and arousals from sleep. Mandibular repositioning appliances (MRAs) which are worn intra-orally at night, mechanically advance the mandible to help maintain a patent oropharygeal airway and have been proven to be an effective alternative for continuous positive airway pressure in the treatment of obstructive sleep apnea. Titratable MRAs are designed to gradually protrude the mandible applying an easy-to-use mechanical advancing mechanism, until a protrusive position with positive effect on sleep apnea is reached. Considering the relatively low-tech approach of the basic advancement mechanism, the interest in the mechanistic element of the dental treatment of obstructive sleep apnea has increased. The present paper provides an overview of the different titration protocols described in the recent literature together with a discussion of both the clinical and mechanical aspects of treatment. At present, a consensus exists that an optimal titration protocol is of primary importance to achieve a successful treatment outcome with an MRA. To date however, there is no consensus on how to define the optimal titration protocol., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: It is still subject to controversy if an increased vertical opening (VO) is beneficial in oral appliance therapy for the treatment of obstructive sleep apnoea. Each oral appliance has a given thickness causing VO. Therefore, evaluation of the effects of the amount of VO on pharyngeal dimensions is mandatory., Methods: The effects of VO on the cross-sectional area of the upper airway at the level of the tongue base during sleep endoscopy were scored and categorised., Results: The figures demonstrate the possible effects of VO on pharyngeal collapse relative to the baseline cross-sectional area and the maximal comfortable protrusion of the mandible. Thirty-two patients (80%) showed an adverse effect of VO (Fig. 1), one patient (2.5%) had a positive effect (Fig. 2), and seven patients (17.5%) demonstrated an indifferent effect (Fig. 3)., Conclusion: Based on literature, the effect of VO on pharyngeal collapse is unclear and the therapeutic impact of VO is not determined. The results of the present study indicate that the effect of VO on the degree of pharyngeal collapse as assessed during sleep endoscopy tends to be adverse, causing an increase in collapsibility in the majority of patients., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Rationale: The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices., Objectives: Our purpose was to compare the efficacy of both types of devices in patients with SDB., Methods: A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval., Measurements and Main Results: A total of 35 patients (29 males; age, 49 +/- 9 yr; apnea-hypopnea index [AHI], 13 +/- 11 events/h; body mass index, 28 +/- 4 kg/m(2)) completed the protocol. AHI was only reduced with the custom-made device (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001)., Conclusions: In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.

Mandibular advancement devices (MADs) have emerged as a popular alternative for the treatment of sleep-disordered breathing. These devices bring the mandibula forward in order to increase upper airway (UA) volume and prevent total UA collapse during sleep. However, the precise mechanism of action appears to be quite complex and is not yet completely understood; this might explain interindividual variation in treatment success. We examined whether an UA model, that combines imaging techniques and computational fluid dynamics (CFD), allows for a prediction of the treatment outcome with MADs. Ten patients that were treated with a custom-made mandibular advancement device (MAD), underwent split-night polysomnography. The morning after the sleep study, a low radiation dose CT scan was scheduled with and without the MAD. The CT examinations allowed for a comparison between the change in UA volume and the anatomical characteristics through the conversion to three-dimensional computer models. Furthermore, the change in UA resistance could be calculated through flow simulations with CFD. Boundary conditions for the model such as mass flow rate and pressure distributions were obtained during the split-night polysomnography. Therefore, the flow modeling was based on a patient specific geometry and patient specific boundary conditions. The results indicated that a decrease in UA resistance and an increase in UA volume correlate with both a clinical and an objective improvement. The results of this pilot study suggest that the outcome of MAD treatment can be predicted using the described UA model.

The aim of this study was to investigate the flexural fatigue behavior of 11 packable composites. Of each material 30 rectangular samples (1.2 x 5 x 35 mm) for flexural fatigue test were prepared. The clamped fracture strength and flexural fatigue limit (FFL) of each material were determined using a custom-made fatigue machine, after storage of the samples for one month in water at 37 degrees C. All data were analyzed using one-way ANOVA and Bonferroni/Dunn's test for multiple comparisons (p<0.05). Regression analysis was used to evaluate the relationship between elastic modulus (Abe et al., 2001), clamped fracture strength or FFL and inorganic filler fraction (vol%). The fracture strengths of all but two materials were in between those of the compact-filled densified composites and the microfine ones. The FFL of the packable composites tested were significantly lower than those of the compact-filled densified composites. Three of the tested materials showed even significantly lower FFL than did the microfine composites. There were statistically significant relationships between both the elastic modulus and the volumetric filler fraction (R(2)=0.974, p=1.990 x 10(-7)). The great diversity in packable composites makes clinical assessment necessary with regard to a justified use in posterior teeth.

Objective: Mandibular advancement devices (MADs) have been introduced as a conservative, non-invasive treatment for socially disturbing snoring and mild obstructive sleep apnea (OSA). A prospective, non-randomized pilot study was conducted to investigate the efficacy, feasibility, side-effects and compliance of Somnoguard, an immediately intraorally adaptable MAD made from thermoplastic material., Material and Methods: Twenty consecutive heavy snorers with a respiratory disturbance index of <20 events/h were prospectively selected. Prior to the adaptation of the appliance, ambulatory polygraphy was carried out without a MAD. After a 1-month habituation period, a polygraphic evaluation was carried out with the device. Treatment success was defined as a reduction in the apnea-hypopnea index (AHI) of at least 50%., Results: The results indicated a success rate of 65%. The AHI decreased from 8.4 +/- 2.9 events/h at baseline to 3.9 +/- 1.8 events/h with the device (p = 0.001). At 1-month follow-up, significant reductions in the snoring index (p < 0.001) and the Epworth Sleepiness Scale (ESS) score (p = 0.036) were noted. At 6-month follow-up, similar results were achieved, with significant drops in the snoring index (p = 0.025) and ESS score (p = 0.033)., Conclusion: We conclude that immediate intraoral adaptation of a low-cost fabricated "one-size-only" MAD is a feasible and well-tolerated treatment for snoring and mild OSA. Further research is needed to evaluate this thermoplastic appliance as a strategy to "screen" the efficacy of MAD treatment in the individual patient with a less expensive appliance before constructing a more expensive custom-made MAD.

Objective: A new type of so-called 'packable', 'condensable' or 'mouldable' composite has been developed and aims at replacing amalgam for posterior restorations. The purpose of the present investigation was to study the dynamic elastic modulus of 12 packable composites, and to follow the evolution of this property following prolonged water absorption., Methods: Of each material ten rectangular samples (1.5x5x35 mm) were prepared. The elastic modulus (GPa) of each sample was determined with a non-destructive dynamic method using a Grindo-Sonic after 24 h of dry storage at room temperature, and after 24h, 1, 3 and 6 months of wet storage at 37 degrees C. All data were analyzed using two-way ANOVA, Bonferroni/Dunn's test for multiple comparisons and paired t-test with a significance level of p<0.05. In addition, inorganic filler volume percentages were derived from the phenomenological model introduced by Braem et al. [11]., Results: The studied materials varied widely in terms of elastic modulus, ranging between composites classified as Compact-Filled Densified (elastic modulus of 23.4+/-2.4 GPa) and as Microfine (elastic modulus of 8.5+/-2.1 GPa)., Significance: The great diversity observed in the elastic modulus of this type of composites necessitates clear specifications with regard to 'first' the definition of marketing terms such as packable and so on, and 'second' the justified use in posterior teeth.

The expression of damage in dental composite restoratives varies widely, going from some local damage as in attrition facets, to generalized failure or collapes of a restoration. However, crack growth lies on the basis of both aforementioned phenomena. It is therefore of primary importance to gain insight in the way structurally differing materials respond to external stress. It is the aim of the present review to summarize some recent in vitro studies that deal with simulation of wear and fatigue phenomena in dental composite restorative materials.

Objectives: This in vitro study was conducted to investigate the fatigue behavior of several dental restoratives, including composites, glass ionomers and a resin-reinforced glass ionomer., Methods: Fatigue was imposed under a reverse stress-controlled regimen, following a staircase approach. Samples were stored and tested under both dry and wet conditions. The following parameters were measured and analyzed: Young's modulus, restrained fracture strength, and flexural fatigue limit., Results: As a general trend, all products showed a decrease in Young's modulus following water sorption. For all products except the resin-reinforced glass ionomer, the same trend was seen in the restrained fracture strength. This is, however, no longer valid for the flexural fatigue limit: the trend is steady-state for the glass ionomers, status quo for the resin-reinforced glass ionomer, and all composites tested show a decrease., Significance: The diversity in structure of both composites and glass ionomers does not allow findings for one product to be extrapolated to other similar products.

The flexural fatigue test equipment developed was used to study the fatigue behavior of dental restorative composites, using a "staircase" approach. Three commercial composites were tested after dry and wet storage conditions. The findings indicate that the method is accurate and reliable, and that changes due to water sorption are clearly reflected: The flexural fatigue limit decreases after water sorption. From the present results it seems that under environmentally controlled conditions, the fatigue behavior is characterized by a well-defined fatigue stress level above which the composites tested fail rapidly, and below which they survive.

Used and almost emptied syringes of two brands of composites contained material close to the pestle-head that appeared to be more granular and dry, as compared to the composite obtained from unused syringes. The present results suggest that a derangement of filler and matrix phases occurred inside the used syringes when compared to unused controls. Stress imposed on the composite material inside the unused syringes resulted in a comparable derangement of filler and matrix phases. Although this derangement was limited, the effect could contribute to intra- and interlaboratory scattering of data.