Background and Objective A key unresolved mechanistic question in obstructive sleep apnea (OSA) therapy with mandibular advancement devices (MAD) is how incremental advancement affects position-specific disease burden.This study aimed to evaluate the dynamic changes in apnea-hypopnea index (AHI) in different body positions in response to stepwise mandibular advancements, using the mandibular jaw movement (MJM)-based monitoring technology. Methods A prospective cohort study was conducted in OSA patients eligible for MAD therapy with a standardized titration protocol. Home sleep tests with MJM analysis were performed at baseline, and three successive advancement levels (initial, intermediate, and maximal). Regression analysis with adjustments for time-varying confounding factors was applied to estimate the adjusted changes in residual AHI in supine and non-supine positions. Results Ninety-six patients completed titration and follow-up. MAD titration did not significantly modify supine sleep time. Relative to baseline, early and significant improvements were observed for both supine and non-supine AHI at the initial advancement level (relative reduction of -60.1% [95% CI: -67.9; -52.2] and -55.0% [95% CI: -61.1; -48.9], respectively). Thereafter, AHI responses diverged: supine AHI continued a progressive reduction through to end of titration (mean cumulative change: -78.4% [95% CI: -82.7; -74.2]), whereas non-supine AHI showed little additional change beyond the initial improvement (mean cumulative change: -63.3% [95% CI: -68.2; -58.3]). Positional OSA prevalence was reduced from 38.5% at baseline to 18.3% at endpoint. Conclusions These findings underscore the value of continuous, home-based monitoring of position-specific residual AHI during MAD titration, and support integrating MJM analysis into MAD therapy workflows.
Objectif Évaluer l’association entre la durée cumulée de sommeil passé en effort respiratoire augmenté (REMOV), mesurée par le monitoring des mouvements mandibulaires (MJM), et les plaintes cliniques rapportées par les patients atteints de SAOS. Méthodes Étude transversale incluant 1000 adultes consécutifs adressés pour suspicion de SAOS. Le bilan comprenait une polysomnographie en laboratoire associée à une analyse automatisée des mouvements mandibulaires (Sunrise, Belgique), et l’évaluation des symptômes cliniques à l’aide de questionnaires validés : somnolence diurne (Epworth Sleepiness Scale, ESS), fatigue et symptômes dépressifs (questionnaire de Pichot). Le paramètre principal, REMOV, était défini comme le pourcentage du temps total de sommeil ( % TTS) marqué par un effort respiratoire accru associé à des événements obstructifs (apnées, hypopnées ou micro-éveils liés à l’effort respiratoire [RERAs]). Résultats L’échantillon de 1000 participants (51,7 % d’hommes) présentait la distribution suivante de sévérité du SAOS : non-SAOS 9,3 %, forme légère 26,8 %, modérée 28,8 % et sévère 35,1 % (Fig. 1). La charge symptomatique était élevée, avec 62,7 % des participants rapportant une somnolence diurne excessive (ESS≥10), 48,1 % une fatigue modérée à sévère (Pichot FSS : 16–32) et 33,3 % un dépistage positif de symptômes dépressifs (Pichot QD2≥7). Les médianes de REMOV augmentaient parallèlement à la sévérité du SAOS, atteignant 6,5 %, 23,4 %, 28,8 % et 42,8 % pour des index d’apnées-hypopnées (IAH) <5, 5–15, 15–<30 et ≥30 événements/h, respectivement. L’analyse en composantes principales (Fig. 1) a montré que REMOV représentait une dimension informationnelle distincte des métriques polysomnographiques classiques. Par ailleurs, REMOV était fortement associé à la somnolence diurne excessive, à la fatigue et aux symptômes dépressifs, en particulier chez les patients présentant un IAH≤15 événements/h. A l’inverse, l’IAH n’était pas corrélé à ces symptômes. Conclusion REMOV apparaît comme un nouveau biomarqueur digital pertinent du SAOS, en particulier dans ses formes légères à modérées. Pris en compte aux côtés de l’IAH, qui demeure la base de la classification de la sévérité du SAOS, il peut améliorer la concordance entre symptômes rapportés et décisions thérapeutiques, et ainsi affiner la personnalisation de la prise en charge.
Background Benralizumab is an anti-IL-5Rα antibody used as add-on maintenance therapy in patients with severe eosinophilic asthma (SEA). Materials and Methods The prospective, observational BE-REAL study evaluated the outcomes in SEA patients treated with benralizumab in a Belgian real-world setting. The primary objective of the study was to assess within-patient improvement of a minimum clinically important difference (MCID) in Asthma Control Questionnaire-6 (ACQ-6) (i.e., ≥ 0.5 units) up to 6 months (or 24 weeks). Secondary objectives include the change in ACQ-6 at weeks 56 and 112, the change in the daily oral corticosteroid (OCS) use, changes in asthma status and disease severity, healthcare resource utilization, treatment satisfaction, exacerbation rate and safety. Clinical remission rate was determined by combining the effect on asthma control, OCS use and exacerbation rate. Results 78 patients were screened, 2 were screening failures and 76 received at least one dose of benralizumab. At week 24, 71% of patients achieves an ACQ-6 response. Reductions in ACQ-6 scores were seen within 1 week of therapy. Over 112 weeks, the mean ACQ-6 score was reduced by 1.60 points (>3-fold MCID), the Annualized Exacerbation Rate (AER) was reduced by 82%, and the mean daily dose of OCS was reduced by 90%. 44% of patients in BE-REAL fulfilled the definition of clinical remission at week 56. Benralizumab was well-tolerated and associated with an improved perception of disease severity and a reduced healthcare utilization. Conclusion BE-REAL provide a real-world confirmation of the clinical trial data obtained with benralizumab showing both favourable short and long-term outcomes.
INTRODUCTION:Oral appliance therapy (OAT) for obstructive sleep apnea (OSA) is a complex and dynamic intervention that requires efficient tools to evaluate treatment response and monitor therapeutic outcomes. AREA COVERED:This review aims to provide a structured overview of current techniques for OAT monitoring, with a particular focus on mandibular jaw movement (MJM) analysis - a promising yet underutilized approach. Literature searches were conducted in PubMed, Scopus, and the Cochrane Library databases up to February 2025. Fifty-six studies were examined, encompassing morphometric and physiological measurements applied at different stages of OAT management in OSA patients. A wide range of measurement techniques were identified and categorized into three groups based on clinical utility. EXPERT OPINION:The clinical relevance of any monitoring technique depends on its dynamic or static properties, the clinical setting (in sleep or wakefulness) and alignment with the specific clinical objectives within the OAT workflow. While static imaging and endoscopic-based methods offer anatomical and functional insights, only sleep-based assessments can capture treatment efficacy in clinically meaningful terms. Among alternative technologies for sleep testing, MJM analysis stands out as a promising approach for continuous and reliable monitoring, with ability to evaluate the dynamic, synchronized mechanisms underlying OAT efficacy.
The clinical symptoms of obstructive sleep apnea (OSA) are poorly correlated with disease severity based on the apnea-hypopnea index (AHI). The cumulative duration of respiratory effort assessed by mandibular jaw movement monitoring with automated analysis (REMOV) may better capture the clinical burden of OSA. This cross-sectional study assessed the association between REMOV and patient-reported outcomes (PROs), including sleepiness, fatigue, and depression. One thousand adults referred for suspected OSA underwent polysomnography, REMOV analysis, and PRO assessment using validated questionnaires. Relationships between REMOV, AHI, and PROs were examined using principal component analysis and regression models. Median REMOV values align with OSA severity (6.5
RATIONALE:Unintentional air leaks are common during continuous positive airway pressure (CPAP) therapy and represent a leading cause of treatment failure. OBJECTIVE:To investigate the temporal association between respiratory effort (RE)-driven mouth opening and the occurrence of mouth leaks in patients with obstructive sleep apnea (OSA) during CPAP therapy. METHODS:Polysomnography with simultaneous mandibular jaw movements (MJM) and leak-flow monitoring was conducted in 200 OSA patients during CPAP therapy. The main analysis included 1,494 data fragments (mean duration: 9.34 ± 6.33 min) classified as leak-free controls, sequential intermittent leaks (Group A), and isolated sustained leaks (Group B). Multistep analyses included regression modeling and bidirectional Granger-causality testing. MEASUREMENTS AND MAIN RESULTS:Compared with leak-free control fragments, leak periods were significantly associated with higher levels of RE and mouth opening amplitudes. Regression analyses showed that mouth leaks were associated with increased sleep fragmentation, significant reduction in N3 sleep stage proportion (-5.34%) and more residual obstructive events during CPAP. Each 1-standard deviation increase in the number of leak episodes was associated with a 38% increase in arousal index and a 34% increase in residual obstructive apnea/hypopnea event rate. Bidirectional Granger-causality tests indicated that mouth opening was preceded by increased RE and subsequently induced leaks in most cases (Group A, 93.6%; Group B, 91.5%). CONCLUSION:Mouth opening driven by persistent RE is a measurable mechanism contributing to the overall burden of mouth leaks during CPAP therapy in OSA. Integrating MJM recordings with leak monitoring may help identify leak origin, guide targeted interventions, and ultimately improve CPAP effectiveness and adherence.
Objectif Évaluer dans quelle mesure l’ouverture buccale déclenchée par l’effort respiratoire contribue à la survenue de fuites d’air non intentionnelles chez les patients atteints de syndrome d’apnées obstructives du sommeil (SAOS) traités par pression positive continue (PPC). Méthodes Une polysomnographie avec enregistrement simultané des mouvements mandibulaires (MJM) (Sunrise, Belgique) et du débit de fuite a été réalisée chez 200 patients atteints de SAOS traités par PPC dont l’ étanchéité de l’ interface était acquise. L’analyse principale a porté sur 1494 séquences de données, classées en trois catégories : absence de fuite (groupe témoin), fuites buccales intermittentes séquentielles (groupe A) et fuite buccale continue isolée (groupe B) (Fig. 1). Résultats Les analyses de régression ont montré que la présence de fuites était associée à une fragmentation accrue du sommeil et à une augmentation des événements obstructifs. Chaque augmentation d’un écart-type du nombre d’épisodes de fuite s’accompagnait d’une hausse de 38,4 % (IC : 34,5 à 42,3) du taux de micro-éveils et de 34 % (IC : 27,4 à 40,5) du taux d’événements obstructifs. Une réduction de la proportion de sommeil N3 (−3,1 à −6,3 %) était également observée durant les périodes de fuite. De plus, par rapport aux séquences témoins, la présence de fuites non intentionnelles s’accompagnait d’un effort respiratoire accru et d’une ouverture buccale plus importante, quantifiée par l’amplitude du signal MJM. Enfin, les tests de causalité de Granger bidirectionnels ont montré que, dans la majorité des séquences (93,6 % dans le groupe A et 91,5 % dans le groupe B), la variabilité de l’amplitude d’ouverture buccale précédait et prédisait efficacement les fluctuations ultérieures du débit de fuite. Cette relation causale n’était pas retrouvée dans le groupe témoin. Conclusion L’ouverture buccale induite par l’effort respiratoire résiduel constitue un déterminant majeur des fuites d’air non intentionnelles chez les patients atteints de SAOS traités par PPC. Ces résultats mettent en évidence l’intérêt clinique d’associer l’enregistrement des MJM au monitorage des fuites, afin d’en préciser l’origine, d’orienter des interventions ciblées pour les réduire et, in fine, d’améliorer significativement l’observance ainsi que l’efficacité du traitement.
Background:Obstructive sleep apnoea (OSA) is often underdiagnosed, highlighting the need for scalable diagnostic alternatives. The SUNSAS study compared a new device for at-home diagnosis of OSA (artificial intelligence [AI]-supported analysis of mandibular jaw movements [MJM]) with polysomnography (PSG) for time to diagnosis and treatment, and patient-reported outcomes. Methods:This prospective, multicentre, randomised, controlled, open-label study was conducted in France (October 2021-October 2024). Adults aged 18-80 years with suspected OSA were randomised (1:1) to undergo diagnostic testing using MJM monitoring (Sunrise) or PSG. Primary endpoints were assessed using hierarchical testing: 1. daytime sleepiness (Epworth Sleepiness Scale [ESS] score) at 3 months post-diagnosis and time to diagnosis; 2. time to treatment; and 3. daytime sleepiness at 3 months post-randomisation. Secondary endpoints included quality of life (Short Form-36, Quebec Sleep Questionnaire), work productivity (Work Productivity and Activity Impairment questionnaire), and positive airway pressure therapy adherence at 3 months after treatment initiation. Findings:Of 849 participants randomised (58·7% male, median age 50 years, body mass index 28·0 kg/m2, apnoea-hypopnoea index 15·2/h), 774 received a diagnosis: 133 no OSA, 239 mild OSA, 220 moderate OSA, and 182 severe OSA. Median time to diagnosis (15 vs. 106 days) and to treatment initiation (50 vs. 124 days) were significantly shorter with MJM analysis versus PSG (both p < 0·01). MJM-based diagnosis was noninferior to PSG in reducing ESS at 3 months after diagnosis (-2·26 vs. -2·29; 95% confidence interval [CI] for difference -0·85, 0·79; p = 0·01), and superior at 3 months post-randomisation (between-group difference: -1·51 (95% CI -2·17, -0·85); p < 0·01). Secondary endpoints also favoured the MJM group. Interpretation:OSA diagnosis based on MJM monitoring with AI-supported analysis is noninferior to PSG in reducing daytime sleepiness at 3 months after diagnosis, while significantly accelerating time to diagnosis and treatment initiation, resulting in earlier improvement in daytime sleepiness. Funding:Sunrise, with support from the French Ministry of Health through the Forfait Innovation programme.
Objectif Déterminer la relation dose-réponse entre le niveau de protrusion mandibulaire et l’effort respiratoire résiduel chez les patients atteints du syndrome d’apnées obstructives du sommeil (SAOS) et traités par orthèse. Méthodes Étude prospective sur 93 patients avec SAOS traités par orthèse (NOA, OrthoApnea, Espagne). La titration est réalisée progressivement selon la persistance ou l’aggravation des symptômes. Des tests de sommeil à domicile, basés sur l’analyse des mouvements mandibulaires (MJM) (Sunrise, Belgique), sont effectués à 3 niveaux de protrusion : minimal, intermédiaire et optimal. L’efficacité du traitement a été évaluée par l’indice d’apnée-hypopnée (IAH) et REMOV, représentant le pourcentage du temps total de sommeil (TTS) en effort respiratoire élevé, soit la durée cumulée des évènements obstructifs. Les réponses optimales pour l’IAH et REMOV sont définies comme une réduction de l’IAH>50 % et REMOV<14 % du TTS. Résultats IAH et REMOV ont montré une réduction progressive avec l’augmentation de la protrusion (Fig. 1). Aux points de titration initial, intermédiaire et optimal, l’IAH a diminué de –10,3, –12,7 et –13,0/h, respectivement, par rapport au niveau de base, tandis que REMOV a diminué de 14,5, 16,8 et 18,6 % du TTS. Cependant, ces indices suivent des trajectoires de réponse différentes : 15,1 % des patients montrent une réponse optimale en REMOV mais pas en IAH en fin de titration, et 5,4 % l’inverse. Le groupe avec une réponse optimale des deux indices présente un IAH médian de 2,2/h, contre un IAH médian de 11,3/h chez celui avec une réponse optimale uniquement en IAH. Conclusion Il existe une relation dose-réponse entre la protrusion mandibulaire et l’effort respiratoire résiduel. Une réponse optimale en IAH et REMOV montre une meilleure efficacité dans la réduction des événements obstructifs, tandis qu’un IAH ou REMOV élevé suggère respectivement des apnées centrales ou de l’effort respiratoire marqué de micro-éveils (MELER). Ces résultats montrent l’intérêt de l’analyse des MJM à domicile pour suivre ces deux indicateurs dans la gestion du traitement par orthèse.
Pediatric obstructive sleep apnea (OSA) is a common yet often underdiagnosed condition, partly due to limited access to polysomnography. Mandibular jaw movement (MJM) analysis offers a promising alternative to conventional home sleep apnea testing in children, capturing the dynamic interactions between respiratory drive and upper airway musculature, enabling accurate identification of, and critical insights into, sleep-disordered breathing events. This technical and practical review provides a structured framework for understanding and interpreting MJM signals during sleep in pediatric patients. It begins with the physiological basis and technical aspects of using a single-point contact device with integrated inertial sensors. It offers step-by-step instructions for interpreting MJM signals, from distinguishing sleep stages to identifying obstructive and central apneas, hypopneas, and respiratory effort-related arousals. The review is accompanied by an atlas of 30 annotated examples that illustrate key MJM signal patterns across scoring tasks. Key findings from several clinical studies on the utility of MJM analysis in pediatric OSA are also summarized. As the demand for accessible and accurate home-based diagnostic tools grows, MJM analysis stands out as an effective option for both the diagnosis and monitoring of pediatric OSA, with the potential to transform routine clinical practice and improve patient access to care.
Rationale: Increased respiratory effort (RE) is a critical feature of obstructive sleep apnea (OSA). Although prior studies have established the efficacy of mandibular advancement device (MAD) therapy in reducing the apnea-hypopnea index (AHI), the impact of MAD therapy on RE burden remains unexplored. Objectives: In this study, we used a validated mandibular jaw movement (MJM) monitoring technology to determine the dose-response relationship between MAD protrusion levels and RE burden measured as the percentage of total sleep time (TST) spent in elevated respiratory effort (REMOV) during MAD titration. Methods: Ninety-three patients with OSA eligible for MAD treatment were included in this prospective cohort study. A subjective titration process involved iterative adjustments based on the persistence or worsening of OSA symptoms. Optimal AHI and REMOV responses were defined as an AHI reduction of >50% and a residual REMOV <14% TST, respectively. MJM-based home sleep tests were conducted at initial, intermediate, and final protrusion levels. The treatment effect on REMOV was estimated by regression analysis. Results: AHI and REMOV reductions increased progressively with higher MAD protrusion levels, with AHI decreasing by 10.3, 12.7, and 13.0 events/h and REMOV by 14.5%, 16.8%, and 18.6% TST across the three titration steps. However, a consistent discrepancy was observed between REMOV and AHI responses: at the end of titration, 68.8% of patients achieved optimal responses for both indices, whereas 15.1% had optimal REMOV response without AHI normalization, and 5.4% showed the reverse. Regression analysis showed a significant dose-response relationship for REMOV, with a 10% TST reduction within the 0-6.5 mm protrusion range and diminishing benefits beyond 6.5 mm. Of note, each millimeter advancement would yield a 2.6% TST (95% confidence interval, -3.0% to -2.1%) improvement in REMOV. Conclusions: Our findings demonstrate a dose-response relationship between the MAD protrusion level and the improvement in RE burden. Optimal responses in both AHI and REMOV signify greater efficacy of MAD therapy in reducing obstructive respiratory events and RE burden. This underscores the benefit of using at-home MJM analysis to monitor these two critical metrics in the management of MAD therapy to achieve better clinical outcomes and enhance MAD titration efficacy.
Rationale: Increased respiratory effort (RE) is a critical feature of obstructive sleep apnea (OSA). While prior studies have established the efficacy of mandibular advancement device (MAD) therapy in reducing the apnea-hypopnea index (AHI), the impact of MAD therapy on RE burden remains unexplored. Objective: In this study, we used a validated mandibular jaw movement (MJM) monitoring technology to determine the dose-response relationship between MAD protrusion levels and RE burden measured as the percentage of total sleep time (TST) spent in elevated respiratory effort (REMOV) during MAD titration. Methods: Ninety-three OSA patients eligible for MAD treatment were included in this prospective cohort study. A subjective titration process involved iterative adjustments based on the persistence or worsening of OSA symptoms. Optimal AHI and REMOV responses were defined as an AHI reduction of greater than 50% and a residual REMOV lower than 14% TST, respectively. MJM-based home sleep tests were conducted at initial, intermediate, and final protrusion levels. The treatment effect on REMOV was estimated by regression analysis. Results: AHI and REMOV reductions increased progressively with higher MAD protrusion levels, with AHI decreasing by -10.3, -12.7, and -13.0 events/h and REMOV by 14.5%, 16.8%, and 18.6% of TST across the three titration steps. However, a consistent discrepancy was observed between REMOV and AHI responses: at the end of titration, 68.8% of patients achieved optimal responses for both indices, while 15.1% had optimal REMOV response without AHI normalization, and 5.4% showed the reverse. Regression analysis showed a significant dose-response relationship for REMOV, with a 10% TST reduction within the 0–6.5 mm protrusion range and diminishing benefits beyond 6.5 mm. Of note, each millimeter advancement would yield a 2.6% TST (95%CI: -3.0; -2.1) improvement in REMOV. Conclusion: Our findings demonstrate a dose-response relationship between the MAD protrusion level and the improvement in RE burden. Optimal responses in both AHI and REMOV signify greater efficacy of MAD therapy in reducing obstructive respiratory events and RE burden. This underscores the benefit of using at-home MJM analysis to monitor these two critical metrics in the management of MAD therapy to achieve better clinical outcomes and enhance MAD titration efficacy.
BackgroundThe polysomnography (PSG) is the gold-standard for obstructive sleep apnea (OSA) syndrome diagnosis and assessment under positive airway pressure (PAP) therapies in children. Recently, an innovative digital medicine solution, including a mandibular jaw movement (MJM) sensor coupled with automated analysis, has been validated as an alternative to PSG for pediatric application.ObjectiveThis study aimed to assess the reliability of MJM automated analysis for the assessment of residual apnea/hypopnea events during sleep in children with OSA treated with noninvasive ventilation (NIV) or continuous PAP (CPAP).MethodsIn this open-label prospective non-randomized multicentric trial, we included children aged from 5 to 18 years with a diagnosis of severe OSA. The children underwent in-laboratory PSG with simultaneous MJM monitoring and at-home recording with MJM monitoring 3 months later. Agreement between PSG and MJM analysis in measuring the residual apnea-hypopnea index (AHI) was evaluated by the Bland-Altman method. The treatment effect on residual AHI was estimated for both PSG and MJM analysis.ResultsFifteen (60% males) children were included with a median age of 12 years [interquartile range 8-15]. Two (17%) were ventilated with NIV and 13 (83%) with CPAP. There was a good agreement between MJM-AHI and PSG-AHI with a median bias of -0.25 (95% CI: -3.40 to +2.04) events/h. The reduction in AHI under treatment was consistently significant across the three measurement methods: in-laboratory PSG and MJM recordings in the laboratory and at home.ConclusionAutomated analysis of MJM is a highly reliable alternative method to assess residual events in a small population treated with PAP therapies.
PURPOSE:This review aims to highlight the pivotal role of the mandibular jaw movement (MJM) signal in advancing artificial intelligence (AI)-powered technologies for diagnosing obstructive sleep apnea (OSA). METHODS:A scoping review was conducted to evaluate various aspects of the MJM signal and their contribution to improving signal proficiency for users. RESULTS:The comprehensive literature analysis is structured into four key sections, each addressing factors essential to signal proficiency. These factors include (1) the comprehensiveness of research, development, and application of MJM-based technology; (2) the physiological significance of the MJM signal for various clinical tasks; (3) the technical transparency; and (4) the interpretability of the MJM signal. Comparisons with the photoplethysmography (PPG) signal are made where applicable. CONCLUSIONS:Proficiency in biosignal interpretation is essential for the success of AI-driven diagnostic tools and for maximizing the clinical benefits through enhanced physiological insight. Through rigorous research ensuring an enhanced understanding of the signal and its extensive validation, the MJM signal sets a new benchmark for the development of AI-driven diagnostic solutions in OSA diagnosis.