Does oral appliance efficacy in treating obstructive sleep apnea depend on the appliance specialist's experience?

PURPOSE: In France, oral appliances (OAs) are the first-line treatment for moderate and second-line treatment for severe obstructive sleep apnea-hypopnea syndrome. In general, the sleep specialist refers his/her patient to the appliance specialist for the impressions and the fitting. However, is there a relationship between the volume of activity of the appliance specialist and the efficacy of this device? METHODS: Our unit includes seven appliance otolaryngology specialists whose activities are highly variable (number of patients varying by a factor of almost 10). Data from a prospective follow-up registry of patients treated with an OA for moderate and severe obstructive sleep apnea-hypopnea syndrome were studied, and differences in outcomes between practitioners in the team were sought. RESULTS: Among 859 patients, OAs significantly reduced the apnea-hypopnea index. Even if the patients were not completely comparable from one practitioner to another, there was a significant heterogeneity in efficacy (complete or partial response of the apnea-hypopnea index and failure of OAs) between practitioners (p = 0.0038; 0.0011; 0.0007 respectively), with better results in practitioners with a higher level of OA activity. CONCLUSION: The findings suggest that it may be preferable to refer patients to OA practitioners who see a higher volume of patients with moderate or severe obstructive sleep apnea-hypopnea syndrome treated with an OA.

Clinical efficacy of the Invisalign mandibular advancement appliance: A retrospective investigation.

INTRODUCTION: This retrospective investigation aimed to determine whether the achieved changes in the treatment of Class II malocclusion were the same as those planned after the prescribed wear of an initial phase of Invisalign treatment with the mandibular advancement appliance (MAA) (Align Technology, Santa Jose, Calif). METHODS: All patients treated with the MAA and who satisfied inclusion/exclusion criteria were selected from a database of 16,500 patients treated with clear aligners by 16 orthodontists. The pretreatment, planned, and achieved overjet measurements were documented from data provided in Align Technology's software facility, ClinCheck. Changes in intermaxillary anteroposterior (AP) first permanent molar (FPM) relationships were evaluated using Geomagic Control X (3D systems, Rock Hill, SC) metrology software. RESULTS: Most of the 195 patients who satisfied the inclusion criteria were females (n = 104; 53.3%). The mean age was 12.62 ± 2.20 years. The pretreatment overjet was reduced from 6.49 ± 2.86 mm to 4.61 ± 2.22 mm after prescribed MAA wear, which was 42.5% of the planned outcome. The pretreatment AP FPM reduced from 3.14 ± 1.95 mm to 2.24 ± 2.51 mm, which was 31.3% of that planned. Thirty-eight (19.5%) patients experienced an increase in overjet where a reduction was planned. CONCLUSIONS: Less than half of the planned overjet reduction and less than a third of the planned AP FPM correction were achieved with the MAA. Almost 20% of patients completed the MAA phase of treatment with an increased overjet despite a reduction being planned.

Exploring long-term changes and influencing factors of the upper airway in patients with a skeletal Class II relationship after mandibular advancement with maxillary setback surgery: A comprehensive 2-year follow-up investigation.

INTRODUCTION: The objective of this study was to investigate the 2-year postoperative change and influencing factors of the upper airway after mandibular advancement with maxillary setback surgery for patients with a skeletal Class II relationship. METHODS: Fifty-seven participants who underwent mandibular advancement with maxillary setback surgery were enrolled consecutively. Cone-beam computed tomography was performed preoperatively, 3 months postoperatively (T1), and 2 years (T2) postoperatively. All parameters were measured using Dolphin Imaging software (Dolphin Imaging and Management Solutions, Chatsworth, Calif). RESULTS: The total volume (V), minimum cross-sectional area (CSAmin), and glossopharynx increased significantly in both the short-term (V, 13.33%; CSAmin, 33.03%; glossopharynx, 26.73%) and long-term (V, 10.19%; CSAmin, 23.18%; glossopharynx, 18.27%) after the surgery. Mandibular advancement, mandibular width increase, preoperative CSAmin, and body mass index (BMI) significantly affected 2-year postoperative V increases. Mandibular advancement and BMI significantly affected 2-year postoperative glossopharynx increases. Backward movement of point PNS may lead to a reduction of the nasopharynx; however, downward movement of point PNS, upward movement of point A, and increased maxillary width may compensate for this effect by increasing the likelihood of the nasopharynx opening. Furthermore, mandibular body length at T1 is positively associated with relapse rate ([T2 - T1] / T1) of V and CSAmin. CONCLUSIONS: Mandibular advancement amount, mandibular width increase, preoperative CSAmin, and BMI are the 4 factors for long-term V changes. Patients with a longer mandibular body length might have a lower relapse rate.

Australasian Sleep Association position statement on consensus and evidence based treatment for primary snoring.

Primary snoring impacts a significant portion of the adult population and has the potential to significantly impair quality of life. The purpose of these guidelines is to provide evidence-based recommendations to assist Australasian practitioners in the management of adult patients who present with primary snoring without significant obstructive sleep apnoea. The Timetable, Methodology and Standards by which this Position Statement has been established is outlined in the Appendix S1. The main recommendations are: Weight loss, and reduced alcohol consumption should be recommended, where appropriate If clinical judgement dictates, benzodiazepine and opioid reduction or avoidance may be advised Positional therapy should be considered in supine dominant snorers In dentate patients, Mandibular advancement devices (MAD) should be recommended as a first line treatment following assessment by both an appropriate Dentist and Sleep physician Continuous positive airway pressure (CPAP) devices may be recommended in patients with primary snoring in those already committed to their use or willing to try Surgical treatment of primary snoring by an appropriately credentialled surgeon may be advised and includes nasal (adjunctive), palatal and other interventions This position statement has been designed based on the best available current evidence and our combined expert clinical experience to facilitate the management of patients who present with primary snoring. It provides clinicians with a series of both non-surgical and surgical options with the aim of achieving optimal symptom control and patient outcomes. This is the first such set of recommendations to be established within Australasia and has also been reviewed and endorsed by the Australasian Sleep Association.

Effects of CPAP and Mandibular Advancement Devices on depressive symptoms in patients with obstructive sleep apnea: a meta-analysis of randomized controlled trials.

PURPOSE: Studies show that patients with obstructive sleep apnea (OSA) are more likely than the general population to have psychological disorders such as depression. However, it is less clear how OSA treatment affects this association. This meta-analysis aimed to assess whether or not continuous positive airway pressure (CPAP) and mandibular advancement devices (MADs) reduce depression symptoms in patients with OSA. METHODS: We searched Pubmed, Embase, Web of Science, and Cochrane Library from creating the databases until November 2022. Our analysis included RCTs that examined CPAP and MAD treatment effectiveness for depression in patients with OSA. RESULTS: We identified 17 CPAP studies comprising 1,931 patients for inclusion in the meta-analysis. The results of the meta-analysis using a fixed effects model found that CPAP improved depressed mood in patients with OSA relative to controls (SMD = 0.27;95% CI:0.18,0.36), with small heterogeneity among trials (I2 = 8.1% < 50%, P = 0.359). We performed subgroup analyses on three factors: the length of trial follow-up, patient adherence data, and depression assessment scales. The meta-analysis also identified six MAD studies involving 315 patients. According to this analysis, there was no heterogeneity between studies (I2 = 0%, P = 0.748). MADs did not significantly improve depression symptoms compared to controls, indicating a combined effect of SMD = 0.07 (95% CI: - 0.15,0.29), P > 0.05. CONCLUSION: The present findings confirm that CPAP may improve depressive symptoms in patients with OSA. However, the review results suggest that MADs have no significant effect on depressive symptoms in patients with OSA, a finding that is different from the results of previous meta-analyses.

Comparative efficacy of mandibular advancement devices in obstructive sleep apnea: a network meta-analysis.

PURPOSE: To analyze relative efficacies of mandibular advancement devices (MAD) in sleep apnea treatment. METHODS: From eligible randomized controlled trials (RCT), MADs were classified based on their mechanistic designs. Data on apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), nadir oxygen saturation (minSaO2), and sleep efficiency (SE%) from RCTs were then analyzed in network meta-analyses, and relative ranking of different MADs was computed based on P scores (a method of ranking similar to SUCRA). Similar analyses were conducted based on the different brands of MADs. RESULTS: There were no statistically significant differences between MADs in any of the outcomes analyzed. However, the P-scores, based on the point estimates and standard errors of the network estimates, ranked some MADs higher than others in some of the outcomes. Of the different mechanistic designs, the highest P scores were achieved for attached midline traction (P score = 0.84) and unattached bilateral interlocking (P score = 0.78) devices for AHI reduction, attached bilateral traction (P score = 0.78) and unattached bilateral interlocking (P score = 0.76) for ESS, monobloc (P score = 0.91) and unattached bilateral interlocking (P score = 0.64) for minSaO2, and unattached bilateral interlocking (P score = 0.82) and attached bilateral traction (P score = 0.77) for SE%. Notable findings in the network meta-analyses based on MAD brands, of the limited number of studies that specified them were the effects of SomnoDent Flex™, TAP™, and IST® in their effects on AHI reduction, with P scores of 0.94, 0.83, and 0.82, respectively. Monobloc decreased supine-AHI the most (- 44.46 [- 62.55; - 26.36], P score = 0.99), and unattached bilateral interlocking had the greatest effect on REM-AHI (- 11.10 [- 17.10; - 5.10], P score = 0.87). CONCLUSIONS: Findings from this study show clinically (but not statistically) significant differences between MADs in terms of their relative efficacy when analyzed for different sleep apnea treatment outcomes and sleep apnea phenotypes.

An interim oral appliance as a screening tool during drug-induced sleep endoscopy to predict treatment success with a mandibular advancement device for obstructive sleep apnea.

PURPOSE: Previous studies have shown a wide range of efficacy (29 to 71%) of a mandibular advancement device (MAD) in the treatment of obstructive sleep apnea (OSA). Currently, the ability to preselect suitable patients for MAD therapy based on individual characteristics related to upper airway collapsibility is limited. We investigated if the use of non-custom interim MAD during drug-induced sleep endoscopy (DISE) could be a valuable screening tool to predict MAD treatment outcome. METHODS: In a single-center prospective study including a consecutive series of patients with OSA, we compared DISE outcomes with a MAD in situ with polysomnography results after 3 months of using the same MAD that was used during DISE. RESULTS: Of 41 patients who completed the study, the median apnea-hypopnea index (AHI) was 16.0 events/h [IQR 7.4-23.4]. Respiratory outcomes on polysomnography, including apnea index (AI), total AHI, AHI in supine position, and oxygen desaturation index, all significantly improved after 3 months of MAD treatment. With complete improvement of the upper airway obstruction with the MAD in situ during DISE in supine position, patients were 6.3 times more likely to be a responder to MAD treatment compared to patients with a persisting complete obstruction, although not statistically significant (OR 6.3; 95%CI 0.9-42.7; p = 0.060). CONCLUSION: The potential predictive value with regard to MAD therapy outcomes of the use of an interim MAD during DISE would be an important finding, since the prediction of MAD therapy outcome is of great clinical and scientific interest. A study with a larger cohort should be performed to further investigate our findings.

Anatomical phenotype of obstructive sleep apnea patients based on cluster analysis.

OBJECTIVES: To generate a novel subtype of obstructive sleep apnea (OSA) based on anatomical features and verify the differences in the response of different subtypes to orthodontic treatment, thus providing a theoretical reference for clinical decision-making. MATERIALS AND METHODS: A K-means cluster analysis was performed for this retrospective serial study, which includes 722 OSA patients, aged 44.0 (36.0, 54.0) years, 80.2% male, with apnea-hypopnea index (AHI) of 23.2 (13.4, 39.6) events·h-1 , and body mass index (BMI) of 25.47 ± 3.00 kg·m-2 . All samples were divided into three subtypes based on AHI, BMI, and five variables of craniofacial measurements. Sixty-seven cases with mandibular advancement devices (MAD) therapeutic results were further applied to validate the efficacy and side effects of this treatment in different subtypes. RESULTS: Two hundred and thirty patients (31.9%) were characterized as cluster 1: AHI of 17.65 (11.80, 30.42) events·h-1 , BMI of 23.65 ± 2.62 kg·m-2 , with skeletal Class II high-angle shape. Cluster 2 included 278 patients (38.5%): AHI of 17.00 (11.00, 26.48) events·h-1 , BMI of 25.36 ± 2.53 kg·m-2 , soft palate length (SPL) of 39.25 mm (36.12, 42.20), with basically normal skeleton and normal airway size. Cluster 3, consisting of 214 patients (29.6%), exhibited a combination of anatomical deformity and obesity, with the highest AHI and BMI of 45.35 (30.42, 62.53) events·h-1 and 27.57 ± 2.59 kg·m-2 respectively, but less deformity degree than cluster 1. Cluster 2 had the highest response rate and relatively mild side effects with MAD. CONCLUSIONS: Orthodontic treatment based on anatomical morphology could exert a better effect on mild-moderate OSA patients with mild skeletal deformity.

The long-term results of modified maxillomandibular advancement in Asian OSA patients.

OBJECTIVE: Maxillomandibular advancement (MMA) surgery is considered a highly successful treatment for obstructive sleep apnea (OSA). Various modifications to the technique have been described. We aim to study the long-term results in Asian patients who underwent a modified MMA procedure intended to avoid bimaxillary protrusion and which involved four-quadrant bicuspid extractions with posterior maxillary alveolar setback. METHOD: A review of operative logs from 2000 to 2003 was conducted to identify Asian patients who underwent modified MMA during that period, for treatment of moderate and severe OSA. Sleep indices and psychometric performances were prospectively analyzed. RESULTS: Eight Asian patients were included. The mean length of follow-up was 14.4 years (range: 13.0-16.5). Mean preoperative apnea-hypopnea index (AHI) was 48.9 (range: 19.0 to 84.8). Mean post-operative AHI was 31.6 (range: 6.2 to 79.5). This reduction was statistically significant (p<0.05). Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire (FOSQ) revealed that majority of the patients (75%) did not have excessive daytime somnolence and all patients had high FOSQ totalled scores (mean 17.7, range 11.8 to 20), indicating good functional performance. CONCLUSION: This series is the longest follow-up of an Asian cohort who underwent modified MMA. With a mean follow-up of 14.4 years, improvement in AHI is still observed but not at a degree as large as prior studies with shorter lengths of follow-up. The purported efficacy of MMA for Caucasian patients may not be reproducible in Asian patients and long-term sustainability of this treatment's efficacy requires rigorous evaluation.

Maxillomandibular Advancement for Obstructive Sleep Apnea Syndrome: Long-Term Results of Respiratory Function and Reverse Face-Lift.

PURPOSE: Scientific literature considers maxillomandibular advancement (MMA) as the most effective surgical treatment for the management of adult obstructive sleep apnea syndrome (OSAS). Maxillomandibular advancement enlarges the pharyngeal space by expanding the skeletal framework. Moreover, it projects the soft tissue of the cheeks, the mouth, and the nose in the aging face, which is characterized by multiple signs affecting the middle third and the lower third. The potential of orthognathic surgery (double jaw surgical advancement) of expanding the skeletal foundation to increase the facial drape support and to rejuvenate the face by a "reverse face-lift" is now recognized. The aim of this study was to review the surgical outcomes after MMA in terms of respiratory function and assessment of facial esthetics. METHODS: We retrospectively reviewed the charts of all patients affected by OSAS who underwent maxillomandibular advancement between January 2010 and December 2015 in 2 tertiary hospitals (IRCCS Policlinico San Martino of Genoa and IRCCS Policlinico Ca' Granda of Milan). During the postoperative follow-up examination, all patients underwent polysomnographic examination and esthetic assessment to evaluate the respiratory function and facial rejuvenation after double jaw surgical advancement. RESULTS: The final study sample included 25 patients (5 females, 20 males). The overall success rate of the surgical treatment (apnea/hypopnea index, AHI <20) was 79%; the overall rate of surgical cure (AHI <5) was 47%. Twenty-three patients (92%) showed a degree of rejuvenation after MMA. CONCLUSIONS: Maxillomandibular advancement is currently the most effective surgical treatment for the management of OSAS in adult patients who are not responders to medical treatment. "Reverse face-lift" is the consequence of the double jaw surgical advancement.

The Efficacy of 3D Virtual Surgery, CAD/CAM, and 3D Printing Technology for Maxillomandibular Advancement in Obstructive Sleep Apnea Patients.

OBJECTIVE: Maxillomandibular advancement (MMA) is the most effective surgical method for treating obstructive sleep apnea, and it moves the maxillomandibular complex forward to increase the entire upper airway volume. By using 3-dimensional (D) virtual surgery, computer-aided design/computer-aided manufacturing, and 3D printing technologies, it is possible to overcome all the limitations of conventional methods. MATERIALS AND METHODS: In this study, (modified) MMA was performed by applying 3D technologies to obstructive sleep apnea patients. Virtual surgery was done as surgical plan, cutting guides, and customized plates were made by computer-aided design/computer-aided manufacturing and 3D printing technologies for surgical procedures. RESULTS: After surgery, all patients improved their appearance, quality of sleep, and sleep apnea level were dramatically improved. Through these results, it was found that there are many advantages in using 3D technologies for preparing and implementing MMA. CONCLUSIONS: It was confirmed that the accuracy and efficiency of surgery were increased by applying 3D technologies. This suggests that 3D technologies are very useful tools in surgical area.

Mandibular advancement analysis among orthodontists, lay people and patients in class II malocclusion subjects. A three-dimensional imaging study.

OBJECTIVE: To evaluate the acceptance of orthodontists, laypeople and the patient when progressive mandibular advancements are performed in class II subjects with mandibular retrognathism. SETTING AND SAMPLE: 3D images were obtained by an optical surface scanning of fifteen individuals (12 males and three females, mean age of 23 years and 8 months) with mandibular retrognathism in three mandibular positions: maximum intercuspation (MIC) and progressive mandibular advancement of 2 and 4 mm. METHODS: The images (n = 45) were evaluated through a scale by two groups of panellist, 20 orthodontists, 20 laypeople and by the patients themselves (n = 15). The participants evaluated and rated each video and give scores between 0 and 10, according to their perception of facial harmony. MANOVA for repeated measures was used for intra- and intergroup differences and to evaluate the patients' self-perception. RESULTS: Laypeople reported better face acceptance than orthodontists in MIC and progressive mandibular advancement of 2 and 4 mm (P < .0001). 80% of the patients evaluated their own face as pleasant in MIC. Around half of them did not note significant difference following mandibular advancement of 2 mm as compared with MIC and even two-third attributed lower scores when the mandible was advanced 4 mm. CONCLUSION: A high variability was observed among all groups of raters. Patient´s opinion should be taken into account when mandibular advancement of 4 mm or more is planned. This study suggests that a thorough discussion of facial changes resulting from mandibular advancement should be carried out among professionals, parents and patients.

Is Intensive Care Unit Monitoring Necessary After Maxillomandibular Advancement for Management of Obstructive Sleep Apnea?

PURPOSE: Maxillomandibular advancement (MMA) is an accepted treatment modality for obstructive sleep apnea. The purpose of this study was to evaluate the incidence of complications requiring an intensive care unit (ICU) level of care and the necessity of routine overnight ICU airway monitoring after MMA. PATIENTS AND METHODS: This was a retrospective cohort study of patients undergoing MMA at Massachusetts General Hospital from 2003 to 2020. The primary predictor variable was postoperative admission to the ICU versus post anesthesia care unit (PACU) or ward. The primary outcome variable was grade IV or V complications as scored using the Clavien-Dindo classification system. The secondary outcome variables included postoperative SpO2 nadir and length of hospital stay. Descriptive and bivariate statistics were computed to measure the association between complications and predictor variables. RESULTS: The study sample consisted of 104 patients (74.0% male, mean age 37.6 ± 12.1 years), 61 of whom were admitted to the ICU (58.7%). During the initial 24 hours of airway monitoring, the mean SpO2 nadir was 93.7 ± 2.59% for patients admitted to the ICU compared with 94.0 ± 6.56% for patients admitted to the PACU or ward (P = .862). Patients experienced 2 grade IV complications (1.92%) and no grade V complications, with no statistical association between complications and postoperative admission location (P = 1.000). Age (P = .002) and operative time (P = .046) were the only variables statistically associated with grade IV or V complications. There was no difference in length of hospital stay between patients admitted to the ICU (2.64 ± 1.37 days) versus PACU or ward (2.58 ± 1.62 days). CONCLUSIONS: The incidence of complications requiring ICU-level care after MMA for obstructive sleep apnea is low. Additional studies are warranted to guide development of feasible, cost-effective perioperative protocols for patients undergoing MMA.

Impact of counterclockwise rotation of the occlusal plane on the mandibular advancement, pharynx morphology, and polysomnography results in maxillomandibular advancement surgery for the treatment of obstructive sleep apnea patients.

PURPOSE: Evaluate the impact of counterclockwise rotation of the occlusal plane (CCWROP) on pharynx morphology and polysomnography in maxillomandibular advancement (MMA) surgery to treat obstructive sleep apnea (OSA) patients. METHODS: Prospective clinical trial of patients with OSA treated by MMA. Computed tomography and polysomnography were performed pre- and postoperatively and the parameters were compared. The surgery classified the patients into two groups: with (R) and without (NR) CCWROP. RESULTS: The study sample comprised 38 individuals: R (n = 19) and NR (n = 19). An anterior mandible advancement of 0.71 mm was identified for each degree of CCWROP (p < 0.001). As for polysomnography, the apnea-hypopnea index was reduced by 80% and 62% in R and NR, showing final values of 6.8 and 13.0, respectively. The apnea index changed equally in both groups. Reduction of 68 and 26% in the hypopnea index was observed for R and NR, respectively, with no statistically significant difference. Total volume increased by 45% in R and 30% in NR. Retropalatal and retrolingual volumes increased by 49% and 4% in R and 43% and 15% in NR, respectively. The minimum axial area increased by 92% in the retropalatal region and 97% in the retrolingual region in R, whereas these increases were of 76% and 31% in NR, respectively. CONCLUSION: Anterior mandibular advancement of 0.71 mm for each degree of CCWROP is of great importance for surgical planning. As a result of this resource, individuals in R presented better results than those in NR in all parameters assessed, especially regarding the retrolingual region.

Pediatric Obstructive Sleep Apnea Syndrome: Emerging Evidence and Treatment Approach.

OSA pediatric subjects suffer from episodes of upper airway obstruction that can be partial or complete, with atypical sleep patterns and blood-gas level alteration. If poor treated and/or diagnosed, it can cause cardiovascular disease, learning difficulties, behavioural issues, and retardation of growth. In the literature, there are conflicting evidence about OSA assessment and treatment in pediatric age, so the aim of this paper is to highlight the multidisciplinary approach in the management of sleep disorders, stressing the role of the pediatric dentist in both diagnosing and treating the OSAS in children, according to the current evidence of the treatment options effectiveness of the syndrome itself. Conclusions. Scientific evidence shows that OSAS management requires a multidisciplinary approach in order to make an early diagnosis and a correct treatment plan. The orthodontic treatment approach includes orthopedic maxillary expansion and mandibular advancement using intraoral appliances. Hence, the orthodontist and the pediatric dentist play an important role not only in early diagnosis but also in the treatment of pediatric OSAS.

A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.

PURPOSE: In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA. METHODS: This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects. RESULTS: In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up. CONCLUSIONS: This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.

Dose-dependent effects of mandibular advancement on optimal positive airway pressure requirements in obstructive sleep apnoea.

BACKGROUND: Implementation of mandibular advancement splint (MAS) therapy as first-line treatment for obstructive sleep apnoea (OSA) is hindered by inter-individual variability of treatment outcomes and lack of robust patient selection methods. Optimal continuous positive airway pressure (CPAP) requirement provides an estimate of airway collapsibility severity, and high CPAP requirements predict MAS therapy failure in retrospective studies. Thus, understanding the effects of mandibular advancement on optimal CPAP requirements may enhance optimisation of patient selection for MAS therapy. OBJECTIVE: This study aims to determine dose-dependent effects of mandibular advancement on optimal CPAP requirements in OSA. METHODS: Prior to MAS therapy initiation, participants with OSA (apnoea-hypopnea index (AHI) > 10 events/h) underwent a research polysomnogram in which a remotely controlled mandibular positioner (RCMP) was used to determine dose-response effects of varying mandibular advancement positions (0% 'habitual bite' and 25, 50, 75 and 100% of maximum mandibular advancement, in random order) on optimal CPAP requirements. A separate polysomnography determined treatment outcome. Data are presented as mean ± SD or median (1st-3rd quartiles). RESULTS: Seventeen participants (age = 47 ± 9 years, body mass index = 26 kg/m2 (23-27), apnoea-hypopnea index = 18 events/h (14-44) and minimal oxygen saturation = 84 ± 7%) were studied. Optimal CPAP requirements were reduced with mandibular advancement in a dose-dependent manner (8.9 ± 2.4 vs. 7.9 ± 2.8, 6.4 ± 1.8, 5.7 ± 1.9 and 4.9 ± 1.8 cmH2O; respectively, p < 0.0001). Compared with non-responders, responders to MAS therapy had lower AHI, lower arousal index and greater MinSaO2 at baseline. Optimal CPAP requirements at 0% mandibular advancement (or other positions) were not different between groups. CONCLUSIONS: Increasing mandibular advancement lowers optimal CPAP requirements in a dose-dependent manner. This supports prior work indicating a beneficial effect of MAS on upper airway collapsibility.

Effects of transverse maxillomandibular distraction osteogenesis on obstructive sleep apnea syndrome and on the pharynx.

PURPOSE: To assess the effects of transverse maxillomandibular distraction osteogenesis (TMDO) on the treatment of obstructive sleep apnea (OSA) and on the morphology of the pharynx. METHODS: A clinical trial was conducted with seven patients with OSA and with transverse maxillomandibular deficiency, two women and five men aged on average 41.16 ± 10.9 years on the day of surgery. All participants were submitted to computed tomography (CT) and full-night polysomnography (PSG) before and approximately 9 months after surgery. A 95% confidence interval was defined. RESULTS: The AHI and RDI of the participants were reduced by about 62% (from 27.65 ± 36.65 to 10.73 ± 11.78, p = 0.031 and from 41.21 ± 32.73 to 15.30 ± 13.87, p = 0.015, respectively). The airway showed a surprising mean reduction in volume of 10% (from 5.78 ± 2.53 to 4.71 ± 1.42, p = 0.437, for the upper pharynx; from 6.98 ± 2.23 to 6.23 ± 2.05, p = 0.437, for the lower pharynx; and from 12.76 ± 1.56 to 10.94 ± 2.42, p = 0.625, for the total pharynx). However, the site of the smallest area of the pharynx was considerably increased both in the anteroposterior and transverse direction and in its total area (from 0.88 ± 7.11 to 0.99 ± 0.39, p = 0.625; from 1.78 ± 0.81 to 2.05 ± 0.61, p = 0.812; and from 0.99 ± 0.74 to 1.40 ± 0.51, p = 0.180, respectively). CONCLUSION: TMDO proved to be efficient in reducing or curing OSA, producing modifications of upper pharynx morphology with an increase of the smallest area of the pharynx.

Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial.

RATIONALE: Custom-made mandibular advancement devices (MADs) are reported as providing higher efficacy rates compared with thermoplastic heat-moulded MADs but at the price of higher costs and treatment delays. OBJECTIVE: To determine whether a thermoplastic heat-moulded titratable MAD (ONIRIS; ONIRIS SAS, Rueil Malmaison, France) is non-inferior to a custom-made acrylic titratable MAD (TALI; ONIRIS SAS, Rueil Malmaison, France) for obstructive sleep apnoea (OSA). METHODS: We conducted a multicentre, open, randomised controlled trial of patients with OSA refusing or not tolerating continuous positive airway pressure (CPAP). Participants were randomly assigned to a thermoplastic heat-moulded titratable device or a custom-made acrylic device for 2 months with stratification by centre and OSA severity. The non-inferiority primary outcome was a ≥50% reduction in apnoea-hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months. The non-inferiority margin was preset as a difference between groups of 20% for the primary outcome in the per-protocol analysis. MAIN RESULTS: Of 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean body mass index 26 [SD, 2.7] kg/m2; mean AHI 26.6/hour [SD, 10.4]), 100 received TALI and 98 ONIRIS. In per-protocol analysis, the response rate was 51.7% in the TALI group versus 53.6% in the ONIRIS group (absolute difference 1.9%; 90% CI: 11% to 15%, within the non-inferiority margin). Effectiveness was the same for severity, symptoms, quality of life and blood pressure reduction. Patients in ONIRIS group reported more side effects and adherence was slightly better with TALI. CONCLUSION: In patients with OSA refusing or not tolerating CPAP, the thermoplastic heat-moulded titratable MAD was non-inferior in the short-term to the custom-made acrylic MAD. TRIAL REGISTRATION NUMBER: NCT02348970.

Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial.

Systemic inflammation and metabolic disorders are among the mechanisms linking obstructive sleep apnoea (OSA) and cardiovascular disease (CVD). In 109 patients with severe OSA and no overt CVD, biomarkers of inflammation (C reactive protein, interleukin-6, tumour necrosis factor-α and its receptors, adiponectin, leptin and P-selectin), glucose and lipid metabolism, and N-terminal pro-brain natriuretic peptide, were measured before and after 2 months of treatment with a mandibular advancement device (MAD) (n=55) or a sham device (n=54). MAD reduced the Apnoea-Hypopnoea Index (p<0.001) but had no effect on circulating biomarkers compared with the sham device, despite high treatment adherence (6.6 hour/night). TRIAL REGISTRATION NUMBER: NCT01426607.