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Study Objectives: Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure for the management of obstructive sleep apnea (OSA). The ORthèse d'avanCée mAndibulaire dans le traitement en DEuxième intention du SAHOS sévère (ORCADES) study is investigating the long-term effectiveness of MAD therapy in patients with OSA who refused or were intolerant of continuous positive airway pressure. Five-year follow-up data are presented., Methods: Data were available in 172 of 331 patients treated with a custom-made computer-aided design/computer-aided manufacturing biblock MAD (Narval CC; ResMed, Saint-Priest, France). The primary end point was treatment success (≥50% decrease in apnea-hypopnea index from baseline)., Results: Five-year treatment success rates were 52% overall and 25%, 52%, and 63%, respectively, in patients with mild, moderate, or severe OSA. This reflects a decline over time vs 3-6 months (79% overall) and 2 years (68%). Rates declined in all patient subgroups but to the greatest extent in patients with mild OSA. The slight worsening of respiratory parameters over time was not associated with any relevant changes in sleepiness and symptoms. Moderate or severe OSA at baseline, treatment success at 3-6 months, and no previous continuous positive airway pressure use were significant independent predictors of 5-year treatment success on multivariate analysis. No new safety signals emerged during long-term follow-up. The proportion of patients using their MAD for ≥4 h/night on ≥4 days/wk was 93.3%; 91.3% of patients reported device use of ≥6 h/night at 5 years. At 5-year follow-up, 96.5% of patients reported that they wanted to continue MAD therapy., Conclusions: Long-term MAD therapy remained effective after 5 years in >50% of patients, with good levels of patient satisfaction and adherence., Citation: Vecchierini MF, Attali V, Collet JM, et al. Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. J Clin Sleep Med . 2021;17(8):1695-1705., (© 2021 American Academy of Sleep Medicine.)

Purpose: Obstructive sleep apnea (OSA) may increase the risk of severe COVID-19; however, the level of potential modulation has not yet been established. The objective of the study was to determine the association between high risk of OSA, comorbidities, and increased risk for COVID-19, hospitalization, and intensive care unit (ICU) treatment., Methods: We conducted a cross-sectional population-based web survey in adults in 14 countries/regions. The survey included sociodemographic variables and comorbidities. Participants were asked questions about COVID-19, hospitalization, and ICU treatment. Standardized questionnaire (STOP questionnaire for high risk of OSA) was included. Multivariable logistic regression was conducted adjusting for various factors., Results: Out of 26,539 respondents, 20,598 (35.4% male) completed the survey. Mean age and BMI of participants were 41.5 ± 16.0 years and 24.0 ± 5.0 kg/m 2 , respectively. The prevalence of physician-diagnosed OSA was 4.1% and high risk of OSA was 9.5%. We found that high risk of OSA (adjusted odds ratio (aOR) 1.72, 95% confidence interval (CI): 1.20, 2.47) and diabetes (aOR 2.07, 95% CI: 1.23, 3.48) were associated with reporting of a COVID-19 diagnosis. High risk for OSA (aOR 2.11, 95% CI: 1.10-4.01), being male (aOR: 2.82, 95% CI: 1.55-5.12), having diabetes (aOR: 3.93, 95% CI: 1.70-9.12), and having depression (aOR: 2.33, 95% CI: 1.15-4.77) were associated with increased risk of hospitalization or ICU treatment., Conclusions: Participants at high risk of OSA had increased odds of having COVID-19 and were two times more likely to be hospitalized or treated in ICU.

Obstructive sleep apnoea (OSA) is highly prevalent and is a recognised risk factor for motor vehicle accidents (MVA). Effective treatment with continuous positive airway pressure has been associated with a normalisation of this increased accident risk. Thus, many jurisdictions have introduced regulations restricting the ability of OSA patients from driving until effectively treated. However, uncertainty prevails regarding the relative importance of OSA severity determined by the apnoea-hypopnoea frequency per hour and the degree of sleepiness in determining accident risk. Furthermore, the identification of subjects at risk of OSA and/or accident risk remains elusive. The introduction of official European regulations regarding fitness to drive prompted the European Respiratory Society to establish a task force to address the topic of sleep apnoea, sleepiness and driving with a view to providing an overview to clinicians involved in treating patients with the disorder. The present report evaluates the epidemiology of MVA in patients with OSA; the mechanisms involved in this association; the role of screening questionnaires, driving simulators and other techniques to evaluate sleepiness and/or impaired vigilance; the impact of treatment on MVA risk in affected drivers; and highlights the evidence gaps regarding the identification of OSA patients at risk of MVA., Competing Interests: Conflict of interest: M.R. Bonsignore has nothing to disclose. Conflict of interest: W. Randerath reports grants and personal fees for lectures from Philipps Respironics, Heinen & Löwenstein and Resmed, outside the submitted work. Conflict of interest: S. Schiza has nothing to disclose. Conflict of interest: J. Verbraecken reports grants and personal fees for advisory board work from ResMed and Bioprojet, personal fees for consultancy from Philips, personal fees for lectures from Sanofi, Agfa-Gevaert, Springer and AstraZeneca, grants and personal fees for study participation from Jazz Pharmaceutics, grants and personal fees for lectures from SomnoMed, grants from AirLiquide, Westfalen Medical, Vivisol, Total Care, Medidis, Fisher & Paykel, Wave Medical, OSG, Mediq Tefa, NightBalance, Heinen & Löwenstein, Accuramed, Bekaert Deslee Academy and UCB Pharma, outside the submitted work. Conflict of interest: M.W. Elliott has nothing to disclose. Conflict of interest: R. Riha has nothing to disclose. Conflict of interest: F. Barbe has nothing to disclose. Conflict of interest: I. Bouloukaki has nothing to disclose. Conflict of interest: A. Castrogiovanni has nothing to disclose. Conflict of interest: O. Deleanu has nothing to disclose. Conflict of interest: M. Goncalves has nothing to disclose. Conflict of interest: D. Leger reports grants from grants from Philips (Netherlands), Vanda (USA), Sanofi, Vitalaire International, Merck, Jannsen, Jazz and RYTHM outside the submitted work. Conflict of interest: O. Marrone has nothing to disclose. Conflict of interest: T. Penzel reports grants from Cidelec and Philips, personal fees for consultancy from Heel Pharmaceuticals, personal fees for advisory board work from Bayer, outside the submitted work; and is a shareholder of Advanced Sleep Research, Somnico, Nukute, and The Siestagroup GmbH. Conflict of interest: S. Ryan has nothing to disclose. Conflict of interest: D. Smyth has nothing to disclose. Conflict of interest: C. Turino has nothing to disclose. Conflict of interest: W.T. McNicholas has nothing to disclose., (Copyright ©ERS 2021.)

Objective/background: Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented., Patients/methods: OSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3-6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI])., Results: Of 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3-6 months and absence of nocturia at 3-6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment., Conclusions: Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Purpose: Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS., Methods: The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (≥ 50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (< 5/h, < 10/h, < 15/h)., Results: Overall treatment success rates were 89% in women and 76% in men (p = 0.019); corresponding rates in those with severe OSAS (AHI > 30/h) were 100% and 68% (p = 0.0015). In women vs. men, overall complete response rates at AHI cut-off values of < 5/h, <10/h, and < 15/h were 49 vs. 34% (p = 0.0052), 78 vs. 62% (p = 0.016), and 92 vs. 76% (p = 0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy., Conclusions: MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS., Trial Registration: www.clinicaltrials.gov (NCT01326143).

Background: Mandibular repositioning devices (MRDs) are usually recommended as the first therapy option in patients with mild-to-moderate obstructive sleep apnoea (OSA). However, data on the long-term efficacy of MRDs are limited, not only in OSA patients who are noncompliant with continuous positive airway pressure (CPAP) but also in those with more severe OSA. The ORCADES study aimed to prospectively determine the long-term efficacy and tolerability of two custom-made Narval(™) MRDs for obstructive sleep apnoea-hypopnoea syndrome (OSAHS) patients. The interim 3- to 6-month data are reported., Methods: Eligible patients had OSAHS and had refused or were noncompliant with prescribed CPAP. Outcome measurements after gradual mandibular advancement titration included: apnoea-hypopnoea index (AHI), oxygen saturation, sleepiness, symptoms, quality of life, side effects and compliance., Results: A total of 369 patients were included. Overall, MRD treatment was successful (≥50% decrease in AHI) in 76.2% of the participants; complete response (AHI <10/h) was achieved in 63.5%. Severe OSAHS was effectively treated (AHI <15/h) in about 60% of the participants; 38% had complete symptom resolution. Mandibular repositioning devices significantly decreased subjective sleepiness, eliminated symptoms and improved quality of life. They were well tolerated and compliance was excellent. Only 8% of the participants stopped MRD treatment due to side effects., Conclusion: Custom-made Narval(™) MRDs are effective for mild to severe OSA in patients who refuse or are noncompliant with CPAP. They are well tolerated and have excellent compliance., (Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Optimizing the measurement of Continuous Positive Airway Pressure (CPAP) compliance and treatment efficacy is paramount for patients with obstructive sleep apnea syndrome (OSAS). Compliance knowledge is currently based on data coming from CPAP machines; however algorithms and measured parameters vary from one machine to another. This study was conducted to clinically evaluate a novel device, NOWAPI(®), designed to assess compliance remotely in conjunction with any CPAP machine. NOWAPI(®) was tested against polygraphy, the gold standard for the measurement of CPAP treatment duration and residual apnea-hypopnea index (AHI)., Methods: Single group assignment, open label, non-randomized. Sleep laboratory setting. 22 adult patients with OSAS treated by CPAP were included. Recordings were performed during one night while the patient was treated with his/her usual CPAP and interface. NOWAPI(®) data were collected electronically and compared to data acquisition and visual scoring using an EMBLETTA(®) GOLD polygraph. Statistics were only descriptive., Results: Recordings were performed with six different CPAP machines and three different interfaces (full facemask, nasal pillow, nasal mask). The median [Q1; Q3] absolute difference in CPAP treatment duration between NOWAPI(®) and polygraphy was of 1.0 min [0.0; 12.0], corresponding to a relative difference of 0.21 % [0.0; 2.2] (Per Protocol data set, n = 20). NOWAPI(®) tended to underestimate residual AHI in a magnitude of two events per hour as compared to polygraphy. The device was well tolerated and the patient satisfaction was good., Conclusions: This clinical study confirmed prior bench tests, showing that NOWAPI(®) estimate of CPAP treatment duration was clinically acceptable and in agreement with polygraphy. Although a limited number of OSAS patients treated by CPAP were included, relevant findings for the device improvement were identified. Trial Registration ClinicalTrials.gov identifier: NCT01441622. The study was funded by Air Liquide HealthCare.

Obstructive sleep apnea syndrome (OSA) alters sleep quality and is associated with sleepiness and decreased cognitive functioning. It has therefore always been recognized as a major public health issue with potential societal consequences: accidents, increased morbidity, and cognitive deficits impairing work efficiency. The number of patients diagnosed and treated for OSA has increased drastically in the last few years. In response to this epidemic, health authorities have encouraged studies investigating how patients cope with OSA and also its diagnosis, comparing ambulatory to hospital-based polysomnography. Based on epidemiological knowledge, this review aims to carefully describe the possible links between sleep apnea and public health concerns along with identifying the certitudes and missing data concerning the consequences of sleep apnea on accidents, work, economics and health-related quality of life., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objective: While the Berlin Sleep Questionnaire (BSQ) was developed to identify patients at high risk of having sleep apnea, assessment can be difficult in patients suffering from impaired cognitive functions (i.e., stroke patients). We therefore created a modified version of the questionnaire to be used in patients' bed partners to test whether it could give identical results to the original form of BSQ., Methods: The BSQ was filled in by 90 patients hospitalized in our Sleep Clinic for polysomnographic recording and by 33 healthy control subjects recorded polysomnographically. An adapted version of the BSQ was completed by each bed partner., Results: Sixty of the 123 subjects had a Respiratory Disturbance Index (RDI)>5 and 49.6% of them were classified as being at high risk of having sleep apnea with both questionnaires. Being in the high-risk group with the self-reported Berlin questionnaire predicted an RDI>15 with a sensitivity of 0.76 and a specificity of 0.61 versus a sensitivity of 0.82 and a specificity of 0.63 with the bed-partner Berlin questionnaire. Being in the high-risk group with the self-reported Berlin questionnaire predicted an RDI>30 with a sensitivity of 0.71 and a specificity of 0.53 versus a sensitivity of 0.79 and a specificity of 0.54 with the bed-partner Berlin questionnaire., Conclusions: The bed-partner Berlin questionnaire predicts an RDI>15 with a better sensitivity and specificity than the original questionnaire. It could, therefore, be used in bed partners of patients suspected of obstructive sleep apnea syndrome who cannot fill in the self-reported Berlin questionnaire., (Copyright 2010 Elsevier B.V. All rights reserved.)

Unlabelled: This prospective study aimed to assess symptomatic evolution of patients diagnosed with Upper Airway Resistance Syndrome (UARS) four and half years after the initial UARS diagnosis. For this purpose, 138 UARS patients were contacted by mail between 43 and 69 months after the initial evaluation; 105 responded to the letter and 94 patients accepted to undergo new clinical and polysomnographic evaluations. Initial and follow-up polysomnographic recordings were scored using the same criteria., Results: Of the 94 patients who completed the follow-up examination, none of them were using nasal CPAP. It was related to refusal by insurance providers to provide equipment based on initial apnea-hypopnea index (AHI) in 90/94 subjects. Percentage of patients with sleep related-complaints significantly increased over the four and half year period: daytime fatigue, insomnia and depressive mood increased by 12 to 20 times. Reports of sleep maintenance sleep onset insomnia and depressive mood was significantly increased. Hypnotic, antidepressant and stimulant prescription increased from initial to follow-up visit (from 11.7% to 61.7%; from 3.2% to 25.5% and from 0% to 9.6%, respectively) with antidepressant given as much for sleep disturbance as mood disorder. The polysomnography results at follow-up showed that 5 subjects had AHI compatible with Obstructive Sleep Apnea Syndrome (OSAS) but overall, respiratory disturbance index had no significant change. Total sleep time was significantly reduced compared to initial visit., Conclusions: Many UARS patients remained untreated following initial evaluation. Worsening of symptoms of insomnia, fatigue and depressive mood were seen with absence of treatment of UARS.