Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data.

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.

Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data.

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.

Mandibular advancement reveals long-term suppression of breathing discomfort in patients with obstructive sleep apnea syndrome.

Obstructive sleep apnoea syndrome (OSAS) patients do not report breathing discomfort in spite of abnormal upper airway mechanics. We studied respiratory sensations in OSAS patients without and with mandibular advancement device (MAD). Fifty-seven moderate to severe non obese OSAS patients were asked about breathing discomfort using visual analogue scales (VAS) in the sitting position (VAS-1), after lying down (VAS-2), then with MAD (VAS-3). Awake critical closing pressure (awake Pcrit) was measured in 15 patients without then with MAD. None of the patients reported breathing discomfort when sitting but 19 patients (33%) did when lying (VAS-2: -20% or less). A feeling of "easier breathing" with MAD was observed and was more marked in patients reporting breathing discomfort when supine (VAS-3: +66.0% [49.0; 89.0]) than in those not doing so (VAS-3: +28.5% [1.0; 56.5], p = 0.007). MAD-induced change in awake Pcrit was correlated to VAS-3. In conclusion, MAD revealed "latent dyspnea" related to the severity of upper airways mechanics abnormalities in OSAS patients.

Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome.

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).

Predictors of long-term effectiveness to mandibular repositioning device treatment in obstructive sleep apnea patients after 1000 days.

OBJECTIVE/BACKGROUND: In obstructive sleep apnea (OSA), long-term adherence to treatment is crucial. This prospective single-center study investigated factors associated with long-term adherence to mandibular repositioning device (MRD) therapy. PATIENTS/METHODS: All OSA patients who had MRD treatment initiated in the previous year were prospectively contacted to evaluate long-term effectiveness and compliance. Long-term adherence was based on continuation of treatment (yes/no). Predictors of long-term adherence were analyzed using an adjusted multivariate analysis. RESULTS: Median follow-up was 1002 days (interquartile range: 668-1345) in 279 patients (age 58 [50-64] years); 63% of patients were continuing MRD treatment with a good efficacy, tolerability and compliance over time. In some patients, relapse of nocturia was observed while efficacy was maintained for snoring and somnolence. In adjusted multivariate analysis, significant predictors of continuing MRD treatment were early ≥50% reduction in AHI (odds ratio [OR] 2.73, 95% confidence interval [CI] 1.466-5.10; p = 0.0002) and complete symptom resolution (OR 3.83, 95% CI 1.74-8.48; p = 0.0014). In the 37% of patients who stopped MRD treatment, median treatment duration was 351 (174-752) days. The main reasons for late stopping of treatment were inefficacy (26.2%), discomfort (25.2%) and side effects (21.4%). CONCLUSIONS: After three years, MRD was effective for the two-thirds of OSA patients who continued treatment. Relapse of nocturia might be an early signal of MRD wear that may explain long-term cessation of treatment in some patients. Short-term control of OSA by MAD was predictive of long-term efficiency. The major criteria were a ≥50% reduction in AHI and complete symptom resolution at short-term evaluation.

Reduced survival in patients with ALS with upper airway obstructive events on non-invasive ventilation.

INTRODUCTION: Non-invasive ventilation (NIV) is part of standard care in amyotrophic lateral sclerosis (ALS). Intolerance or unavailability of NIV, as well as the quality of correction of nocturnal hypoventilation, has a direct impact on prognosis. OBJECTIVES: We describe the importance of NIV failure due to upper airway obstructive events, the clinical characteristics, as well as their impact on the prognosis of ALS. METHODS: Retrospective analysis of the data of 190 patients with ALS and NIV in a single centre for the period 2011-2014. 179 patients tolerating NIV for more than 4 h per night without leaks were analysed. RESULTS: Among the 179 patients, after correction of leaks, 73 remained inadequately ventilated at night (defined as more than 5% of the night spent at <90% of SpO2), as a result of obstructive events in 67% of cases (n=48). Patients who remained inadequately ventilated after optimal adjustment of ventilator settings presented with shorter survival than adequately ventilated patients. Unexpectedly, patients with upper airway obstructive events without nocturnal desaturation and in whom no adjustment of treatment was therefore performed also presented with shorter survival. On initiation of NIV, no difference was demonstrated between patients with and without upper airway obstructive events. In all patients, upper airway obstruction was concomitant with reduction of ventilatory drive. CONCLUSIONS: This study shows that upper airway obstruction during NIV occurs in patients with ALS and is associated with poorer prognosis. Such events should be identified as they can be corrected by adjusting ventilator settings.

A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study.

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.