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.

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.