NCT02045576.

No abstract

PurposeThe Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA.MethodsThis prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5–30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months’ follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed.ResultsNinety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months (P < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h (P < 0.001), with no significant between-group difference (P = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group (P = 0.598).ConclusionsThe efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups.Trial registration: www.clinicaltrials.gov (NCT02045576).Electronic supplementary materialThe online version of this article (10.1007/s11325-017-1568-4) contains supplementary material, which is available to authorized users.

No abstract

PurposeA high prevalence of obstructive sleep apnea (OSA) is seen in edentulous individuals. Treatment options for edentulous OSA patients however are limited with continuous positive airway pressure therapy (CPAP) remaining the current therapy of choice. As CPAP is associated with high non-adherence rates and oral appliance therapy requiring sufficient dentition, there is a clinical need for effective treatment strategies aimed at edentulous OSA patients. The purpose of this study was to present a thorough overview of the literature regarding (1) the effects of nocturnal denture wearing on OSA, (2) the outcomes of oral appliance therapy, and (3) surgical treatment in edentulous OSA patients.MethodsA computer-assisted literature search was performed in the MEDLINE database on “edentulism” and “obstructive sleep apnea.” The search yielded a total of 34 original articles.ResultsA total of 20 studies were included after exclusion of non-relevant, duplicate, and non-English publications, comprising 4 randomized clinical trials, 12 case reports, and 4 cohort or cross-sectional studies. The outcomes of these studies were addressed in detail concerning nocturnal wearing of dentures, oral appliance therapy, and surgical treatment.ConclusionCurrently, there is no consensus in the literature on the effects of nocturnal wearing of dentures on OSA. Several studies report the successful use of oral appliance therapy, including implant-retained mandibular advancement devices (MADs), in selected cases of edentulous patients with varying stages of OSA. Little evidence is available regarding outcomes of surgical procedures in edentulous patients. Based on the results of this literature overview, the paucity of effective evidence-based treatment strategies for edentulous OSA patients indicates the further need of clinical studies to improve clinical management.

No abstract

No abstract

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.