Dataset Information

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

ABSTRACT: Background:The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. Objective:To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. Patients and methods:In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Results:Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). Limitations:The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. Conclusion:In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Trial registration:Registered with ClinicalTrials.gov (#NCT02148510).

SUBMITTER: Isacsson G

PROVIDER: S-EPMC6343726 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

Isacsson Göran G Nohlert Eva E Fransson Anette M C AMC Bornefalk-Hermansson Anna A Wiman Eriksson Eva E Ortlieb Eva E Trepp Livia L Avdelius Anna A Sturebrand Magnus M Fodor Clara C List Thomas T Schumann Mohamad M Tegelberg Åke Å

European journal of orthodontics 20190101 1

<h4>Background</h4>The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA.<h4>Objective</h4>To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective.<h4>Patients and methods</h4>In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were ran ...[more]

PMID: 29771314

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Project description:Rationale: Oral appliance therapy is efficacious in many patients with obstructive sleep apnea (OSA), but prediction of treatment outcome is challenging. Small, detailed physiological studies have identified key OSA endotypic traits (pharyngeal collapsibility and loop gain) as determinants of greater oral appliance efficacy.Objectives: We used a clinically applicable method to estimate OSA traits from routine polysomnography and identify an endotype-based subgroup of patients expected to show superior efficacy.Methods: In 93 patients (baseline apnea-hypopnea index [AHI], ≥20 events/h), we examined whether polysomnography-estimated OSA traits (pharyngeal: collapsibility and muscle compensation; nonpharyngeal: loop gain, arousal threshold, and ventilatory response to arousal) were associated with oral appliance efficacy (percentage reduction in AHI from baseline) and could predict responses to treatment. Multivariable regression (with interactions) defined endotype-based subgroups of "predicted" responders and nonresponders (based on 50% reduction in AHI). Treatment efficacy was compared between the predicted subgroups (with cross-validation).Results: Greater oral appliance efficacy was associated with favorable nonpharyngeal traits (lower loop gain, higher arousal threshold, and lower response to arousal), moderate (nonmild, nonsevere) pharyngeal collapsibility, and weaker muscle compensation (overall R2 = 0.30; adjusted R2 = 0.19; P = 0.003). Predicted responders (n = 54), compared with predicted nonresponders (n = 39), exhibited a greater reduction in AHI from baseline (mean [95% confidence interval], 73% [66-79] vs. 51% [38-61]; P < 0.0001) and a lower treatment AHI (8 [6-11] vs. 16 [12-20] events/h; P = 0.002). Differences persisted after adjusting for clinical covariates (including baseline AHI, body mass index, and neck circumference).Conclusions: Quantifying OSA traits using clinical polysomnography can identify an endotype-based subgroup of patients that is highly responsive to oral appliance therapy. Prospective validation is warranted.

Project description:Study objectivesThe present study addresses the need for a validated tool that prospectively identifies favorable candidates for oral appliance therapy in treatment of obstructive sleep apnea. The objective of the study was to evaluate the ability of a mandibular titration study, performed with a remotely controlled mandibular positioner (RCMP), to predict treatment outcome with a mandibular repositioning appliance (MRA) and to predict an effective target protrusive position (ETPP).DesignA prospective, blinded, outcome study.SettingStandard clinical care with tests performed in the polysomnographic laboratory.ParticipantsConsecutive patients (n = 67) recruited from a sleep center or a dental practice using broad inclusion criteria (age 21-80 years; AHI > 10/h; BMI < 40 kg/m(2)).InterventionsTherapeutic outcome with a mandibular protruding oral appliance was predicted following a mandibular protrusive titration study in the polysomnographic laboratory using a remotely controlled positioner and prospectively established predictive rules. An ETPP was also prospectively determined for participants predicted to be therapeutically successful with MRA therapy. All participants were blindly treated with a MRA, at either the predicted ETPP or a sham position, and therapeutic outcome was compared against prediction.Measurements and resultsAt the final protrusive position, standard predictive parameters (sensitivity, specificity, positive and negative predictive values) showed statistically significant predictive accuracy (P < 0.05) in the range of 83% to 94%. The predicted ETPP provided an efficacious protrusive position in 87% of participants predicted to be therapeutically successful with MRA therapy (P < 0.05).ConclusionsUsing prospectively established rules for interpreting the polysomnographic data, the mandibular titration study predicted mandibular repositioning appliance therapeutic outcome with significant accuracy, particularly with regard to accurately predicting therapeutic success. As well, among the participants predicted to be therapeutically successful with mandibular repositioning appliance therapy, the effective target protrusive position provided efficacious mandibular protrusion in the majority.

Project description:The roles of central nervous mechanisms and cortical output in obstructive sleep apnoea remain unclear. We addressed corticomuscular coupling between cortical sensorimotor areas and lower facial motor units as a mechanistic pathway and as a possible surrogate marker of corticoperipheral motor control in obstructive sleep apnoea. In this exploratory cross-sectional retrospective study, we analysed EEG (C3 and C4 leads) and chin EMG from polysomnography recordings in 86 participants (22 females; age range: 26-81 years): 27 with mild (respiratory disturbance index = 5-15 events/h), 21 with moderate (15-30 events/h) and 23 with severe obstructive sleep apnoea (>30 events/h) and 15 control subjects (<5 events/h). By computing C3-/C4-EEG-chin EMG coherence of signal dynamics in time and frequency domains, we investigated corticomuscular coupling between cortical sensorimotor areas and lower facial motor units with increasing obstructive sleep apnoea severity during the entire sleeping time, during different sleep stages and during obstructive respiratory events, including 5 s before (stable breathing) and after events (breathing resumption). In addition, we studied a possible influence of body mass index and autonomic nervous system activation. We found that both average and respiratory event-specific corticomuscular coupling between cortical sensorimotor areas and lower facial motor units weakened significantly with increasing obstructive sleep apnoea severity, was strongest during N3 and weakened in N1, N2 and rapid eye movement stages (in decreasing order). Coupling increases significantly during the obstructive respiratory events compared with coupling just before and following them. Results were independent of body mass index or autonomic nervous system activation. We conclude that obstructive respiratory events in obstructive sleep apnoea are very strongly associated both quantitatively and temporally with the degree of disconnection within the cortical sensorimotor areas-lower facial motor units pathway. This quite coordinated activity pattern suggests a cortical sensorimotor area-driven obstructive respiratory event pattern generator and a central motor output disorder in obstructive sleep apnoea.

Dataset Information

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

Publications

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

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