Oral Appliance Therapy versus Nasal Continuous Positive Airway Pressure in Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial

Abstract

Background: Previous randomized controlled trials have addressed the efficacy of mandibular advancement devices (MADs) in the treatment of obstructive sleep apnea (OSA). Their common control condition, nasal continuous positive airway pressure (nCPAP), was frequently found to be superior to MAD therapy. However, in most of these studies, only nCPAP was titrated objectively but not MAD. To enable an unbiased comparison between both treatment modalities, the MAD should be titrated objectively as well. Objective: The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device. Methods: Sixty-four mild/moderate patients with obstructive sleep apnea (OSA; 52.0 ± 9.6 years) were randomly assigned to three parallel groups: MAD, nCPAP and placebo device. From all patients, two polysomnographic recordings were obtained at the hospital: one before treatment and one after approximately 6 months of treatment. Results: The change in the apnea-hypopnea index (ΔAHI) between baseline and therapy evaluation differed significantly between the three therapy groups (ANCOVA; p = 0.000). No differences in the ΔAHI were found between the MAD and nCPAP therapy (p = 0.092), whereas the changes in AHI in these groups were significantly larger than those in the placebo group (p = 0.000 and 0.002, respectively). Conclusion: There is no clinically relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objectively.

Anatomically Based Outcome Predictors of Treatment for Obstructive Sleep Apnea with Intraoral Splint Devices: A Systematic Review of Cephalometric Studies

“…As a further aspect for investigation, more information should be drawn from the amount of the advancement that is required to achieve the best balance between benefit and discomfort, which was shown to be a critical aspect in the OSA literature. 33 Moreover, as a further limitation of this review, it should be noted that the external validity is not optimal due to the poor consistency between the reviewed studies as far as the methodological features are concerned.…”

The Comparison of CPAP and Oral Appliances in Treatment of Patients With OSA: A Systematic Review and Meta-analysis

“…19,20 Finally, 14 studies were included in this metaanalysis. [10][11][12][13][14][15][21][22][23][24][25][26][27][28] Among these studies, 8 trials had a crossover design, [10][11][12]15,[21][22][23]27 and 6 had a parallel-group design. 13,14,[24][25][26]28 The main characteristics of the included studies are shown in Table 2.…”

“…14,22,[24][25][26]28 Adequate method for allocation concealment was applied in 3 trials. 14,27,28 In one trial, 28 the subjects remained blinded to the nature of therapy, and examiner blinding was performed in 3 trials. 22,27,28 The description of follow-up was considered adequate in all included trials.…”

Mandibular Advancement Splint as Short-Term Alternative Treatment in Patients with Obstructive Sleep Apnea Already Effectively Treated with Continuous Positive Airway Pressure

“…In randomized controlled trials comparing both modalities of treatment, CPAP therapy is consistently more effective in reducing sleep disordered breathing events. [6][7][8][9] While CPAP and MAS have similar subjective and cardiovascular outcomes, patients tolerate MAS better. [8][9][10][11] The superior patient satisfaction associated with the use of MAS reflects the relative simplicity and convenience of this form of treatment.…”

“…[6][7][8][9]19 Randomized control trials have shown no significant differences in subjective sleepiness and quality of life when comparing CPAP to MAS. 8,20,21 Our study showed an interesting and important finding in terms of daytime sleepiness.…”