Obstructive sleep apnea and snore treatment with tongue stabilizer device: randomized clinical trial, preliminary data

Introduction Obstructive sleep apnea (OSA) treatment with intra-oral devices can be effective especially in mild/moderate OSA. The tongue retention devices (TRDs) demonstrated significantly respiratory events reduction during sleep and improved sleep quality. Objective. Evaluate the efficacy of TRDs in the treatment of OSA. Materials and methods We included patients with OSA treated in outpatient clinic Neuro-Sono Sleep Center, Neurology Department, Escola Paulista de Medicina, Sao Paulo, Brazil. Patients with mild or moderate OSA on polysomnography were randomized to start treatment with one of two types of interventions: TRD or dental splint (placebo). Patients were treated for four weeks and then the second polysomnography was performed using the interventions that were randomly allocated. This study continues under blinding and interventions are referred to as A or B, to keep the allocation concealment. Results We consecutively included 75 patients, of whom 15 did not meet the inclusion criteria and 18 did not attend for evaluations. Forty-two patients were randomized. Twenty-one began treatment with device A and 21 with device B. There were 7 dropouts in total. Among the patients who used device A, only one patient showed no snoring at the end of treatment, compared to 9 patients in group B ( p  = 0.008). In the intra- group analysis, for intervention with device A, there was no difference in mean AHI at baseline and at the endpoint, and for device B, the mean AHI decreased from 18.4 to 12.1 events/h ( p  = 0.05). In the inter group analysis, there was no significant difference in mean AHI between the two devices, but 44% of patients who used device B decreased AHI to less than 10 events/ hour, compared to zero in the group with device A. Conclusion Intervention with devices A and B showed statistically significant differences, but the effect of the interventions with both devices appear to be discrete, and device B seems more effective in solving snoring problems. Acknowledgements Supported by FAPESP 2009/16758–4, 2010/02633–2, #2010/06188–3.