Comparison of mandibular advancement splint and tongue stabilizing device in obstructive sleep apnea: a randomized controlled trial.
OBJECTIVE
To compare the efficacy of a mandibular advancement splint (MAS) and a novel tongue stabilizing device (TSD) in the treatment of obstructive sleep apnea (OSA).


METHODS
A randomized crossover design was used.


METHODS
Twenty-seven patients (20 male, 7 female), recruited from a tertiary hospital sleep clinic.


RESULTS
The apnea-hypopnea index (AHI) was reduced with MAS (11.68 +/- 8.94, P = 0.000) and TSD (13.15 +/- 10.77, P = 0.002) compared with baseline (26.96 +/- 17.17). The arousal index decreased for MAS (21.09 +/- 9.27, P = 0.004) and TSD (21.9 +/- 10.56, P = 0.001) compared with baseline (33.23 +/- 16.41). Sixty-eight percent of patients achieved a complete or partial response with MAS, compared with 45% with TSD. The Epworth Sleepiness Scale (ESS) score was decreased with MAS (P = < 0.001) and TSD (P = 0.002). Subjective improvements in snoring and quality of sleep were reported, with a better response for MAS than TSD. Compliance was poorer for TSD, and the side effect profiles of the 2 modalities were different. All patients were satisfied with MAS compared to TSD, and 91% of patients preferred the MAS.


CONCLUSIONS
Objective testing showed the MAS and TSD had similar efficacy in terms of AHI reduction. Patients reported improvements with both devices; however, better compliance and a clear preference for MAS was apparent when both devices were offered. Longer term studies are needed to clarify the role of TSD.
Deane
Sheryn A
SA
Department of Orthodontics, Faculty of Dentistry, University of Sydney, Sydney Dental Hospital, Sydney, Australia.
Cistulli
Peter A
PA
Ng
Andrew T
AT
Zeng
Biao
B
Petocz
Peter
P
Darendeliler
M Ali
MA
D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation*; D008875:Middle Aged; D017090:Occlusal Splints; D016382:Orthodontic Appliance Design; D009968:Orthodontic Appliances, Removable; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000628:therapy*; D014059:Tongue