A randomized, controlled, crossover study of a noncustomized tongue retaining device for sleep disordered breathing.

Tongue retaining devices (TRDs) are one type of oral appliance used to treat sleep disordered breathing. Previous studies have evaluated customized TRDs in comparison to mandibular repositioner appliances. The purpose of this study was to evaluate a noncustomized TRD compared to a control device. A randomized, controlled, crossover design was utilized. The primary outcome was the difference in reduction of the respiratory disturbance index (RDI) between the active suction device (S) and the control, nonsuction device (NS). Secondary outcomes included snoring index, Epworth Sleepiness Scale as well as patient and partner quality-of-life index. Crossover analysis found that only the S device significantly reduced the RDI by 4.9 (95% confidence interval 0.85-8.9) events more than the NS device. This represented a reduction in mean RDI from baseline of 15.5 (+/-17.6) to 8.9 (+/-7.6) with the S device. Significant reduction in snoring index was also only found with the S device (214.7-132.9 per hour). Fifty-four percent of subjects indicated they would continue to use only the S device. The S device, with suction, showed better objective and subjective outcomes. Future studies are needed to evaluate these types of devices in larger populations with a wide range of disease severity.

RCT Entities:   Population Interventions Outcomes