The efficacy of a novel tongue-stabilizing device on polysomnographic variables in sleep-disordered breathing: a pilot study.

The polysomnographic efficacy of a novel tongue-stabilizing device (TSD) in the treatment of snoring and sleep-disordered breathing (SDB) was evaluated in this pilot study. Six current users of the TSD with SDB underwent polysomnography with and without the TSD in situ in a randomized crossover design. The TSD significantly lowered the frequency of snores per hour slept (61- to 70-dB range) (no TSD: mean = 41/h slept +/- 52 SD; TSD: 8/h slept +/- 16 SD; P = 0.046) but did not alter snoring in the other decibel ranges (all Ps > 0.1). Trends were found for reductions in the frequency of apneas plus hypopneas (no TSD: 26/h slept +/- 17/h slept; TSD: 15/h slept +/- 13; P = 0.06) and oxygen desaturations of 4% or more (no TSD: 10/h slept +/- 10; TSD: 5/h slept +/- 5; P = 0.09). Significant improvements in microarousal frequency with the TSD were found (no TSD: 34/h slept +/- 16; TSD: 22/h slept +/- 14; P = 0.004). Significant reductions in percentage of Stage 1 sleep with the TSD were also demonstrated (no TSD: 10 +/- 3%; TSD: 8 +/- 2%; P = 0.03). The results of this small pilot study indicate that the TSD may be effective in reducing snoring severity and microarousals, with favorable trends for reducing SDB severity in selected individuals. Additional larger prospective studies are required to identify suitable candidates for TSD use in the treatment of snoring and SDB.

RCT Entities:   Population Interventions Outcomes