Effects of the combination of novel eye mask sleep position therapy device and oral appliance on positional OSA: A multi-arm, parallel-group randomized controlled trial

Abstract

ObjectivesWe explored whether a new combination of eye mask sleep position therapy (SPT) and oral appliance therapy (OAT) was more effective at treating positional obstructive sleep apnea (POSA) than was the use of either device alone. MethodsIn this randomized controlled trial, 60 POSA subjects diagnosed by standard polysomnography (PSG) were divided into three groups (ratio 1:1:1): SPT, OAT, and SPT combined with OAT (SOT). Participants underwent hospital-based follow-ups during months 1 and 6 after beginning treatment. The primary outcome was the decline in the apnea hypopnea index (AHI) at month 6. The secondary outcomes were changes in oxygen-derived parameters and the curative effect at month 6. ResultsAfter 6 months of treatment, PSG showed that SPT, OAT, and SOT all improved the AHI and oxygen-derived parameters. The AHI decline was significantly better in the SOT group than in the OAT or SPT group (71.58% [50.56–84.84%] for SOT, 44.42% [21.23–67.52%] for OAT, and 33.24% [19.03–54.62%] for SPT at 6 months) (P = 0.018 and P < 0.001 for the comparisons of SOT with OAT and SOT with SPT, respectively). In terms of oxygen-derived parameters, only the sleep apnea-specific hypoxic burden (SASHB) improved more in the SOT group (76.89% [57.43–85.91%]) than in the other groups (44.73% [32.38–72.69%] for OAT and 41.82% [15.40–65.24%] for SPT, P = 0.002 and P < 0.001 for the comparisons of SOT with OAT and SOT with SPT, respectively). The efficacies of SPT, OAT, and SOT were 36.84%, 50%, and 80% at 6 months; the SOT group evidenced the highest value (rate ratio [95% confidence interval] 1.78 (1.05–3.03), P = 0.048 and 2.17 (1.16–4.07), P = 0.010, for the comparisons of SOT with OAT and SOT with SPT, respectively). ConclusionThe combination of SPT and OAT was better than either treatment alone and may represent a good option for the treatment of POSA. Trial registrationChinese Clinical Trial Registry; URL: http://www.chictr.org.cn/showproj.aspx?proj=42,852; No. ChiCTR1900025584.