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

Weijun Huang; Chenyang Li; Jianyin Zou; Xiaoting Wang; Jingyu Zhang; Jian Guan; Hongliang Yi; Shankai Yin

doi:10.1016/j.sleep.2022.12.017

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

Sleep Med. 2023 Feb:102:52-63. doi: 10.1016/j.sleep.2022.12.017. Epub 2022 Dec 29.

Authors

Weijun Huang¹, Chenyang Li¹, Jianyin Zou¹, Xiaoting Wang¹, Jingyu Zhang¹, Jian Guan¹, Hongliang Yi², Shankai Yin¹

Affiliations

¹ Department of Otorhinolaryngology Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngology Institute of Shanghai Jiao Tong University, Shanghai, China.
² Department of Otorhinolaryngology Head and Neck Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngology Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: yihongl@126.com.

PMID: 36599196
DOI: 10.1016/j.sleep.2022.12.017

Abstract

Objectives: We 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.

Methods: In 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.

Results: After 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).

Conclusion: The combination of SPT and OAT was better than either treatment alone and may represent a good option for the treatment of POSA.

Trial registration: Chinese Clinical Trial Registry; URL: http://www.chictr.org.cn/showproj.aspx?proj=42,852; No. ChiCTR1900025584.

Keywords: Oral appliance therapy; Positional obstructive sleep apnea; Randomized controlled trial; Sleep position therapy.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Mandibular Advancement*
Polysomnography
Sleep
Sleep Apnea Syndromes*
Sleep Apnea, Obstructive*

Associated data

ChiCTR/ChiCTR1900025584