Effects of continuous positive airway pressure on neurocognitive architecture and function in patients with obstructive sleep apnoea: study protocol for a multicentre randomised controlled trial

Huajun Xu, Hui Wang, Jian Guan, Hongliang Yi, Yingjun Qian, Jianyin Zou, Yunyan Xia, Yiqun Fu, Xinyi Li, Xiao Jiao, Hengye Huang, Pin Dong, Ziwei Yu, Jun Yang, Mingliang Xiang, Jiping Li, Yanqing Chen, Peihua Wang, Yizhou Sun, Yuehua Li, Xiaojian Zheng, Wei Jia, Shankai Yin, Huajun Xu, Hui Wang, Jian Guan, Hongliang Yi, Yingjun Qian, Jianyin Zou, Yunyan Xia, Yiqun Fu, Xinyi Li, Xiao Jiao, Hengye Huang, Pin Dong, Ziwei Yu, Jun Yang, Mingliang Xiang, Jiping Li, Yanqing Chen, Peihua Wang, Yizhou Sun, Yuehua Li, Xiaojian Zheng, Wei Jia, Shankai Yin

Abstract

Objectives: Many clinical studies have indicated that obstructive sleep apnoea (OSA), the most common chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous positive airway pressure (CPAP) has some neurocognitive protective effects against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture and function remain unclear. Therefore, this multicentre trial was designed to investigate whether and when neurocognitive architecture and function in patients with OSA can be improved by CPAP treatment and to explore the role of gut microbiota in improving neurocognitive function during treatment.

Methods/design: This study will be a multicentre, randomised, controlled trial with allocation concealment and assessor blinding. A total of 148 eligible patients with moderate to severe OSA will be enrolled from five sleep centres and randomised to receive CPAP with best supportive care (BSC) intervention or BSC intervention alone. Cognitive function, structure and function of brain regions, gut microbiota, metabolites, biochemical variables, electrocardiography, echocardiography, pulmonary function and arterial stiffness will be assessed at baseline before randomisation and at 3, 6 and 12 months.

Ethics and dissemination: This study has been approved by the Medical Ethics Committee of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (approval number 2015-79). The results from this study will be published in peer-reviewed journals and at relevant conferences.

Trial registration number: NCT02886156; pre-results.

Keywords: cognitive function; continuous positive airway pressure; gut microbiota; metabolomics; obstructive sleep apnoea.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
The flow diagram of this randomised controlled trial. BSC, best supportive care; CPAP, continuous positive airway pressure; fMRI, functional MRI; PSG, polysomnography.

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