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

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.

Source: BMJ Open - May 25, 2017 Category: General Medicine Authors: Xu, H., Wang, H., Guan, J., Yi, H., Qian, Y., Zou, J., Xia, Y., Fu, Y., Li, X., Jiao, X., Huang, H., Dong, P., Yu, Z., Yang, J., Xiang, M., Li, J., Chen, Y., Wang, P., Sun, Y., Li, Y., Zheng, X., Jia, W., Yin, S. Tags: Open access, Ear, nose and throat/otolaryngology Protocol Source Type: research