Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
Technical Report,30 Sep 2015,29 Sep 2016
University of Miami Coral Gables United States
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There is a paucity of information on the impact of sleep disordered breathing SDB and its treatment in chronic spinal cord injury SCI.Despite the increased prevalence reported in the literature, screening for SDB and its treatment are not yet standard of care. To enable change in practice, well designed randomized placebo-controlled trials RCT are needed to demonstrate the importance of SDB and its treatment on the health of this population. The central hypothesis of this study is that the treatment of SDB with positive airway pressure PAP will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease CVD surrogate measures in persons with chronic SCI. The Specific Aims are 1 Determine the associations between SDB and cognitive impairment and evaluate the impact of PAP therapy on cognitive measures, and 2 Determine the impact of PAP therapy on surrogate CV biomarkers, sleep quality, quality of life, mood, and pain, in a cohort with chronic SCI and SDB. This is a four-year multi-center double blinded, placebo controlled RCT. We will objectively measure SDB in chronic SCI participants using portable unattended polysomnography, and randomize those with SDB to four months of therapeutic PAP vs. sham PAP placebo. We will measure cognitive performance memory, attention, and executive function using a battery of standardized neuro-cognitive tests PASAT primary outcome. Additionally, we will measure surrogate CVD biomarkers. All measurements will be done at baseline and four-month follow-up.
- Medicine and Medical Research