Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease
Abstract
This study addresses the widely recognized and heretofore incompletely managed cognitive, and cardiovascular (CV) secondary complications in military veterans and non-veterans with SCI. In this prospective randomized controlled trial, we will objectively measure sleep disordered breathing (SDB) in chronic SCI patients using portable sleep studies, and systematically evaluate the association between SDB, cognitive performance, mood, pain, and CV measures. We will randomize participants to 4 months of PAP or placebo. We will re-evaluate cognitive measures, quality of life, sleep quality, mood and CV outcomes after 4 months of therapy to determine whether PAP therapy has improved baseline impairments. There is minimal risk to study participants and significant potential for immediate and lasting benefits. In the first year of the study, we have completed the manual of study operations, designed a secure study database for data gathering, obtained local IRB approval at all study sites, and DoD approval for the University of Miami and Miami VA sites. Study equipment has been purchased. Research coordinators have been trained and we have enrolled 15 subjects at approved sites. Our first subject will be randomized shortly.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 30, 2015
- Accession Number
- AD1001435
Entities
People
- Shirin Shafazand
Organizations
- University of Miami