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Chronic sleep deprivation has been associated with cognitive impairment (CI) in multiple studies. Cognivue is an FDA-cleared computerized testing tool that provides adaptive psychophysic evaluation of cognitive functions (CF). A reliable objective method to evaluate CF in patients with sleep disorders could be helpful to optimize long-term treatment. In an FDA clearance study, Cognivue demonstrated good agreement with St. Louis University Mental Status (SLUMS) and other neuropsychological tests, and superior test re-test reliability compared to SLUMS across 2 sessions, 1 to 2 weeks apart (Cognivue regression fit: R2= 0.81, r= 0.90); SLUMS regression fit: R2 = 0.67, r= 0.82). Methods 238 subjects from the FDA clearance study enrolled in the longitudinal study. They underwent Cognivue test and SLUMS at 3 sessions over 18 months (6, 12, 18 months post-FDA study). An analysis of rank linear regression test-retest reliability was performed for both tests. Results Among these 238 patients, Cognivue demonstrated similar linear regression scores across comparisons (test session 1&amp;2: regression fit: R2= 0.76; r = 0.87; test session 1&amp;3: regression fit: R2= 0.72; r = 0.85; test session 1&amp;4: regression fit: R2= 0.73; r = 0.86). The SLUMS test demonstrated greater variability in regression scores across test sessions (test session 1&amp;2: regression fit: R2= 0.63; r = 0.79; test session 1&amp;3: regression fit: R2= 0.43 r = 0.65; test session 1&amp;4: regression fit: R2= 0.64; r = 0.80). Conclusion Cognivue demonstrated maintained superior test re-test reliability compared to SLUMS over a period of 18 months after the FDA clearance study. With that, Cognivue could be beneficial in detecting early stages of multi-domain CI in patients with sleep disorders, providing an opportunity for early intervention strategies and follow-up over time to improve patient outcomes. Support Cognivue, Inc.

1119 Superior Test-Retest Reliability of a Computerized Cognitive Assessment vs SLUMS During an 18-Month Longitudinal Study