0751 Epworth Sleepiness Scale Test-Retest Reliability Analysis In Solriamfetol Studies

Abstract

Abstract Introduction The Epworth Sleepiness Scale (ESS) measures excessive daytime sleepiness. This analysis examined test-retest reliability of ESS scores in participants with narcolepsy or obstructive sleep apnea (OSA) in solriamfetol studies. Methods Intraclass correlation coefficient (ICC) estimates and 95% confidence intervals (CIs) for ESS scores from two 12-week, placebo-controlled trials (1 narcolepsy; 1 OSA), and one long-term open-label extension (OLE) trial (narcolepsy or OSA) were calculated separately for each trial, based on assessments (at time-point pairs) when scores were expected to be stable (at weeks 4 and 8, 8 and 12, and 4 and 12 in the 12-week trials, and weeks 14 and 26/27, 26/27 and 39/40, and 14 and 39/40 in the OLE). ICCs were analyzed for the overall population in each trial and by treatment and adherence to primary OSA therapy. An ICC >0.7 has been recommended as a quality criterion for acceptable test-retest reliability. Results In the 12-week narcolepsy trial, ICCs (95% CI) were 0.83 (0.79, 0.87) for weeks 4 and 8 (n=199), 0.87 (0.83, 0.90) for weeks 8 and 12 (n=196), and 0.81 (0.76, 0.85) for weeks 4 and 12 (n=196). In the 12-week OSA trial, ICCs (95% CI) were 0.74 (0.69, 0.78) for weeks 4 and 8 (n=416), 0.80 (0.76, 0.83) for weeks 8 and 12 (n=405), and 0.74 (0.69, 0.78) for weeks 4 and 12 (n=405). In the OLE trial, ICCs (95% CI) were 0.82 (0.79, 0.85) for weeks 14 and 27/26 (n=495), 0.85 (0.82, 0.87) for weeks 27/26 and 40/39 (n=463), and 0.78 (0.74, 0.81) for weeks 14 and 40/39 (n=463). Treatment (solriamfetol combined/placebo) or adherence to primary OSA therapy did not impact reliability. Conclusion In 3 large clinical trials of participants with narcolepsy or OSA, the ESS demonstrated an acceptable level of test-retest reliability. Support Jazz Pharmaceuticals