0577 Effect of Continuous Positive Airway Pressure on Quality of Life Measures in Moderate to Severe Obstructive Sleep Apnea: Sleep Apnea Stress Study Randomized Controlled Trial

Abstract

Abstract Introduction Although there has been recent emphasis on importance of patient reported outcomes (PRO) in obstructive sleep apnea (OSA), few studies have systematically examined treatment impact. We leveraged a randomized clinical trial to examine the hypothesis that continuous positive airway pressure (CPAP) improves PRO in moderate to severe OSA. Methods Sleep Apnea Stress Study (SASS) is a single-center, parallel, randomized controlled trial (RCT) designed to examine impact of 2-month CPAP versus sham in moderate to severe OSA (Apnea Hypopnea Index>15) on cardiovascular measures (ClinicalTrials.govNCT00607893). Collected quality of life measures included Calgary SAQLI (Sleep Apnea Quality of Life Index), FOSQ (Functional Outcome of Sleep Questionnaire), SF36 (Short Form Health Survey), ESS (Epworth Sleepiness Scale), PANAS (Positive and Negative Affect Schedule), CESD (Center for Epidemiological Studies Depression). Linear regression models were used to compare change between CPAP and sham groups (and compliant/non-compliant CPAP subgroups) adjusted for baseline measures and follow-up compliance. Subset analysis was performed in patients who had “abnormal” baseline PRO. Results The overall analytic sample was:age51.01+/-11.7yrs, 52.3%Caucasian, 53.7%males, body mass index of 37.2+/-8.1kg/m2. Of 153 participants, 74 were randomized to sham group and 75 to CPAP. None of the PRO showed difference in CPAP versus sham CPAP, although trend for statistical significance was observed for ESS (CPAP:-2.25:-3.18,-1.33 versus sham CPAP:-1.07:-1.98,-0.17, p=0.074). Those compliant with CPAP versus non-compliant demonstrated greater improvement in ESS when compared to sham CPAP[CPAP adherent-least square mean(95%confidence interval)-3.0(-4.3,-1.7)vs. CPAP non-adherent-1.1(-2.3,-0.1)vs.sham CPAP-1.1(-1.95,-0.3), p=0.045]. CPAP versus sham had more improvement in SF-36 Physical component scale(p=0.03)in those with baseline SF-36 Physical Component Scale<45.7(median). Conclusion In this clinical trial with relatively normal baseline range of PRO, no statistically significant improvement in PRO was observed except for ESS in those compliant with CPAP. Furthermore, exploratory subgroup analyses showed greater physical component SF-36 improvement in those with baseline lower scores.