The aim of the study was to evaluate the efficacy of NIV treatment, CPAP and lifestyle changes (control) in the medium and long-term management of patients with OHS. The primary variables were PaCO2 and days of hospitalization, and operating variables were the percentage of dropouts for medical reasons and mortality.
Secondary medium-term objectives were: (1) to evaluate clinical–functional effectiveness on quality of life, echocardiographic and polysomnographic variables; (2) to investigate the importance of apneic events and leptin in the pathogenesis of daytime alveolar hypoventilation and change according to the different treatments; (3) to investigate whether metabolic, biochemical and vascular endothelial dysfunction disorders depend on the presence of apneas and hypopneas and (4) changes in inflammatory markers and endothelial damage according to treatment.
Secondary long-term objectives are to evaluate: (1) clinical and functional effectiveness and quality of life with NIV and CPAP; (2) changes in leptin, inflammatory markers and endothelial damage according to treatment; (3) changes in pulmonary hypertension and other echocardiographic variables, as well as blood pressure and incidence of cardiovascular events, and (4) dropout rate and mortality.